24/7 BIOPHARMA - issue 1 / October 2024

WELCOME

Unveiling a new era in pharmaceutical media

In a world where information is not just power but a necessity, the launch of our new media platform, 24/7 Biopharma, marks a transformative step in how the biopharma industry communicates, collaborates, and innovates. As we prepare to attend CPHI Milan 2024 as an official media partner, we are excited to embark on this journey that promises to redefine industry engagement and elevate the discourse surrounding pharmaceutical advancements. Our new media platform is designed to bridge the gap between biopharma professionals and the wealth of knowledge, insights, and innovations emerging daily. With a focus on delivering high-quality content, expert analysis, and real-time updates, we aim to foster a dynamic community where industry stakeholders can connect, share, and grow together. This platform is not just a publication; it is a hub for collaboration, inspiration, and action in an ever-evolving landscape. Attending CPHI Milan 2024 provides a unique opportunity to showcase this platform to a global audience of industry leaders, innovators, and decision makers. As one of the largest gatherings in the pharmaceutical sector, CPHI Milan is the ideal venue for us to connect with our peers, share our vision, and explore the latest trends and technologies shaping the future of healthcare. Our presence as a media partner underscores our commitment to amplifying the voices of those driving change in the industry. Sustainability and innovation will also take center stage during our time in Milan. Our new media platform will actively engage with thought leaders and innovators who are pioneering sustainable practices and cutting

edge technologies in pharma. By sharing these stories, we hope to inspire a movement towards a more responsible and forward-thinking industry, where collaboration is key to tackling global health challenges. Moreover, CPHI Milan serves as an excellent opportunity for us to gather insights directly from the ground. We will be conducting interviews and capturing the pulse of the event to provide our audience with comprehensive coverage that reflects the diverse and vibrant nature of the pharmaceutical community. Our commitment to delivering timely and relevant content will ensure that our audience remains informed and engaged long after the event concludes. In conclusion, the launch of our new media platform coincides with an exciting chapter in the biopharma industry, and attending CPHI Milan 2024 as a media partner represents our dedication to being at the forefront of this evolution. We invite all industry professionals to join us on this journey as we strive to create a platform that not only informs but inspires action and collaboration. Together, let’s shape the future of biopharma media and drive positive change in healthcare.

ELLIE BRUNI Publishing Director TWENTYFOURSEVENBIOPHARMA

Publishing Director: Ellie Bruni | +44 (0) 7872 516194 ellie.bruni@247biopharma.com Advertising: info@247biopharma.com Editorial contact: Please send your news and suggestions for feature articles to the editorial team at editor@247biopharma.com

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TWENTYFOURSEVENBIOPHARMA is published by BIBO Publishing SL,

ISSN 2516-4481

CONTENTS

CHEMIUM & VALSYNTHESE 40 Chemium & Valsynthese partner for safe & efficient

1 WELCOME

supply of Grignard reagents and more

ALMAC SCIENCE 44 Elemental impurities –

staying ahead of changing regulations

NEWS 4

46 INTERVIEW

VERANOVA 18 Mapping the evolving pharmaceutical development landscape CORDENPHARMA 20 Expanding support to innovators LONZA 26 Transforming pharma: the AI revolution in drug discovery LLS HEALTH 30 Leveraging excipient synergies for improved patient-centricity LOGICA 34 Transforming pharma: the AI revolution in drug discovery

VÍTOR SOUSA Director of Business Development Cerbios-Pharma SA

INDENA 48 Indena CDMO services: full range for clients’ success

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SUNRESIN NEW MATERIALS 66 Innovation in mAb

52 INTERVIEW

urification using affinity chromatography resins based on proprietary rProtein A

SYNGENE INTERNATIONAL 70 The role of quality management in modern CRDMOs

ANDREAS RAABE CEO Adragos Pharma Chairman YPO Board Member MedTech space

DIGITAL VERSION

RENAISSANCE LAKEWOOD 56 The road to commercializing nasal

drug products: Setting up for success with R&D and clinical manufacturing

WOMEN IN SCIENCE

60

BONUS FEATURES from page 73

TATIANA ROSENSTOCK Principal Scientist in in-vitro Neuroscience Sygnature Discovery

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CordenPharma invests €900m in transformational peptide platform expansion in the USA & Europe

CordenPharma has announced its largest strategic investment to date with a committed spend of ~€900m over the next 3 years to grow its Peptide technology platform. These transformational plans consist of two major expansion initiatives occurring in parallel in the US and Europe, including both existing facilities and new constructions designed and built according to the pharmaceutical industry’s most stringent quality and technical standards for short and long peptide manufacturing, including Biologics License Applications (BLA) requirements. The US expansion involves bringing additional Peptide capacity to the CordenPharma Colorado site with the planned construction of a new large-scale manufacturing facility, and an additional increase in manufacturing trains in the existing facility. This is the result of rapidly increasing demand in the Diabetes and Obesity Glucagon-like Peptide 1 (GLP-1) agonist medications market, and comes off the back

of multiple, long-term, multiyear contracts totaling ~€3bn, with potential upsides. The European expansion centers on the construction of a new state-of the-art greenfield facility, with the aim of creating additional Peptide capacity to serve customers from initial early clinical to late-stage commercial manufacturing. The new site will be located in the heart of Europe, fully-integrated within CordenPharma’s existing facility network. In 2022, CordenPharma was acquired by Astorg, a leading Pan European private equity firm, and its ambitious growth plans aim to help the company reach their ~€1bn sales mark for its pioneering Peptide Platform, and ~€1.8bn total group revenue by 2028. Upon completion, the new constructions will be fully integrated within its outstanding network of world-class cGMP manufacturing facilities, along with the dedicated technical and regulatory support by expert teams needed to

needed support to innovators for the benefit of patients. We are honored by the trust our customers have placed in us to deliver expert outsourcing for large multiyear contracts, and our team is proud to contribute decades of peptide manufacturing experience towards these transformative new medicines. In addition, the strong commitment and support of our shareholder Astorg demonstrates their strategic vision for CordenPharma to become the leading CDMO for complex modalities such as Peptides, by offering fully-integrated end-to end services from APIs to Drug Products (for both Injectable and Oral Peptides).” Dr. Signe Michel, Managing Director at Astorg comments: “We are proud of what Michael and the CordenPharma team have achieved through their striving for operational excellence, customer service and ambitious growth. We are excited about the opportunities ahead and to further strengthen the company’s peptide offering across the full drug lifecycle and value chain.” Judith Charpentier, Co-Head Flagship Fund and Head of Healthcare at Astorg comments: “CordenPharma has a unique opportunity to reinforce its leadership position in peptides with unmatched capacity and performance in large scale manufacturing. With the company’s proven track record and our investor experience in pharmaceutical services, we feel confident that our latest commitment will help the company seize this opportunity.”

secure innovators’ supply chains with small to large-scale fully-integrated services from APIs to Drug Products.

Dr. Michael Quirmbach, President

& CEO of CordenPharma

Group comments: “These investments

will profoundly strengthen our

ability to provide valuable and much

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NEWS

Aragen Life Sciences receives Science Based Targets initiative (SBTi) approval for its greenhouse gas emission reduction targets First Indian CRDMO to receive SBTi approval

Aragen Life Sciences, a leading global provider of contract research, development, and manufacturing services for the life sciences industries announced that it has received approval from the UK based Science

more than just a recognition of our efforts; it is a critical step forward in our sustainability journey. These targets underscore our dedication to innovation, collaboration, and transparency in a holistic manner, while ensuring sustainability

Based Targets initiative (SBTi) for its near-term and net zero sustainability targets. SBTi has validated Aragen’s greenhouse gas emission reduction targets to conform with its criteria and recommendations, as outlined in Criteria version 5.1. Aragen’s approved targets: - Overall Net-Zero Target: committed to achieving net-zero greenhouse gas emissions across its value chain by FY2050 - Near-Term Targets: Reducing absolute Scope 1, 2 and 3 GHG emissions by 50.4% by FY2033 (base year FY2023) - Long-Term Targets: Reducing absolute Scope 1, 2, and 3 GHG emissions by 90% by FY2050 (base year FY2023)

measures are in place as we work with the 400+ customers globally. We are determined to make a meaningful and measurable impact in our fight against climate change.” Shivaji Jadhav, VP & Head, EHS & Sustainability at Aragen added, “This approval is an endorsement of the rigorous efforts we’ve put into our sustainability initiatives. It underscores our responsibility to our planet and reinforces our commitment to leading by example in the industry.” The SBTi targets provide a scientifically backed framework for reducing greenhouse gas emissions, in line with the 2015 Paris agreement. This validation marks a historic milestone for Aragen, positioning the company as a leader in climate action within the life sciences sector. It reflects Aragen’s unwavering commitment to reducing its carbon footprint in a meaningful and measurable way and contributing to the collective fight against climate change.

Commenting on the approval, Manni Kantipudi, CEO, Aragen Life Sciences said, “This validation by the SBTi is

Champalimaud Foundation adopts Lonza ’s MODA-ES ® Platform to streamline cell therapy manufacturing

Champalimaud Foundation, a biomedical clinical research organization carrying out research and cutting-edge clinical development and discoveries that benefit people, and Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, announced the installation of Lonza’s MODA

ES ® Platform at the Champalimaud Clinical Centre in Lisbon, Portugal. Through the installation of MODA ES ® , the Champalimaud Foundation plans to improve and streamline the cell therapy manufacturing process, thereby increasing accessibility of life-saving therapies for patients with cancer with unmet medical needs.

In collaboration with academic and industry partners, the Champalimaud Foundation has built a state-of-the-art multipurpose GMP facility to develop biologically and clinically promising cell therapies with industrial standards. The foundation sought a paperless solution to ensure the safety of cell production, unlock transparency

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for current and future partners, and monitor the complex production process from reagent purchase to final product release. Based on these requirements, the Champalimaud Foundation selected Lonza’s MODA-ES ® Platform. This configurable manufacturing execution system (MES) is designed specifically for cell and gene therapy production. It consolidates all manufacturing batch and batch related quality control data into a single record for reduced errors, greater visibility, and expedited

product release. The platform provides advanced traceability and genealogy workflows, which helps to ensure the chain of identity and custody in complex decentralized cell and gene therapy manufacturing processes. The Immunotherapy expert team at Champalimaud chose the Lonza MODA-ES ® Platform owing to Lonza’s proven track record in e-solutions that cover the cellular production process and that provide vital links to the entire operational system of a

GMP facility. Lonza’s deep understanding of cell production, academic medicine, and how to develop and implement electronic documentation solutions is

of great benefit to companies implementing an MES in cell and gene manufacturing while it creates increased transparency for regulatory agencies.

Abzena supplies clinical trial material for Angiex’s Phase I study of AGX101, a first-in-class TM4SF1-directed ADC

Angiex, a developer of Nuclear Delivered Antibody-Drug

manufacturing for Angiex’s Phase 1 trial.

fully integrated approach allowed us to de- risk and rapidly progress AGX101 into the clinic for patient dosing. We will continue supporting Angiex with our extensive ADC expertise and integrated capabilities to accelerate the development timeline of AGX101, and ultimately get this life-changing treatment to cancer patients faster.” The Phase 1 study for AGX101 is an open-label, dose-escalation, and expansion study designed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of AGX101 monotherapy. The dose escalation portion of the study is designed to assess doses up 10 mg/kg in an all- comers, solid tumor patient population. The dose expansion portion of the study is designed to evaluate treatment at the Recommended Phase 2 Dose in multiple indications.

Conjugate™ (ND- ADC) therapies for solid cancers, announced that patient dosing has begun for their Phase 1 clinical trial of AGX101, a first-in class TM4SF1-directed Antibody Drug Conjugate (ADC). Angiex partnered with Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, to support the development, manufacture and supply of clinical trial material for the study. AGX101 is a TM4SF1-directed ADC that targets two compartments of the tumor, cancer cells and the tumor vasculature. AGX101 has three mechanisms of action: eliminating tumor blood vessels, killing tumor cells capable of invasion and metastasis, and directing the immune system to attack the cancer. Abzena has supported the development of AGX101 with an integrated program that included linker-payload design and synthesis, bioconjugation, process development, and cGMP

Paul Jaminet, co-founder and CEO of Angiex, said: “We are very excited to have dosed our first patient in our first-in-human study of our novel TM4SF1 ADC, AGX101. Throughout the development of AGX101, Abzena has worked closely with us to achieve successful GMP manufacturing and quality control. We could not have reached this milestone without Abzena’s expertise, cooperation, and support. Both companies have extensive expertise in their respective fields and an aligned mission, and we look forward to continuing our partnership to ensure that AGX101 is available to meet the needs of clinical cancer patients. We are delighted that Abzena shares our vision that no one should die of cancer.” Matt Stober, CEO of Abzena, said: “The Abzena team is incredibly proud to have helped Angiex achieve this significant milestone. Our unique ability to support Angiex with a

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NEWS

FUJIFILM Irvine Scientific develops Oceo Rover: The first automated single-use hydration system for media and buffers

FUJIFILM Irvine Scientific, Inc., a world leader in the development and manufacture of serum-free and chemically defined cell culture media for bioproduction and cell therapy manufacturing, today announced the development of Oceo Rover, a first-of-its-kind* single-use technology system, that enables manufacturers of biopharmaceuticals to improve bioprocessing workflows by automating and simplifying the hydration of media, feeds, and buffers. The automated Oceo Rover system combines single-use consumables, and dedicated media design services into one single-suite alternative to current stirred tank mixing technologies. Preparing powder media and buffers for use in bioprocessing is a labor intensive process and poses risks related to contamination, variability,

and safety for workers in production suites. The Oceo Rover platform is a novel, automated hydration system that combines prepacked, single-use hydration cartridges with a programmable skid that simplifies the hydration process. It features automation software that is easy to use and delivers the correct volume of water to the bulk powder and supplements at appropriate intervals to optimize the hydration of powder media and buffers. With the Oceo Rover system, media and buffers can be prepared in real-time, alleviating the need to hold large amounts of liquids in cold storage needed to support some workflows such as continuous processing. The integrated, closed system also reduces the risk of cross-contamination and increases regulatory compliance.

“We saw a need in the market to improve the process of hydrating powdered media and buffers. Oceo Rover addresses this need by simplifying the hydration process and delivering the consistency that manufacturers need, while also saving time and costs associated with bioprocessing,” said Yutaka Yamaguchi, chairman, and chief executive officer, FUJIFILM Irvine Scientific. “The Oceo Rover system will help shape the future of single use-technology and bioprocessing operations.” Manufacturers who add the Oceo Rover platform to their bioprocessing operations will also have the support of the FUJIFILM Irvine Scientific Manufacturing Science and Technology Group to identify optimal hydration protocols to meet their media needs.

A commitment to sustainability

Cerbios is proud to share its sustainability journey at CPHI Milan 2024. As a company dedicated to making a positive impact, we’ve been actively working to reduce our carbon footprint and promote sustainable practices. Our sustainability story begins in 2013. That year, we voluntarily engaged with local authorities to reduce our CO2 emissions. Building upon a decade of energy consumption monitoring, we’ve invested in highly efficient equipment and energy recovery systems. Recent milestones include: - Inauguration of a 530 kWp photovoltaic system in 2024. - Installation of electric vehicle charging points.

- Initiation of a decarbonization analysis according to the Greenhouse Gas Protocol (GHG) criteria to identify areas for improvement. Sustainability isn’t just about corporate initiatives; it’s about employee engagement. We believe that our employees’ proactive actions can significantly amplify our efforts. We’re eagerly awaiting the results of our decarbonization analysis. These findings will guide our future sustainability goals and help us continue our journey of continuous improvement.

Join us at CPHI Milan 2024 to learn more about our commitment to sustainability.

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NEWS

Cambrex announces new liquid-phase peptide synthesis manufacturing technology

Cambrex, a leading global contract development and manufacturing

peptide synthesis processes. “Over the past several years, we have made significant investments in the research and development of complex synthetics, specifically

scaled in the same way as traditional small molecules.

organization (CDMO), today announced that Snapdragon

In addition to the LPPS, Cambrex developed unique capabilities in peptide and protein crystallization, including a crystallization screening platform specifically for the discovery of crystalline forms of peptides and proteins. Crystallization can deliver improved product quality and stability and reduce the need for time-consuming preparative chromatography and lyophilization. “With the clinical and commercial successes of peptide-based therapies, it’s imperative that we provide industry-leading solutions to develop and scale peptide candidates,” said Thomas Loewald, CEO at Cambrex. Cambrex will continue to invest in R&D across complex synthetic modalities, including further technology development for peptides, as well as new research on the application of artificial intelligence for the optimization of oligonucleotide processes.

Chemistry, a Cambrex company, has successfully developed a new liquid phase peptide synthesis (LPPS) technology that utilizes traditional active pharmaceutical ingredient (API) batch reactors and continuous flow, obviating the dependency on specialized, solid-phase reactors. This new LPPS technology materially reduces solvent demand and the need for excess reagents compared to standard solid-state

to reduce the economic and environmental impacts of manufacturing peptides and

oligonucleotides,” said Dr. Matt Bio, Chief Scientific Officer, Cambrex. “Our new LPPS technology provides a significantly more cost-efficient and environmentally sustainable solution when compared to traditional solid-phase peptide synthesis, substantially reducing solvent usage and allowing the substitution of sustainable solvents.”

The LPPS technology supports peptides up to 12 residues long, while larger peptides are then assembled in liquid phase, using a convergent fragment coupling approach. Processes developed with Cambrex’s LPPS technology can be

Agarose Bead Technologies expands facility to meet rising global demand for novel therapies market

Agarose Bead Technologies (ABT), a leading manufacturer of high quality agarose resins, proudly announces the completion of a major expansion at its facility located in Northern Spain, Burgos. The 1000 sqm addition positions ABT as one of Europe’s largest manufacturers

of agarose resins, strategically advancing its ability to meet the growing global demand for agarose resins in the pharmaceutical and bioprocessing industry.

and has increased its annual capacity to 100,000 liters of resins per year, enabling the firm to deliver larger scale orders. More storage space will be available to accommodate large volumes of products and ensure a robust and reliable supply chain for customers.

The Burgos site now boasts two new state-of-the-art cleanroom facilities

10 TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024

The expansion comes as ABT solidifies its commitment to supporting the growing needs of biopharmaceutical companies engaged in the development of novel therapies, such as monoclonal antibodies, vaccines, and cell and gene therapies. As these therapies require advanced purification processes, the demand for high quality agarose resins has surged, and ABT’s expanded capabilities aim to provide critical support to manufacturers worldwide. “Our investment in expanding the Burgos facility is a direct response to the increasing global demand for high-quality agarose resins,” said

Carolina Egea, CEO of Agarose Bead Technologies. “This enhanced capacity will enable us to meet the evolving needs of the pharmaceutical industry, improve supply chain reliability, and reinforce our role as a trusted partner in the development of life-saving therapies.” Egea continued: “In line with ABT’s dedication to sustainability and environmental responsibility, the new facility incorporates energy efficient systems and waste reduction strategies. The company continues to prioritise compliance with rigorous industry standards, ensuring that its products meet the highest levels of purity and

performance for biopharmaceutical applications.” The expansion of the new facility was completed in June 2024 and is now fully operational.

Lonza and Vertex sign a long-term commercial supply agreement for CASGEVY ® (exagamglogene autotemcel)

Daniel Palmacci, President, Cell & Gene, Lonza , commented: “It is a privilege to work with Vertex on bringing its innovative and cutting-edge medicines to patients suffering from life threatening diseases. We are also pleased to reach a significant milestone towards supporting the commercial manufacture

Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, announced the signature of a long-term commercial supply agreement for CASGEVY ® (exagamglogene autotemcel). CASGEVY ® is the first cell therapy based on the CRISPR/ Cas9 technology, discoverers of which were awarded the Nobel Prize in Chemistry in 2020. CASGEVY ® offers the potential of a one-time treatment for eligible patients with transfusion-dependent beta-thalassemia or sickle cell disease. Under the terms of the agreement, Vertex will leverage Lonza’s scientific, regulatory and manufacturing expertise, global manufacturing network, and first-hand experience in the commercial manufacture of cell therapy products. Lonza will manufacture CASGEVY ® at the state-of-the-art cGMP cell therapy manufacturing facilities in Geleen (NL), with plans to expand to its Portsmouth (US) facility. The Geleen (NL) cell manufacturing facility was recently granted a GMP license by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicines and Healthcare Products Regulatory Agency (MHRA). The Portsmouth (US) site is expected to begin GMP operations in 2025.

of CASGEVY ® by receiving the regulatory approval at our state-of-the-art cell therapy manufacturing site in Geleen.” Morrey Atkinson, Ph.D., Executive Vice President and Chief Technical Operations Officer, Head of Biopharmaceutical Sciences and Manufacturing Operations, Vertex , added:“Manufacturing a first-of its-kind therapy like CASGEVY ® is complex and requires advanced technology and capabilities. The Lonza team have been excellent partners as we have invested in our global manufacturing network to ensure CASGEVY ® will be available for the patients who need it. We look forward to our continued collaboration.”

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Renaissance Lakewood, LLC supports ARS Pharmaceuticals, Inc. ’s launch of world’s first nasal spray for life-threatening allergies

Renaissance Lakewood, LLC (“Renaissance”), a leading global contract development and manufacturing organization (“CDMO”) is proud to be manufacturing neffy ® , which is now commercially available in the US. On August 9, 2024, the U.S. Food and Drug Administration (“FDA”) approved ARS Pharmaceutical, Inc.’s new drug application for neffy 2mg (epinephrine nasal spray), the world’s first and only needle-free, intranasal spray treatment for Type I allergic reactions, including anaphylaxis in adults and children who weigh ≥30 kg (66 lbs.). neffy is the first and only needle-free treatment option for patients and caregivers living with severe (Type 1) allergic reactions. neffy is an easy-to-carry and easy-to-use epinephrine medication alternative to needle-based treatments. Type I allergic reactions are often caused by triggers such as allergies to certain foods, medications, or insect bites that can lead to potentially life-threatening anaphylaxis. neffy marks the first regulatory approval worldwide for epinephrine delivered as an intra-nasal spray. The six-year partnership between Renaissance and ARS Pharmaceuticals has involved every stage of development, from initial research and clinical trials to full-scale manufacturing and commercialization. By combining our manufacturing expertise with the expertise of ARS Pharmaceuticals, we have addressed the unmet medical need for alternative treatments for patients experiencing Type I allergic reactions, including anaphylaxis. The intra-nasal spray is designed for needle-free and rapid administration, allowing patients or caregivers to quickly deliver the medication at the first signs of an allergic reaction. Prompt administration of epinephrine is key to managing anaphylaxis.

Kimberly Ernst, Vice President, Product Development and Laboratory Services at Renaissance said: “Our partnership with ARS Pharmaceuticals has been crucial for the successful development and launch of neffy . We have helped ARS Pharma optimize the neffy formula and design a scalable manufacturing process, from early clinical stages to final registration and now to the first commercial batches. This program has included developing and validating analytical, spray and microbiological methods. In addition, the manufacturing process development employed quality-by-design principles to ensure robust and repeatable results.” Eric Kaneps, Vice President of Sales and Marketing added, “Renaissance offers unmatched pre commercialization support from development services to large-scale commercial manufacturing. Our proven track record makes us the CDMO partner of choice for any nasal program.” recently completed a campus expansion and had also previously invested in two additional packaging lines, which will support the forecasted volumes for this important product while assuring ample capacity for other nasal sprays manufactured at Renaissance. Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharmaceuticals, added: “We appreciate the excellent support provided by Renaissance throughout the development of neffy and their diligence in meeting our launch timing for the U.S. market. We were thrilled to make neffy available to patients across the country earlier this week and have great confidence in Renaissance to reliably supply neffy worldwide.” To ensure the capacity to quickly respond to growing global market demands, Renaissance

NEWS

Nutriband licenses Bitrex ® brand aversive agent for its lead product – AVERSA™ fentanyl trandsdermal patch

Nutriband Inc. a company engaged in the development of prescription transdermal pharmaceutical products, announced that it has signed a trademark licensing agreement for the use of Bitrex ® brand denatonium benzoate as an aversive agent in its lead product, AVERSA™ Fentanyl, an abuse deterrent fentanyl patch. Nutriband’s AVERSA™ abuse deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl while making sure that these drugs remain accessible to those patients who really need them. According to the FDA [1] , accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a

sticking the patches on their skin. This can cause death by slowing the child’s breathing and decreasing the levels of oxygen in their blood. Nutriband abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products. Preliminary studies have shown that the coating is very difficult to scrape off and the technology has a patented immediate and extended-release profile which presents an additional layer of deterrence to prevent the aversive layer from easily being washed off in an attempt to separate the drug from the aversive agents. Bitrex is the brand name for denatonium benzoate, the most bitter substance in the world. The extremely bitter taste makes products taste so bad that it makes children and adults who put them in their mouth want to spit them out immediately. This reaction is the body’s natural response to bitter tastes, which has evolved over millions of years to help protect us from eating foods or materials which may be harmful. Children are particularly sensitive to bitter tastes which is why Bitrex is so effective at helping prevent accidental ingestion and poisonings in young children. Bitrex has been proven to be safe and effective in

many products including household cleaners, pesticides, automotive products, laundry detergent, pens, paint, and batteries that are approved and sold all over the world. Nutriband is currently working with its partner Kindeva Drug Delivery (Kindeva), a leading global contract development and manufacturing organization focused on drug-device combination products, to develop the commercial scale manufacturing process to incorporate Nutriband’s AVERSA™ abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system. AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million [2] . 1. https://www.fda.gov/consumers/ consumer-updates/accidental exposures-fentanyl-patches continue-be-deadly-children 2. Health Advances Aversa Fentanyl market analysis report 2022 - Bitrex ® is a registered trademark of Macfarlan Smith Limited (a Veranova company). References

powerful opioid pain reliever. Children can overdose on new and used fentanyl patches by putting them in their mouth or

NEWS

Formulated Solutions adds third GMP aerosol line to deliver fill flexibility, accelerate delivery timelines, and increase production capacity

Formulated Solutions, a contract development and manufacturing organization (CDMO) focused on innovative pharma and consumer healthcare solutions has added a third GMP aerosol production line as it prepares for future customer demand. Featuring the latest cutting edge technology, the new GMP production line at its Cleveland facility is fully automated from filling through to final case packing. The new high speed line leverages a mass flow filler to deliver exceptional fill accuracy, automated leak detection to ensure high levels of compliance with the US Department of Transport’s (DOT) aerosol regulations, and fully automated secondary bundling in support of the demands of retail channel distribution. The ability to now run three distinct product lines significantly boosts the company’s production capacity for medicated topical aerosols, including sunscreens, topical analgesics, anti fungal sprays, and more. With the aerosol packaging market estimated to be worth $7.5 billion this year, and projected to grow at a CAGR of 5.0% to 2032, Formulated Solutions’ new line positions it to effectively meet future demand, from initial concept to full-scale

manufacturing. Scott Carpenter,

VP of Marketing & Partner Innovation, Formulated Solutions said: “As consumer and retailer interactions with key market products change, companies are faced with the challenge to innovate, cut costs, and

accelerate delivery at the same time as maintaining strict quality and safety standards. “Innovation and quality are embedded in our core values at Formulated Solutions. The

line includes: -

Fully automated button/ actuator tipping Placement of overcaps and tamper evident neck band capabilities Fully integrated automated case packing Advanced leak detection Optical character recognition verification to ensure text codes contain product information for tracking aerosols through the supply chain and inventory management are correct and legible. Formulated Solutions also supports the production of over the counter (OTC) medicines, NDA drugs, medical devices, consumer healthcare topicals, nasal sprays, and oral dose liquids. - - - -

addition of a second GMP aerosol production line at our Cleveland facility, our third full scale line in our production network, will ensure we have the flexibility and capacity to deliver on demand for services in this thriving sector, and will help us continue to meet our industry leading quality standards.” The new line’s functionality allows Formulated Solutions to offer customers the capability to fill two different bulk intermediates sequentially and use two different propellant blends in the same finished product. Cutting-edge technology featured in the new

NEWS

PROCOS S.P.A. continues to expand: updates about recent investments & technology

PROCOS S.P.A., announced its progress on the expansion of its current cGMP manufacturing facility with the addition of a new building named R11. This state-of-the-art building, which will be fully commissioned in 2 phases, is ready for the installation of equipment for Phase I, which has a total investment of 65M Euro. R11 represents PROCOS’ significant organic growth in the small molecule CDMO sector as this new building will house 4 multipurpose lines focusing on small scale volumes with approximately 20, 1000 – 6000L reactors, 4 centrifuges and

additional drying capacity with the intention to support low volume, high value complex molecules and Clinical Phase I/II/III materials. This Phase I investment is expected to add another 73 cubic meters of manufacturing capacity. The equipment installation is ongoing, and qualification is expected in 2025, with approval and launch in 2026. “Our global partners have expressed sincere excitement about the new R11 building, especially when they have the opportunity to see the progress while visiting PROCOS on-site. It is amazing the draw for the small-scale volume capacity needs

because of the increased number of NCE programs PROCOS is engaged in are for rare disease or more complex molecules, compared to the past,” said Simone Manzini, Business Development Manager, Custom Synthesis. PROCOS continues to map out Phase II of this expansion which should include 15 reactors, 3 centrifuges and other unique drying capabilities. In total, at the completion of Phase I and Phase II, PROCOS anticipates a total capacity increase of 25%, reaching total output of over 700 cubic meters and upwards of 350 metric tons of total API output in the future.

VERANOVA

Veranova is a global leader in process development and manufacturing of APIs, with a focus on specialty and complex products. The headquarters of Veranova is in Wayne, Pennsylvania, and it has operations in North America and Europe. Strategic partnerships between pharmaceutical and biotech companies and CDMOs are becoming increasingly critical for developers to deliver timely, accessible and affordable medicines. This evolving relationship is transforming the pharmaceutical industry across several key areas, creating faster drug development for businesses and better outcomes for patients. Over the past decade, the industry has made remarkable progress in shortening drug development timelines. While speed is important, it must never compromise patient safety or regulatory compliance. CDMOs can streamline drug development timelines by employing advanced Accelerating fast-to-market strategies

process development and optimisation techniques. By adopting cutting-edge technologies, CDMOs can shorten the journey from lab to clinic, lower costs and speed time-to-market. A notable example is Veranova’s May, 2024, partnership with Phorum.AI, which leverages artificial intelligence (AI) to optimise pharmaceutical manufacturing. By combining Veranova’s extensive datasets with Phorum.AI’s computational chemistry engine, this collaboration aims to enhance process efficiency, reduce costs and boost environmental sustainability. The pharmaceutical pipeline is shifting toward more complex and potent molecules designed for targeted, patient-specific therapies. These include antibody-drug conjugates (ADCs), protein degraders, peptides and RNA-based therapies. While these innovations hold immense promise, they also present new processing challenges due to their potency and more complex molecular structures compared to traditional small molecules. Innovating in therapeutic modalities

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CDMOs are meeting these challenges by offering a range of processing technologies, such as isolation and purification, and investment in potent handling infrastructure and expertise for handling ADCs and other highly potent APIs. ADCs have emerged as a ground-breaking therapeutic modality, specifically in oncology, by combining the targeting precision of antibodies with the potent effects of cytotoxic drugs. ADCs provide an effective treatment option, with fewer side effects, and Veranova is proud to be a key supplier of ADC linker-payloads for products in clinical development and on the market. Understanding the growing demand for ADC expertise, Veranova has made

A skilled CDMO streamlines the complexities of technology transfer, often making the difference between seamless collaboration and critical supply chain failure. Veranova is committed to building resilient supply chains that empower its customers to navigate global challenges with confidence. Looking ahead, CDMOs will continue to be at the forefront of pharmaceutical innovation, driving technological advancements and forging strategic partnerships. The collaboration between pharmaceutical companies and CDMOs The future of CDMOs

substantial investments in expanding the company’s ADC capabilities, including a $30 million expansion of the Devens, Massachusetts, facility, to enhance its ability to manage these complex molecules safely and efficiently.

will be essential for harnessing digital tools and AI to enhance efficiency and reduce development costs.

Veranova’s core values – People, Patients and Innovation – are at the heart of everything it does. The company is committed to developing top talent, as demonstrated by its recent leadership appointments, and it continually invests in cutting edge capabilities to meet the evolving needs of the pharmaceutical landscape. Together with its partners, Veranova is shaping the future of pharmaceutical development, driving innovation and ultimately delivering life-changing medicines to patients worldwide.

Strengthening supply chain resilience

The global pandemic exposed vulnerabilities in pharmaceutical supply chains, which has increased interest in establishing onshore development and production to strengthen security and improve co ordination. Continuing geopolitical risks have led many companies to develop contingency strategies through domestic partners that will ensure a stable supply chain to meet patient needs. By partnering with CDMOs, biotech companies gain access to additional manufacturing capacity and expertise. This facilitates production scaling and guarantees a reliable supply chain, especially for high demand molecules or those requiring accelerated production. CDMOs also provide flexibility, acting as alternate vendors to mitigate risks and ensure consistent product availability for patients.

MIKE RILEY Chief Executive Officer Veranova

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CORDENPHARMA

CordenPharma’s 2024 investments and global platform approach to CDMO development and commercialisation support pharma innovators to address their drug lifecycle gaps and reach patients faster.

CordenPharma provides CDMO services that elevate pharma and biotech customers to support complex modalities across the drug development spectrum. By aligning our facilities and technology platforms to anticipate the challenges innovators often encounter as they work through development phases towards commercial markets and patients, CordenPharma offers bespoke end-to-end services designed to promote the rapid scale-up of pre-clinical, clinical and commercial manufacturing capabilities, and the latest technology to accelerate development of today’s most advanced large and small-molecule therapeutics. With our fully-integrated supply model as an overarching focus, CordenPharma has made recent, significant investments across all six technology platforms (Peptides, Oligonucleotides,

expansion initiatives occurring in parallel in the US and Europe, including both existing facilities and new constructions designed and built according to the pharmaceutical industry’s most stringent quality and technical standards for short and long peptide manufacturing, including Biologics License Applications (BLA) requirements. The US expansion involves bringing additional Peptide capacity to our CordenPharma Colorado site with the planned construction of a new large-scale manufacturing facility and an additional increase in manufacturing trains in the existing facility.

Injectables, Lipids & Carbohydrates, Highly Potent & Oncology and Small Molecules).

On 16 July, 2024, we announced our largest strategic investment to date to grow our Peptide technology platform with a committed spend of ~€900m over the next three years. These transformational plans consist of two major

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Through this integrated peptide-injectable offer, customers will benefit from: - One CDMO relationship with a single contract, including quality agreement and project management. - API route selection, salt and solubility studies, API characterisation, reference standard qualification (RABS). - Formulation development, analytical method development and validation (27.9m 2 , 15 shelves). - Technical writing for the IND/IMPD submission.

Peptide platform receives record

investment for expansions in small to large scale peptide production.

This is the result of rapidly increasing demand in the Diabetes and Obesity Glucagon-like Peptide 1 (GLP-1) agonist medications market and comes off the back of multiple, long-term, multi-year contracts totalling ~€3 billion, with potential upsides. The European expansion centres on the construction of a new state-of-the-art greenfield facility in Switzerland, with the aim of creating additional Peptide capacity to serve customers from initial early clinical to late-stage commercial manufacturing. The new site will be fully integrated within CordenPharma’s existing facility network. In addition to enhanced large-scale manufacturing, our multi-pronged approach to becoming the #1 peptide CDMO supplier extends to small-scale capabilities at our Peptide Centre of Excellence in Frankfurt, Germany, with the commissioning of new GMP capacities to manufacture early clinical phase peptide APIs for pharma and biotech customers. The investment will be fully operational and authorised by German authorities in Q4 of 2024. The Frankfurt site will add 1000 m 2 of manufacturing space, including two fully equipped lines comprised of a Solid Phase Peptide Synthesizer (SPPS), High Pressure Liquid Chromatography (HPLC), Liquid Phase (LP), isolation equipment and quality control laboratories, including In Process Control (IPC), starting material batch release and GMP stabilities. The GMP manufacturing area is designed to produce peptide APIs from gram to kilogram range for clinical phase 1 and 2 requirements. Moreover, the GMP expansion supports the launch of an integrated service offering between CordenPharma Frankfurt (for Peptide Drug Substance) and CordenPharma Caponago, Italy, (for Injectable Drug Products) to deliver fully customisable technical, manufacturing and regulatory support that is specifically targeted to enable efficient IND/IMPD filings, with all the necessary materials needed to initiate customers’ First-In-Human (FIH) clinical trials.

Oligonucleotide platform addresses largest gaps in oligo market.

After an initial exit of the oligo market in 2018 due to shifting CapEx investments, CordenPharma was pleased to announce in 2023 that we have re-entered the oligonucleotide manufacturing space with an initial ~$25 million budget in two phases, backed by record year-over-year sales growth and reinforced with new Private Equity owners Astorg and scientific strategies to support innovative, complex modalities. Phase one of the program, the reconditioning of existing laboratory space, purchase of development equipment and the hiring of an expert team to set up process and analytical development capabilities, was successfully completed in the Summer of 2024. Phase two includes the redesign of existing manufacturing space to create a fully GMP-compliant manufacturing area housing synthesis, cleavage, downstream processing and lyophilisation at 10-160 mmol scale. These manufacturing assets will provide early to mid phase clinical trial supply for customer demands and are envisioned to come on stream in mid-2026. Future expansions are being investigated to cover increased capacity and scale capability strategically designed to supply customers with validation and commercial supply solutions to address the largest gaps in the oligonucleotide market. As a stand-alone service offering for customers in the early clinical phases, we believe this two-phased approach will have great benefit. However, when taken in combination with our recently-expanded sterile injectable filling capability, full Lipid NanoParticle (LNP) formulation development and manufacturing services,

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