24/7 BIOPHARMA - issue 1 / October 2024

CORDENPHARMA

[CordenPharma Photo] - Organic phase (ATXEX) LNP preparation room.

The 900 m 2 area, which is Grade C throughout, is now ready for fully scalable clinical and commercial manufacture of cGMP LNPs. Furthermore, the FDA and EMA-approved site already offers clinical and commercial Fill Finish into Vials and PFS and benefits from having over 30 years of sterile manufacturing expertise. Full integration allows for LNP formulation and process development at the same site and a wide variety of catalogue and custom Lipid manufacture, along with nucleic acid manufacture within the CordenPharma network and through our partnership with Wacker. The cGMP LNP suite consists of four main areas: 1. Weighing and dispensing of lipids, salts and other excipients under a laminar airflow hood (LAF) connected to a state-of-the-art SCADA system. 2. Aqueous buffer preparation room consists of 4 x 000L compounding stations. All aqueous buffers are prepared and filtered for bioburden reduction and are used for LNPs, dilution buffers, priming of TFF filter membranes and diafiltration. 3. LNP assembly room is ATEX-certified and contains four stainless steel vessels, each with a 30 kg capacity for preparing organic phases, which typically comprise of lipids dissolved in absolute ethanol. This organic phase system is highly automated and offers Clean In Place (CIP) and Sterilisation In Place (SIP). In the same room, the nucleic acid containing aqueous phase is prepared and a bioburden reducing filtration in also performed. A choice of 2 LNP assembly systems are available; Impingement Jets Mixing (Knauer) and NxGen Microfluidics (Cytiva). 4. Lastly, our purification room is dedicated to LNP purification and concentration through

Video highlighting CordenPharma’s Lipid NanoParticle (LNP) GMP manufacturing from clinical to commercial supply.

ultrafiltration and diafiltration using a disposable TFF system (Repligen KTF 1600 TFF), which is specifically designed to reduce shear on LNPs and to accommodate a wide variety of batch sizes from a few litres to several hundred litres. Finally, Fill & Finish into vials or Pre-Filled Syringes (PFS) is offered in the same building, reducing risk and accelerating timelines. Because Oral Solid Dose (OSD) capabilities are in high demand, CordenPharma made the strategic decision to enhance our offering with an investment of €9.7 million into the design and installation of a new Clinical Trial Development (CTD 4) facility located in CordenPharma Plankstadt. From early stage lot development to clinical supply-scale process, Plankstadt has become CordenPharma’s Drug Product Innovation Centre of Excellence for the development and manufacturing of highly potent OSD products for compounds with OEL levels as low as < 1 µg/m 3 . Set to be qualified in late 2024, the facility investment came about in response to drug developers’ need for capabilities that specifically address issues of scale and process in early phase clinical supply. Focused on the formulation challenges often troubling insoluble APIs,

23 TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024