24/7 BIOPHARMA - issue 1 / October 2024

LONZA

for established APIs where an improved synthesis would be beneficial for commercial reasons. The potential cost savings are another important factor. Drug developers and manufacturers will clearly feel the economic benefits of faster and more cost-effective syntheses, and tools like these can have significant financial benefits. These can also be passed on to patients and health authorities through lower drug product prices. It can also be a game-changer for small biotechs. These companies are reliant on hitting milestones for securing the funding they need to progress their investigational drugs through the different stages of development. Anything that can assist in moving the product through the pipeline as quickly as possible will clearly help bring those important milestone payments closer. Retrosynthetic analysis has advanced dramatically since those early days in Corey’s lab at Harvard. Modern CASP tools relying on big data have enhanced its power and now underpin the process of finding good potential synthetic routes. By combining CASP technology with real-world market intelligence, Lonza can find the best ways to make individual molecules as quickly and cost effectively as possible, accelerating their pathway into the clinic and to the patients who need them.

The next step involves human input from Lonza process R&D experts. Their experience allows them to rank potential reactions on their synthetic viability and determine when they might expect to see challenges. Ultimately, they will identify a route that ticks all the boxes. The top-ranked route should balance commercial and synthetic viability. Data about the commercial supply chain is key to determining the commercial viability of the various potential routes. Pricing is only part of the story; it also covers the global supply situation for each required chemical, including who makes and sells them and total global production volumes. Manufacturing decisions can then be made informed by real-world data, as publicly available pricing data may be misleading and does not indicate availability. Combined with the sophisticated tools used to pinpoint potential synthetic routes, optimised routes that are less likely to face complications during scale-up can be identified at the outset. There are, of course, multiple further benefits to this approach. What might look like the best option because it has the fewest steps may prove problematic from a logistical perspective or more require more costly building blocks. Lonza’s AI-enabled Route Scouting service assists in creating a right-first time approach, greatly reducing the likelihood that the route will have to be altered later in the light of sourcing issues. This is equally valid for new chemical entities and Supply chain insights

28 TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024