Lonza's Conrad Roten and David Lyon explain why integrated drug substance and drug product services can help shorten First-In-Human (FIH) trial and drug commercialisation timelines.
Key highlights:
- Small biopharma companies face challenges when developing small molecule-based therapeutics due to a lack of resources and facilities.
- CDMOs have become key in overcoming these barriers by eliminating the need for technology transfers as well as the risks of multiple contracts, mechanisms and protocols.
- A study by Tufts found that by partnering with a single CDMO, biomanufacturers could shorten timelines by an average of 14 weeks and reduce costs by almost $21 million.
- CDMO partners should have expertise in bioavailability enhancement technologies and be able to select and supply drug candidates to accelerate the development pathway.
- Biopharma companies should ensure that their CDMO has the appropriate containment facilities to safely manufacture potent products at scale.
The complexity of today’s growing pharmaceutical market is driven by a wide range of trends, such as the rise of highly potent molecules and specialised drugs, accelerated timelines, and uncertain market demand, all of which are putting new pressure on biopharma companies as they face a host of unique manufacturing challenges on the path to market.