The commercial canyon in biopharmaceutical early development can be found between the laboratory bench and clinical trials; however, with a consolidated approach, firms both small and large can bridge the gap. Adopting Patheon's four key strategies can make a difference.
Patheon has spent 30 years providing contract dosage-form development and manufacturing services to the pharmaceutical industry. It follows four key strategies that help build success into biopharmaceuticals.
Face today's challenges without creating new ones After years developing a biologic, it is often jarring to shift gears into the development of the pharmaceutical product. New challenges your team will face include inherent instability, light and temperature sensitivity, and cold chain logistics.
Meanwhile, business pressure to get the product through clinical trials and out to market is immense.
Pragmatic choices need to be made about highly complex science to obtain a suitable formulation quickly. These choices have the potential to take time and cost a lot of money. What you need is expert advice, so it is wise to engage your centralised data management office (CDMO) early. While you want to be efficient, you need to know that you can manufacture what you develop and safely administer it to patients in clinical trials.
The goal is to find the best way to take what you have in the lab and deliver it intact to patients. To accomplish this you must explore as many suitable formulation options as time and budgets allow. No single analytical technique is capable of measuring all of the different types of degradation to which a biopharmaceutical is susceptible.
Find a CDMO that offers a broad range of options. Ideally they'll have the capability to design an early formulation that can change between liquid or lyophilisation. They should also be able to manufacture at an appropriate scale to meet clinical test material requirements. And if they offer multiple fill/finish options, better still. Make sure you give your molecule the broadest range of options to enable it to become a viable product, and don't be limited by a contractor with limited offerings.
Formulation, analytical development and process design are so interrelated that it makes sense to consolidate them under one roof as much as possible. Transferring methods and processes from one contractor to another often causes costly delays and redundant revalidations.
Potential pitfalls include additional steps (and missteps) in communication, untimely response from former vendors, and differences in equipment; for example, cell-based assays are notorious for behaving in unexpected ways in different laboratories. By adopting a consolidated approach with a single CDMO, you'll be better able to optimise the timing, achieve smooth transitions from one stage to the next, establish streamlined channels for providing feedback and addressing concerns before they become problems, and maximise limited quantities of highly expensive early-stage biologic material. Team continuity is crucial. Having the same people working on various stages of your project will preserve knowledge and experience of complex methods. You also get to maintain momentum and build interpersonal relationships - the most difficult chemistry of all to master. The bottom line: when you minimise transfers, you minimise risk.
You should partner with an experienced CDMO in order to benefit from their scientific expertise and for the depth of their existing organisational capabilities and resources. A contractor with auditing preparedness, systematic record-keeping, and a stellar regulatory track record can help you avoid unnecessary delays. A CDMO with a broad client base typically demonstrates a broad array of in-house capabilities to satisfy the needs of your product. It also indicates the organisation has the equipment to produce clinical test materials in appropriate quantities and to seamlessly scale up manufacturing.
A contractor that is financially stable will be around to complete the development cycle, and if your product is a commercial success, they will have the means to scale up to meet commercial demand and support you over the long haul.
Not only is an experienced CDMO best able to help you bridge the gap from early development to formulation, the chances are it already has that bridge built and waiting