PHARMACEUTICALS
Small is still beautiful
Andy Anderson , APIs & Intermediates lead at Pfizer CentreOne , looks at the prospects for small molecule APIs
When asked where they see
the future of small molecule heading , the go-to position for industry commentators during the biologic drug molecule boom of the past decade has been that ‘ Traditional small molecules are dead ’. This could not be further from the truth . Traditional small molecules will continue to be the primary modality used for delivering medicines to patients around the world for the foreseeable future and the majority of FDA approvals in recent times continue to be for small molecule compounds . This is an exciting time for new technologies and modalities where potent , targeted small molecules are used in novel ways in combination with biologics . The equipment , technology and skill required to manufacture these compounds will be significantly more complex than those for traditional small molecules . Future therapies that bring together classical biologic and small molecule modalities with next generation molecular conjugates will drive the companies developing them to seek out partners with a greater breadth of development and manufacturing capabilities . How a future increase of biologic drug production could affect the market depends on the specific molecules and technologies required to manufacture them . If we look at a macro level , there has been a huge rush of capital into the classic biologic CMO space in the past decade , to the point where we now have overcapacity from an industry perspective . We can expect to see further consolidation of this capacity and innovative partnership models between various players in the market to meet this demand . Where the capacity is located will also become an important factor . We are seeing the same story play out with next generation biologic therapies right now : a rich pipeline , under installed capacity , a flood of capital into the space by multiple players . Over time , market forces will result in over installed capacity with an eventual return to equilibrium between installed capacity and demand . Pfizer CentreOne itself is seeking to maintain itself at the forefront of the industry . Most obviously , we have invested more than $ 1 billion in the past ten years into our flagship facility for small molecule API contract development and manufacturing in Kalamazoo , Michigan . This is the largest site in the Pfizer network and of its kind in the US , and we plan further investment over the next five years . This commitment to investment ensures that our technologies and capabilities are continually expanding and improving so we remain at the forefront of small molecule manufacturing . Alongside this , we are focus on attracting and retaining talent to build on our base across multiple disciplines at the site . This expertise is evidenced by the recent launch of the first molecule from our greenchemistry programme , Enviero progesterone , which was developed at Kalamazoo . This results in a 70 % reduction in carbon footprint compared to the traditional process and removes all metal catalysts . •
Andy Anderson
APIS & INTERMEDIATES LEAD
J j
Anderson – Still a strong future for small molecules
JAN / FEB 2021