Issue link: https://www.e-digitaleditions.com/i/1499694
www.biopharminternational.com Partnerships for Outsourcing eBook May 2023 BioPharm International ® 5 Industry trends nanoparticles, which are used in mRNA formulations, have received a similar boost in popularity among out- sourcing companies such as CordenPharma, who sig- nificantly expanded their LNP capabilities in 2022 (6). "With the success of the Moderna and Pfizer COVID vaccines, LNPs [lipid nanoparticles] vaunted to the front of the pharmaceutical arsenal," said Stephen Houldsworth, vice-president and head of Platform Management & Marketing at CordenPharma, in an interview with Pharmaceutical Technology® (7). "We're looking to take advantage of that with our customers that are looking to develop their medications in an LNP format and help them through development and also into commercial manufacturing." However, mRNA is not the only field benefitting from the inf lux of interest in biologics. In a candid inter v iew w it h Phar maceutical Technology at t h is year's Drug, Chemical & Associated Technologies Association conference, Gregor Kawaletz, head of the Oral Solid Dosage Business Unit at Recipharm, high- lighted how three recent acquisitions made by Reci- pharm—both GenIBet and ArrantaBio in February 2022, as well as Vibalogics in April 2022—were made in part to expand the company's biologics knowledge for use in oral biologics (8). "The small-molecule analytical methods are very dif- ferent to biological analytical methods," said Kawaletz. "Since we made some acquisitions in the biological area with Arranta Bio, Vibalogics, and GenIbet, we inherit the know-how to analyze these biological products to get the right results. By using this know-how with our oral capa- bilities, it is a kind of wonderful synergy effect, allowing us to use the best from those areas." Per Kawaletz, oral biologics have long been viewed as a holy grail in pharma, as it is notably difficult to orally deliver large molecule products due to their size and susceptibility to stomach acid. However, in that same interview, Kawaletz stated that Recipharm is expecting the first oral biologic out of its GenIBet facility in 2024. Shou ld t h is happen on t hat t imeline, it wou ld transformationally impact the landscape for bio- logics. While pharma is an industry that is known for slow change, a breakthrough of this magnitude adds a new dimension to large molecule delivery and would almost certainly incite a dramatic increase in popularity. Consider, for instance, the impact of an insulin pill—millions of people with diabetes looking to avoid daily injections would immediately repre- sent massive market demand. In addition to the therapeutic merits of existing biologic products, oral biologics shine a light onto the efforts being made by other companies to ramp up their biologics production. If this technology be- comes commonplace, its entirely possible to forsee a future where biologics capture a significantly larger share of the market. Preparing for that momentum shif t in advance, regardless of whether one is ex- ploring oral biologics specifically, could be crucial in maintaining relevance. End-to-end integration When asked in an interview with Pharmaceutical Tech- nology what her prediction about the future of pharma would be, Sarah Stevens, senior vice-president and head of Drug Product Development & Manufacturing at Quo- tient Sciences, had an interesting perspective (9). "Thinking about it from the CDMO [contract devel- opment and manufacturing organization] and phar- maceutical services perspective, I think we will see this continuing direction of travel towards offering a fully integrated end-to-end service," said Stevens. "I think almost all CDMOs will be at least claiming to offer integrated, end-to-end services." On its surface, Stevens' comments may not seem to be a particularly striking take, as end-to-end ser- vice is one of the premiere marketing terms used by outsourcing companies looking to catch the eye of would-be clients. However, the growing popularity of true end-to-end integration—from research to com- mercial manufacturing—hints at the supply chain issues that continue to plague the post-COVID phar- maceutical industry. "I think that, in very general terms, that COVID has brought an acute focus to the supply chain," said Ste- vens in the interview. "And again, it's all about plan- ning, and maybe 'just in time' isn't the right approach, and maybe it's thinking more carefully about fore- casts, from a commercial manufacturing perspective, and just the materials management part of any busi- ness where you're dealing with businesses in CDMO spaces. I think we've got the attention that has been needed, and brought acute focus and a much clearer view. Planning has become all the more important." Following the onset of the global pandemic, the just- in-time supply model was significantly challenged, and many have since called for onshoring and in- creased centralization of the supply chain. For small- to-mid size pharma companies, the types of entities that are reliant on outsourcing companies, consolidat- ing into one partner enables them to focus their efforts and provide logistical support. Large companies may also see benefits in this re- gard. Sanofi (10), Regneron (11), and Gilead (12) are just a handful of big pharma companies who have entered drug discovery collaborations worth over a billion dol- lars in the past year. If these big money drug discovery partnerships continue to occur at this rate, simplifying the process by bringing in a CDMO who can help prior to manufacturing could, if planned and implemented properly, save time, effort, and money. "The cost of transfers and the loss of time in trans- fers from one company to another, from one partner