Issue link: https://www.e-digitaleditions.com/i/1450659
26 Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 P h a r mTe c h . c o m The ac tions t aken by cont r ac t development and manu f ac tur ing organizations (CDMOs) and contract research organizations (CROs), large or small, provide insight into the greater state of the biopharmaceutical industry. Recent news surrounding CDMOs prioritizing mRNA services, full- service integration, and global expansion may provide context to the state of outsourcing. Full-service integration Piramal Pharma Limited (PPL) increased its stake in Yapan Bio, an India- based biologic s manufac turer, with an investment of approximately US$13.7 million (€11.95 million), which was announceed in December of 2021. Yapan Bio works with various complex biologics, including current good manu f ac tur ing prac tice (CGMP)- compliant manu f ac tur ing of vaccines and biotherapeutics. This includes high-containment classes up to biosafet y level-2, recombinant vaccines, both RNA and DNA vaccines, gene therapies, monoclonal antibodies, and therapeutic proteins. According to a company press release, PPL made this move in an ef for t to augment their antibody-drug conjugation capabilities. Peter DeYoung, CEO of Pharma Solutions at PPL, noted in the press release that biologics (and their accompanying development ser vices) are the fastest growing segment s of the CDMO business. Integrating biologic s into their of ferings allows CDMOs to provide a full suite of ser vices, including development, manufac turing, conjugation, and f ill/f inish (1). This news touches on a key trend among CDMOs: the desire to provide an all- encompassing ser vice. For ins t ance, in June of 2021, thre e companies—Protagen Protein Ser vices, BioAnaly tix, and GeneWerk— agreed to a merger. In Januar y of 2022, the newly formed company, ProtoGene, announced that they would supply "advanced, integrated, an d co m p le te p r otei n an d g e n e anal y t ic s e r v ice s f o r b i o lo g ic al therapeutics and cell and gene therapy plat forms" (2). Other CDMOs, such as the recently formed ten23 health, have also allocated resources toward providing an integrated of fering (3). Still other CDMOs that have existing end-to-end ser vice capabilities, such as Curia (4) and WuXi Biologics (5), are making it a point to highlight the end-to-end ser vice aspec t of their business struc ture. Industr y demands are put ting pressure on CDMOs for more comprehensive ser vices. The increase in demand can be at tributed to various fac tors, such as the COVID-19 pandemic, which caused severe supply chain disruptions. The s e disr uptions highlighte d the idea that wor k ing w i th a f ull- ser vice company for pharmaceutical needs may be more prudent. But independent of "why", the "what " of this trend may be showing how successful CDMOs will need to operate in the future. The shift toward mRNA Merck KGaA announced in Januar y that they would spend US$780 million (€ 680.81 million) to acquire E xelead, an Indianapolis-based CDMO specializing in complex injec table formulations. These include both lipid nanopar ticle (LNP)-based drug deliver y technology, as well as f ill/f inish capabilities. According to Belén Garijo, CEO of Merck KGaA, Exelead was purchased be c ause of the company 's complement ar y abilitie s as it concer ns messenger RNA (mRNA) deliver y ser vices. mRNA therapies have received a well- documented boom in interest following the release of mRNA- based vaccines for the SARS- CoV-2 virus. In a press release detailing the acquisition, Gar ijo s t ated that Merck felt that the acquisition would allow the company to pounce on this fast-growing market for mRNA therapies (6). Merck 's US$780 million (€680.81 million) move may foreshadow an increased prominence on mRNA in the industr y. In addition to Merck 's acquisition, indus tr y powerhouses such as Lonz a (7) and Samsung Biologic s (8) have both ramped up their presence in mRNA over the course of the past year, suggesting a strong trend toward mRNA. CDMOs are being rewarded for put ting signif icant sums of money into mRNA, an indication that mRNA deliver y mechanisms will likely continue to grow in prominence in the biopharmaceutical space. Global expansion efforts In August of 2021, BioAgily tix, a US-based CRO, announced that it would be acquiring 360biolabs, a CRO based in Australia. While this added immunology and virology services to an organization known for specializing in large molecules, Jim Datin, president and CEO of BioAgilytix, stated in a company press release that this move was made as part of the company's global growth strategy to reach more markets (9). The acquisition of 360biolabs allowed BioAgily tix to expand its human testing ser vices into Australia. Similarly, ten23 health's acquisition of SwissFillion not only gave it that company 's capabilities in f ill/f inish ser vices, but regulator y approval to do so for both the US and European markets (3). The supply-chain disruptions brought on by COVID-19 may have made it dif f icult for customers to source multiple companies for dif ferent par ts of the pharmaceutical process. However, these limitations also held true for CDMOs: if a company does not have a global presence while the global economy is strained by a pandemic, it will have some dif f icult y accessing cer tain market s. By acquiring a company that can direc tly inter face with that region of the world, a company can organically grow their overall presence. References 1. PPL, "Piramal Pharma Ltd. To Invest Minority Stake in Yapan Bio, India- Based CDMO Providing Exper tise in Biologics and Vaccines," Press Release, 21 Dec. 2021. 2. BioPharm International, " Protagen Protein Ser vices, BioAnaly tix , a n d G e n e W e r k C o m b i n e t o F o r m N e w C R O , P r o t a G e n e , " Biopharminternational.com, 18 Jan. 2021. 3. ten23 Health, "Swissf illon, a Leader in Sterile Filling of Complex Pharmaceuticals, Joins ten23 health and Enhances the Combined Company 's Inte grate d O f fering to It s Customer s," Press Release, 25 Oct. 2021. 4. Curia "About Us," curiaglobal.com, accessed 27 Jan. 2022. 5. WuXi Biologics, "Company," wuxibiologics.com, accessed 27 Jan. 2022. 6. Merck KGaA, "Definitive Agreement to Acquire Exelead will Strengthen the CDMO Of fering for mRNA of the Life Science Business of Merck KGaA, Darmstadt, Germany," Press Release, 6 Jan. 2022. 7. Lonza, "Lonza and Moderna Enter New Agreement to Double Drug Substance Production for COVID -19 Vaccine in Visp," Press Release, 29 Apr. 2021. 8. Samsung Biologics, "Samsung Biologics Shares Strategic Roadmap for Sustainable Grow th at the 40th Annual JP Morgan Healthcare Conference," Press Release, 13 Jan. 2022. 9. PR NewsWire, " BioAgily tix Closes Acquisition of Australia - base d 360biolabs," Press Release, 14 Oct. 2021. —Grant Playter Contract, Development, Action! Analyzing Recent Events in Outsourcing Development