BioPharm International - May 2022

BioPharm International- May 2022

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34 BioPharm International May 2022 eBook www.biopharminternational.com completed as soon possible so that t h e y c o u l d c o m m e n c e c on s u m e r programs in 2022 (2). Similarly, Recipharm dove headfirst into the biologics market with their acquisition of various biologics-based CMDOs. It began on Feb. 1, 2022 when they announced their acquisi- tion of GenIbet, a Portuguese CDMO specializing in the manufacture of bio- logical clinical trial material and novel modalities like viral vectors, RNA, and microbiome (3). This would be of some interest alone, but the company went on to triple down later that month by acquiring two other biologics CDMOs on the same day : Viba log ics and Arranta Bio. Like Genlbet, Vibalogics specialized in various forms of virother- apy (4), whereas Arranta Bio was more focused on microbiome therapeutic products and mRNA clinical produc- tion capabilities (5). T h is i ntere st is u nsu r pr isi ng— mRNA therapeutics were growing in prominence before their use in major COV ID-19 vaccines pushed t hem i nto t he sp ot l ight of ma i nst rea m media—but the sudden acquisition of three separate biologics compa- nies, and more specif ically biologics CDMOs that can quick ly help sat- isfy incoming demand, may indicate that this shif t is happening much sooner than many would have antic- ip at e d . I n c onj u n c t ion w it h t h e moves made by Merck and Catalent, it becomes evident that these com- pa n ie s a re r ac i ng to e x pa nd i nto mRNA as soon as possible. SAMSUNG BIOLOGICS BETS BIG ON BIOSIMILARS On Jan. 27, 2022, Samsung Biologics announced that it would fully acquire Samsung Bioepis, buying out Biogen's share in the joint-venture company for US$2.3 billion. Formed by the t wo companies in 2012, Samsung Bioepis specia l iz es in producing biosimi- lars and currently has biosimilars for etanercept, inf liximab, adalimumab, trastuzumab, bevacizumab, and ran- ibizumab available in various global markets, along with four other biosim- ilars in development (6). The biosimilar market has seen noticeable shifts over the course of the past year, particularly in the United States. FDA approved the first inter- changeable biosimilar in July 2021 (7), and since then the industry has seen the f irst approvals of biosimilars for other major drugs like Humira (8) and Lucentis (9), the latter coming from Samsung Bioepis. Samsung Biologics interest in the field does not come as a surprise, but doubling down with a multi-billion dollar investment in the f ield will quell some concerns about the market being a f lash-in-the-pan. TEN23 HEALTH'S STRONG START While far from a major player in the industry, ten23 health has begun to turn heads for a couple reasons. First, because it's one of the newest CDMOs in the industr y—the Swiss start-up was launched in the beginning of last September by the 3i group, boasting former Lonza Head Head of Drug Product Ser v ices Hanns-Christian Mahler as its inaugural CEO (10). W hat 's especia l ly notable, how- ever, is that the young company has already dipped its toe into acquisitions. In late October 2021, less than two months after its inception, it acquired Swissf illion to enhance sterile drug produc t de velopment a nd bolster biologics manufacturing (11). This aggressiveness, in tandem with its ped- igreed CEO, leaves ten23 an interest- ing CDMO to watch going forward. FUJIFILM CONTINUES INVESTING IN BIOTHERAPEUTICS SUBSIDIARY Fujifilm Diosynth Biotechnologies is a subsidiary of Fujif ilm Corporation that focuses on providing CDMO ser- vices relating to biologics, vaccines, and advanced therapies. On Jan. 26, 2022, the company announced the acquisition of a dedicated cell therapy manufactur- ing facility from Atara Biotherapeutics for US$100 million (12). Located in Thousand Oaks, Calif., the 90,000 ft.² site can produce both clinical and commercial cell therapies, including allogeneic T-cell and chimeric antigen receptor (CAR)-T immunotherapies. The site also has capacity to expand, which could prove important in the not-so-distant future in light of the company's recent actions. Earlier that same month, Fujif ilm announced an expansion to one of its existing facilities in Research Triangle Park, NC, doubling its process char- acterization capacit y. And prior to that, Fujifilm had announced similar expansions to its UK manufacturing facility in late 2020 (13). For those reading the tea leaves, the message is loud and clear: the biologics business is booming, and they don't expect it to stop anytime soon. "Fujifilm Corporation has invested over US$5.5 billion to grow the Bio CDMO business unit in order to pro- vide our customers with long-term support across a full-range of modal- ities, and manufacturing scales," said Tak atoshi Ishik awa, senior execu- t ive v ice-president, genera l ma n- ager, Bio CDMO Division, Fujif ilm Cor porat ion, in a compa ny press release. " With the addition of the dedicated site in California, Fujifilm continues to build for the future to meet the growing need of advanced therapies globally." Partnerships for Outsourcing Industry Update It's become evident that these companies are racing to expand into mRNA as soon as possible.

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