Manufacturing roundup: Terumo Pharmaceutical Solutions expanding CDMO reach outside Japan; EUROAPI boosting production at Frankfurt site

2022-11-03

寡核苷酸细胞疗法疫苗

The CDMO arm of the Terumo Corporation is looking to branch out of Japan and offer its services in other nations. Terumo Pharmaceutical Solutions will expand its CDMO services to customers on the global market. The company has three sites in Japan and offers filling, assembly, design and packaging services will look to expand and work on a project that will “cover the early development stage to large-scale commercial production for global pharmaceutical customers.” So far, Terumo announced it will invest around 15 billion yen ($101.1 million) to expand its facility in Yamaguchi City and boost production by over 3 times its current production rate. “I am excited for what the future holds for Terumo as we are in a unique position being able to offer an integrated solution of primary container, fill & finish capability, and device assembly, in addition to our traditional offering of injection, primary container, and infusion therapy devices,” said Terumo Chairman Marco Chiadò Piat, in a statement. However, Terumo did not detail where its new customers are or what market it will be specifically targeting. It has been a few months since Sanofi’s API spinoff, EUROAPI, hit the Paris exchange , but the company is now looking to augment one of its production sites on the European mainland. EUROAPI announced that it is placing an €18 million ($17.6 million) investment into installing new equipment at its site in Frankfurt, Germany. The investment plans to “debottleneck” its current capacity and will allow for 500 kilograms of peptides and oligonucleotides to be produced by 2025. The investment plans are to be made in several stages. “Peptides and oligonucleotides constitute a growing market with limited available capacity; we expect this new equipment and debottlenecking to take us one step closer to being a market leader,” said Cécile Maupas, the chief CDMO officer for EUROAPI in a statement . The AAV manufacturer Avirmax CMC has put the finishing touches on a new facility in the San Francisco Bay Area city of Hayward, CA. According to Avirmax, it has received cGMP license approval from the California Department of Health’s Food & Drug branch. The 20,000-square-foot facility plans to make “rAAV drug products” for clinical investigations. The site is divided into three areas: developmental laboratories, testing laboratories and cGMP manufacturing suites. “Our team has extensive experience and knowledge in recombinant AAV technology development and rAAV manufacturing. With our new facility, Avirmax CMC Inc. can deliver high-yield and quality vectors efficiently, timely, and cost-effectively. Avirmax CMC Inc. is committed to continuously innovating and developing technologies in collaborative relationships with our customers and to solving challenges in rAAV vector process development and manufacturing,” said Avirmax CEO Chengjiang Liu in a statement . Swiss authorities discover bubbles in Pfizer vaccine Swissmedic has been informed that some of Pfizer’s bivalent vaccines have bubbles at present, which can lead to underdosing. The Swiss regulators have been informed by vaccination centers of the appearance of bubbles in the vaccine after being removed from the fridge. The organization is currently investigating and evaluating all possible causes alongside the “marketing authorization holder” and is also analyzing samples in its laboratory. The bubbles, according to Swissmedic, seem to be occurring when the syringes are prepared in advance, usually several hours. Some vials are already containing bubbles when removed from the storage fridge. As a precautionary measure, Swissmedic has informed all cantons and vaccination centers and will provide updates on the situation. Italian manufacturing company ReiThera has received the thumbs up from the Italian Medicines Agency to open a new production area at its facility in Rome to produce viral vectors for use in cell therapies and vaccines. The site will be able to create several types of AAVs and will be able to manufacture a maximum of 3,000L. Construction on the expansion started in 2020 with an investment of €15 million ($14.6 million) and expanding the facility to the tune of 1,500 square meters. “Thanks to the operational authorization of this expanded facility, the ReiThera team, which combines high-level scientific knowledge with extensive experience in the engineering and bioprocessing of viral vectors, will be able to support companies engaged in the development of products in the field of vaccines and advanced therapies, from the fine-tuning of small-scale production processes to production on a commercial scale,” said Stefano Colloa, the CTO and co-founder of ReiThera, in a statement .