Manufacturing Roundup: Terumo BCT partners with BioBridge subsidiary to manufacture cell and gene therapies; WuXi STA opens plant for HPAPI production

2022-06-30

合作基因疗法细胞疗法疫苗

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game. According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions. Both parties have signed the new agreement to further combine technologies and expertise to cater to the demand across the cell and gene therapy industry for smart systems that are automated and closed. This collaboration will look to lean on the expertise of Terumo and GenCure to establish a reference manufacturing center for BioBridge Global. This includes both organizations developing core process and manufacturing operations, with its base at GenCure’s process development and cGMP manufacturing facility in San Antonio. The collaboration is scheduled to last three years and occur in two phases. The first phase will enable Terumo to select from its portfolio of gene therapy manufacturing devices and share the range of services offered at GenCure. This combination is aimed to help solve industry gaps in manufacturing capacity and operational expertise. The second phase will allow GenCure and other BioBridge Global subsidiaries to use Terumo’s data management and value-added services to transition between clinical and manufacturing sites by enabling chain-of-custody/identity and consistency of leukapheresis products. “Despite the rapid evolution of the cell and gene therapy sector, critical challenges such as management between the collection, manufacturing sites and logistics still remain unresolved. For over 20 years. Terumo has been working with BioBridge to provide safe, high-quality blood products. We are now combining our product portfolios, expertise and management to provide a vital link between cell collection sites and cell and gene therapy manufacturing sites while addressing capacity and ensuring GMP production,” said Delara Motlagh, general manager of cell therapy technologies at Terumo. WuXi STA has been on a roll over the past year, expanding its operations in Europe and the US, but it is turning to China for its next opening. According to the company, it has opened another high-potency API(HPAPI) plant at its Changzhou site located in Jiangsu, China. The new plant is designed to meet the growing demand for high-potency APIs. While the company did not disclose the financial details or employee headcount of the plant to Endpoints News , the plant is over 12,000 square-feet and is open and now in operation. The plant’s manufacturing services consist of reactors from 250 L to 3,000 L, prep-HPLC systems, a 10 m2 tray lyophilizer, as well as flow chemistry and milling technologies. WuXi STA’s most current plant adopts advanced isolation technologies with the capability to handle potent compounds with OEL as low as 10 ng/m3. Currently, WuXi STA has two other sites located in Shanghai and Changzhou to support the development and manufacture of HPAPIs as well. Last year, the CDMO acquired Bristol Myers Squibb’s site in Couvet, Switzerland — which specializes in commercial-scale production of various capsules and tablet dosage forms. The company also settled on New Castle County, DE, as the home for its newest CDMO site. The company plans to build on 190 acres and add up to 50 local jobs by 2026. After quick work, Avid Biosciences is looking to expand its horizons once again and dive headfirst into the competitive cell and gene therapy space. The company has opened a new 53,000-square-foot viral vector cGMP manufacturing site down the road from its Tustin, CA, headquarters in Costa Mesa, CA, after only eight months of construction. The site was scheduled to open in January 2023 but has sped along and will see Avid look to run in an ever-competitive market as the site will serve manufacturing in the cell and gene therapy market. At full build-out will include capacity for adherent and suspension cultures. The second phase is expected to become operational in the mid-calendar year 2023. The site will also look to bring the company’s potential revenue to around $350 million. “Expanding our offerings into viral vectors was a natural adjacency for Avid, as previously explained by our CEO, Nick Green. However, the work really came down to finding a design-build partner with the process, design, and construction expertise to help us deliver a best-in-class facility within a constrained schedule and budget,” said Mike Alston Jr., director of project engineering for Avid Bioservices. This comes on the heels of Avid investing $6 million , expanding its laboratories in Tustin around its capacity for its mammalian cell business. That expansion could support an additional $20 million in annual process development revenue, doubling the company’s current process development capacity. While focused on R&D capabilities and contracts in the past, the Dutch-based Batavia Bioscience will enter the full commercial manufacturing game. The company announced that it will extend its CDMO services portfolio to include commercial manufacturing services. To accommodate this shift, the company has finalized the design plans of its new 12,000-square-meter building to be realized at the Bioscience Park in Leiden, The Netherlands. It is expected that the manufacturing facility will be operational sometime in Q3 of 2024. No financial details on the plant were disclosed. The multi-product facility is designed to support the late-stage clinical manufacturing and commercial manufacturing of vaccines and viral vector-based gene therapy and immune-oncology products. Batavia’s manufacturing technology, called HIP-Vax, which utilizes fixed-bed bioreactors, will be the main platform. However, the company will also utilize products manufactured using traditional mammalian cell suspension technologies up to 1000L scale can readily be delivered. “This is a major step for Batavia as the company transitions from a CDMO that could assist its clients in R&D and clinic manufacturing only, to now, a ‘one-stop-shop’ where it will be able to support clients from concept product idea all the way to full market launch and commercial manufacturing,” said Menzo Havenga, Batavia CEO. The Bay Area is getting another lift in the manufacturing field. Commercial real estate company, Transwestern Ventures (TWV) and the city of Vacaville, CA, will develop a 390,000-square-foot biomanufacturing campus on 22.4 acres in Vaca Valley Business Park, located at the interchange of I-80 and I-505. According to Transwestern, the project will be built in two phases, with the first phase comprising 233,888 square-feet with delivery estimated in Summer 2024, with the second comprising 158,316 square-feet. Vacaville is situated along the main thoroughfare between Sacramento and the rest of the Bay Area. Companies such as Agenus, Kaiser Permanente, Genentech and Polaris also have a presence in Vaca Valley Business Park. The site newly acquired by TWV was sourced by Transwestern Real Estate Services and purchased in an off-market transaction. In an email to Endpoints News , Transwestern did not disclose the financial details but stated that the manufacturing at the campus will ultimately be determined by user demand but most likely related to the life sciences and/or food technology industries. The project is being designed with maximum flexibility to accommodate a variety of users. Transwestern is now actively searching for tenants for the facility, but though no one has signed on yet, it estimates the location will have around 500 employees at the fewest.