Supplier News: Fujifilm, Novasep, CordenPharma & More
The latest from CDMOs, CMOs, and suppliers featuring Fujifilm Diosynth Biotechnologies, Novasep, CordenPharma, Wacker, Fareva, Apiject, Alcami, Avantor, Cytiva, Roquette, PCI Pharma Services, LSNE, Nanopharm, and Quay Pharma.
Chemicals/Chemical API Manufacturing
Novasep Invests in API Production Expansion
Novasep, a Lyon, France-based CDMO of active pharmaceutical ingredients (APIs) and antibody drug conjugates, is investing EUR 6 million ($6.7 million) to expand its API production capacity at its site in Chasse-sur-Rhône, France.
The investment also includes installation of a cGMP flow reactor for reactions involving flow chemistry for clinical supply and product launch.
Fujifilm Investing $300-M in Advanced Therapy, Vaccine Mfg
Fujifilm Diosynth Biotechnologies, a biologics CDMO and subsidiary of Fujifilm Corporation, has announced a $300-million expansion of its single-use manufacturing campus in College Station, Texas through the addition of a new production facility that will double the company’s advanced therapy and vaccine manufacturing capacity in the US.
The investment of approximately $300 million for facility construction is part of a previously announced $850-million global capital investment package initially outlined by Fujifilm in June 2021.
This new facility, expected to be operational by 2024, will add approximately 138,000 square feet to the existing campus and grow the site to 300,000 square feet. The new site will house multiple 500-L and 2,000-L bioreactors and associated purification equipment deploying single-use technology.
This investment is supported by a $1.5 million Texas Enterprise Fund Award to support the creation of approximately 150 positions, including manufacturing and operations by 2024.
Avantor Opens Single-Use Logistics Hub
Avantor, a supplier of ultra-high-purity materials for the life-sciences and advanced technology industries, has opened a new single-use logistics hub in Westminster, Massachusetts.
Located near the company’s Devens, Massachusetts manufacturing site, the new facility serves as a center for raw material storage, quality control, and distribution.
Avantor’s Westminster site is its sixth location in the US supporting single-use services. The company has single-use sites in California, Illinois, Massachusetts, New Jersey, and North Carolina.
In 2021, Avantor made investments in its single-use capabilities, including acquisitions of RIM Bio, a China-based manufacturer of single-use bioprocess bags and assemblies, and Masterflex, a manufacturer of peristaltic pumps and aseptic single-use fluid transfer technologies.
SGS Acquires CDMO Quay Pharma
SGS, a Geneva, Switzerland-based contract analytical testing company, has acquired Quay Pharma, a Deeside, UK-based CDMO of live biotherapeutics.
Quay will become part of SGS Health Science and will become the company’s global center of excellence for formulation, research and development. The acquisition is part of SGS’s strategy of increasing its services across the health-science supply chain.
Quay recently opened a dedicated sales office and development and manufacturing facility in the Greater Boston area.
Taiyo To Establish Gene-Therapy Mfg in Japan
Taiyo Pharma Tech, an Osaka, Japan-based bio/pharmaceutical company, is establishing a gene-therapy manufacturing facility in Japan as part of its CDMO services. The company will install a modular manufacturing unit (Cytiva’s FlexFactory) to make gene-therapy medicines based on adeno-associated viruses.
The companies anticipate that the time to install and open the factory will take approximately 14 months (as reported on December 9, 2021).
Formulation Development/Drug-Product Manufacturing
CordenPharma To Acquire Drug-Product Mfg Facilities from Vifor
CordenPharma has agreed to acquire three drug-product manufacturing facilities from Vifor Pharma, a specialty pharmaceutical company. Earlier this month (December 14, 2021), CSL agreed to acquire Vifor for $11.7-billion.
Under the signed share purchase agreement, CordenPharma acquires all shares in Vifor SA in Fribourg, Switzerland (including its Ettingen, Switzerland branch), and OM Pharma SA in Lisbon, Portugal, thus taking over Vifor Pharma’s finished drug-product manufacturing operations at the three sites.
CordenPharma says it will integrate the new facilities into its existing CDMO network and R&D plants across Europe and the US, and organize the operations of the Fribourg, Ettingen, and Lisbon sites under its small-molecule platform. The company plans to use the existing manufacturing workforce while continuing to produce and supply Vifor Pharma products. Vifor Pharma’s Swiss and Portuguese country commercial organizations, located in Fribourg and Lisbon, will remain with Vifor Pharma Group.
Vifor and CordenPharma anticipate closing the transaction in the first quarter of 2022, contingent on customary closing conditions. This divestment, including all financial implications, has been disclosed to CSL Limited.
CordenPharma, Wacker in Lipid-Nanoparticles Pact
CordenPharma and Wacker, a Munich, Germany-based chemical company and biologics CDMO, have signed a pact to develop lipid nanoparticles (LNPs).
The two companies plan to jointly develop processes for the manufacturing of LNPs. Within the partnership, both companies will first jointly build up research and development capacities for LNP formulations at their respective manufacturing sites, Wacker Biotech in Amsterdam and CordenPharma in Caponago, Italy.
The CordenPharma Caponago facility will supply the LNP formulation development, manufacturing and fill–finish. As a manufacturer of active ingredients, Wacker, at its Amsterdam biotech site, produces messenger ribonucleic acid (mRNA) actives. In addition, the company will also offer expertise in the production of plasmid DNA, an intermediate for mRNA.
PCI Completes Acquisition of LSNE
PCI Pharma Services, a CDMO and contract provider of packaging services, has completed its acquisition of LSNE Contract Manufacturing, a CDMO of fill–finish and lyophilization services.
The acquisition adds five facilities in the US (New Hampshire, Wisconsin) and Europe (Spain), with a sixth expecting approval early in 2022.
Fareva, ApiJect in $50-M Blow–Fill–Seal Pact
Fareva and ApiJect Systems, a Stamford, Connecticut-based provider of prefilled syringes, have entered into a 10-year licensing agreement under which Fareva will install three blow–fill–seal (BFS) production lines with capacity to fill–finish more than 500 million doses per year of vaccines and other large molecule injectable drugs using ApiJect’s prefilled injector technology.
Fareva intends to invest more than EUR 50 million ($56.2 million) for these three manufacturing lines, with support from the government of France.
The new lines will be in Fareva’s Annonay, France, site. Cleanrooms for these new lines will be operated in a Biosafety Level 2 environment to allow for the handling of most vaccines. The objective is to start the first validation batches in June 2022.
Roquette Plans US-Based Pharma Innovation Center
Roquette, a provider of excipients and food ingredients, plans to invest $25 million for a new Pharmaceutical Innovation Center in Pennsylvania.
The new facility will house an applied sciences facility, focusing on the research of excipients for oral-dosage forms, drug-delivery systems, nutraceutical APIs, and pharmaceutical ingredients. The new facility will employ approximately 30 people, including 20 highly skilled scientists.
The 23,000-ft2 US facility is due to open in the summer of 2022 and will house Roquette Pharmaceutical Solutions’ headquarters, serving as a hub for team members globally from its base in Spring House, Pennsylvania. It will complement the research in bio/pharmaceutical applications currently being undertaken in Singapore, as well as its central R&D function in France.
Nanopharm Plans Full-Service Expansion
Nanopharm, an Aptar Pharma company that provides contract research and development services for orally inhaled and nasal drug products, has announced plans for a new facility in Cwmbran, Wales, to expand its formulation and analytical capabilities.
Nanopharm has signed a long-term lease for a nearby building that is four times larger than its current premises in Newport, Wales. At 25,000 square feet and spanning three floors, the facility has been completely redesigned to house R&D and analytical laboratories, with construction expected to be completed in early 2022.
Alcami Acquires Masy BioServices
Alcami, a CDMO of drug products and provider of analytical testing services, has acquired Masy BioServices, a provider of biostorage and pharma support services.
Masy operates three biostorage facilities in Massachusetts, with a fourth facility coming on line in early 2022 (as reported on December 15, 2021). The company offers temperature storage for various materials, including vaccines, bio/pharmaceuticals, cell banks, tissues, compounds, and medical devices.
Masy’s other pharma support service operations are located in California, Pennsylvania, New Jersey, and North Carolina.