Novasep, PharmaZell in Merger Talks; Lonza, Pii, Thermo Fisher ExpandBy
The latest from CDMOs, CMOs, and suppliers featuring Novasep, PharmaZell, Lonza, Thermo Fisher Scientific, Pii, Codexis, Samsung Biologics, Sartorius, and Arranta Bio.
Chemicals/Chemical API Manufacturing
Novasep, PharmaZell in Merger Negotiations
Novasep, a Lyon, France-based CDMO of active pharmaceutical ingredients (APIs) and antibody drug conjugates, and PharmaZell, a Raubling, Germany-based CDMO of small-molecule APIs, are in negotiations to combine the two companies.
The proposed transaction would be backed by PharmaZell’s current majority shareholder Bridgepoint Group, a private investment firm. The proposed acquisition remains subject to the fulfilment of customary conditions precedent for this type of transaction, including the information and consultation of works councils and other regulatory approvals.
A combined company would have revenues of EUR 500 million ($586 million) with approximately 2,000 employees across seven production and R&D sites in Europe (Germany, France, and Italy), two sites in India, and one in the US.
Merck & Co., Codexis Extend Biocatalyst Pact
Merck & Co. and Codexis, a Redwood City, California-based biocatalyst engineering company, have extended their license and supply agreement for a biocatalyst used in the manufacturing process for sitagliptin, the active pharmaceutical ingredient in Merck’s anti-diabetes drugs, Januvia and Janumet.
Under a research and development agreement, Codexis and Merck used Codexis’ CodeEvolver enzyme engineering platform technology to design an enzyme to serve as a biocatalyst in the sitagliptin manufacturing process.
In 2012 Codexis and Merck entered into a supply agreement for the enzyme and in 2015 signed a multi-year extension, which was to expire in February 2022. This extension and amendment is for the license and supply of the proprietary enzyme through December 31, 2026. The extension can be renewed for an additional five years upon mutual agreement by both companies.
Arranta Bio To Establish Contract Mfg Capacity for mRNA Vaccines
Arranta Bio, a CDMO of live therapeutic and other biologics products, has announced plans to establish contract manufacturing capacity for messenger RNA (mRNA) vaccines at its site in Watertown, Massachusetts. The company will provide an end-to-end platform for cGMP manufacturing of raw materials, in-vitro transcription, mRNA purification, lipid nanoparticle formulation, and sterile fill–finish.
In 2020, Arranta completed the built-out and commissioning of an 80,000-ft² commercial-ready facility in Watertown, with Grade C (ISO 7) cleanrooms, which are suitable for the production of mRNA, lipid nanoparticle formulation, and sterile fill–finish into vials within isolator technology. Arranta will have drug-substance process development and formulation-development capacity in place by the end of 2021 in existing laboratories and GMP clinical manufacturing by early 2022 from existing cleanrooms, which are already qualified. Integrated isolator technology will be installed and operational in the second half of 2022 to complete the end-to-end platform.
Source: Arranta Bio
Sartorius Opens New Application, Service Hub in China
Sartorius, a provider of products and services for the life sciences, has opened an expanded application and service hub in in Shanghai, China.
The hub covers over 3,000 square meters and accommodates the Sartorius Application Center 3.0, the Confidence Validation Services Laboratory 2.0, and APAC Service Hub. The combined facility supports the company’s products and services used research, process development, and production.
Sartorius is proceeding with other investments. Its newly opened Customer Interaction Center in Beijing for testing, validating, and adjusting equipment functionalities recently completed its first large-scale customer project. The Sartorius Laboratory and Service Center in Yantai, China, is under construction and is slated to become operational in the first half of 2022.
Clean Cells Investing $15 M in New QC, Cell-Bank Production Facility
Clean Cells, part Clean Biologics, a provider of bio/pharmaceutical product quality control services and manufacturer of starting materials, is investing EUR 13 million ($15 million) for a new production facility in Montaigu-Vendée, France.
The new 5,300-m2 facility will provide quality control and cell-bank production for the development of bio/pharmaceutical products. The construction of the new facility started in July 2021 and should be completed by September 2022.
Source: Clean Cells
Samsung Biologics Launches New Drug-Development Platform
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has launched S-Cellerate, a drug-development service platform for the development and commercialization of monoclonal antibodies.
Source: Samsung Biologics
Formulation Development/Drug-Product Manufacturing
Thermo Fisher To Invest $154 M To Expand Drug-Product Mfg
Thermo Fisher Scientific has announced a $154-million investment to expand its pharmaceutical drug-product manufacturing operations in Greenville, North Carolina.
The Greenville facility is a multi-purpose pharmaceutical manufacturing and packaging campus spanning more than one million square feet. This expansion will increase the manufacturing capacity for sterile liquid and lyophilized filling, pre-filled syringes, and solid dose continuous manufacturing.
Source: North Carolina Governor’s Office
Lonza To Expand Parenteral Drug-Product Development, Mfg
Lonza has announced an investment to expand parenteral drug-product manufacturing at its site in Stein, Switzerland and to expand its drug-products services facility in Basel, Switzerland.
This investment will fund an additional aseptic flexible filling line for clinical supply of drug products. The new line will support liquid and lyophilized vial filling and processing, cartridges, and pre-filled syringes. The installation is expected to be completed in 2023 and will create more than 70 new positions at the Stein site.
The company is also expanding its drug product services facilities in Basel for parenteral dosage forms to further support development for early- and late-clinical stages and increase the process development and characterization capabilities. The new facilities are expected to be operational in 2024.
Pii Expanding Sterile Fill-Finish Capacity
Pharmaceutics International, Inc. (Pii), a Hunt Valley, Maryland-based CDMO, is investing to increase capacity in its Bosch aseptic filling line for large-volume sterile fill-finish production.