Supplier News: Cambrex, Hovione, Lonza & More
The latest from CDMOs, CMOs, and suppliers featuring Cambrex, Catalent, Hovione, MilliporeSigma, Lonza, NextPharma, Almac, Stevanato, Gerresheimer, and Aptar.
Chemicals/Chemical API Manufacturing
* Cambrex Completes Phase I of Small-Molecule API Expansion
* Almac Receives Grant for Enzyme Research in Flow Chemistry
Biologics Manufacturing
* MilliporeSigma Investing $130 M To Expand Single-Use Assemblies Mfg
* Lonza Partners for Enzymatic Method for mRNA Production
Formulation Development/Drug Product Manufacturing
* NextPharma To Acquire Mfg Site From Takeda
* Hovione Adds Continuous Tableting Facility
Packaging
* Catalent To Invest $2.2 M To Expand Clinical Supply Facility
* Stevanato, Gerresheimer Partner for Ready-to-Use Vials
* Aptar Pharma Acquires Metaphase Design Group
Chemicals/Chemical API Manufacturing
Cambrex Completes Phase I of Small-Molecule API Expansion
Cambrex has completed the first phase of a $30-million investment in its small-molecule active pharmaceutical ingredient (API) manufacturing facility in High Point, North Carolina. The newly constructed space adds analytical and chemical development laboratories totaling 30,000 square feet and provides future workspace for 85 analytical and chemical development scientists. These laboratories will support the development of APIs to be manufactured in the facility’s current clinical manufacturing area as well as the future expanded clinical manufacturing and commercial manufacturing suites.
Phase 2 of the project is ongoing and will approximately double the facility’s manufacturing capacity with the addition of clinical and commercial manufacturing suites with reactors up to 2,000 liters. The expansion follows Cambrex’s 2021 investment in the Cambrex High Point continuous flow R&D center of excellence, including expanded capabilities for continuous flow process development, manufacturing, and scale-up.
Source: Cambrex
Almac Receives Grant for Enzyme Research in Flow Chemistry
Almac Sciences, a member of the Almac Group, a CDMO of active pharmaceutical ingredients and drug products, and University College Dublin (UCD), have been awarded a grant of €420,000 ($480,000) from the Science Foundation Ireland for research of emerging enzymes such as ene-reductase (ERED) and carboxylic acid reductase (CAR) enzymes in continuous flow reactors to develop new routes to chemical products. Almac Sciences and UCD will work together to establish the use of enzymatic multi-step reactions in continuous flow reactors for fine-chemicals production.
The project team, co-funded by Almac Sciences, will include one postdoctoral researcher and two PhD studentships over the next four years (as reported on September 6, 2022), based primarily in UCD. Both PhD students have undertaken industry placements within Almac as part of their undergraduate studies.
Almac recently completed a £500,000 ($575,000) investment in flow chemistry. The new funding builds on methodologies applicable for industrial scale.
Source: Almac
Biologics Manufacturing
MilliporeSigma Investing $130 M To Expand Single-Use Assemblies Mfg
MilliporeSigma, the life sciences business of Merck KGaA, is investing EUR 130 million ($130 million) to increase manufacturing of single-use assemblies at its site in Molsheim, France. The investment is the largest ever in the 50-year history of the site and will create more than 800 jobs by the end of 2028.
The expansion will increase capacity for the manufacturing of single-use assemblies belonging to the Mobius portfolio. The 37,000-square-feet ISO7 cleanrooms, administrative building, and new logistics warehouse are planned to be operational by the end of 2024, and will gradually ramp up to full production through 2028. In 2021, MilliporeSigma added a EUR 25 million ($25 million) single-use assembly production unit. Molsheim is the first site in Europe where the company manufactures the product. Further production sites are located in Danvers, Massachusetts, and Wuxi, China.
Source: MilliporeSigma
Lonza Partners for Enzymatic Method for mRNA Production
Lonza has formed a collaboration with Touchlight, a Hampton, UK-based biotechnology company specializing in enzymatic DNA production, to add a differentiated source of DNA by providing access gain to Touchlight’s doggybone DNA (dbDNA) technology.
DNA serves as the starting template for the production of mRNA. Through an enzymatic in-vitro transcription process, this DNA sequence is then transcribed into a single-stranded RNA molecule, which is then processed into mRNA. dbDNA offers an alternative to the use of E. coli fermentation for manufacturing plasmid DNA, a commonly used raw material for mRNA. dbDNA is a linear, double stranded and covalently closed DNA construct. dbDNA can encode long, complex, or unstable DNA sequences, eliminates bacterial sequences, and has a strong expression profile, according to information from Touchlight.
Source: Lonza
Formulation Development/Drug Product Manufacturing
NextPharma To Acquire Mfg Site From Takeda
NextPharma, a London-based CDMO of oral and topical finished dosage forms, has agreed to acquire Takeda’s finished-product manufacturing site in Asker, Norway. With the closing of the transaction, which is expected in March 2023, approximately 170 manufacturing employees will transfer to NextPharma.
The Asker site produces a portfolio of strengths and flavors of calcium/vitamin D3 chewable tablets. Following the acquisition, the Asker Site will no longer produce finished products for Takeda. Takeda had acquired the site in 2011.
Source: NextPharma
Hovione Adds Continuous Tableting Facility
Hovione has brought on line a continuous tableting facility at it site in Loures, Portugal. In addition, the company has established a multi-disciplinary global team in continuous tableting and has upgraded its labs with the tools needed to support the drug-product lifecycle
Source: Hovione
Packaging
Catalent To Invest $2.2 M To Expand Clinical Supply Facility
Catalent has announced a $2.2-million expansion to its clinical supply facility in Singapore to increase the site’s footprint by nearly 20% to 31,000 square feet and to install 35 new freezers for ultra-low temperature (ULT) storage.
The expansion will also add specialized secondary packaging capabilities for ULT products to support larger packaging campaigns and to increase capabilities to handle biopharmaceuticals and advanced modalities, including mRNA-based vaccines, and cell and gene therapies.
Source: Catalent
Stevanato, Gerresheimer Partner for Ready-to-Use Vials
Stevanato Group, a provider of drug containment, drug delivery and diagnostic products and services, and Gerresheimer, a provider of pharmaceutical packaging and drug-delivery systems, have jointly developed a ready-to-use (RTU) platform with an initial focus on vials, based on Stevanato’s proprietary EZ-fill technology for pre-sterilized containers.
The RTU vials from Stevanato and Gerresheimer will share the same secondary packaging, production process, and sterilization method to ensure consistent available capacity and double sourcing availability. A key technology benefit of the new RTU platform is a reduction in particles.
Source: Stevanato and Gerresheimer
Aptar Pharma Acquires Metaphase Design Group
Aptar Pharma, a provider of drug-delivery and material science products and services, thas acquired Metaphase Design Group, a product-design company applying the science of human factors and engineering and ergonomics. Metaphase will be integrated into Noble, an Aptar Pharma company and provider of drug-delivery training device programs, medical device training products and services, and patient onboarding approaches to support Noble’s Human Factors Plus (HF+) program. Launched in 2021, Noble’s HF+ program provides services, such as device selection, product design solutions, human factors testing, risk analysis, packaging and labeling, and regulatory submission support
Source: Aptar Pharma
