Supplier News: Fujifilm, WuXi STA, Catalent & More
The latest from CDMOs, CMOs, and suppliers featuring Sterling Pharma Solutions, Aceto, Fujifilm Diosynth Biotechnologies, the Center for Breakthrough Medicines, CuriRx, WuXi STA, Catalent, Recro Pharma, Sharp, West Pharmaceutical Services, and Colorcon.
Chemicals/Chemical API Manufacturing
Sterling Begins Early-Phase Development Expansion
Sterling Pharma Solutions, a Dudley, UK-based CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, has begun a $2.1-million expansion project to increase chemical and analytical capabilities at its facility in Cary, North Carolina.
The project will include the construction of five new laboratories, two of which will be dedicated to research and development; a scale-up chemical synthesis laboratory; and quality control and analytical services laboratories. All work is due to be completed by the end of 2022, and will allow for the recruitment of up to 20 additional scientists at the facility.
This announcement follows several recent investments, including acquisition of its Germantown, Wisconsin site in from Alcami in 2020 and a dedicated antibody-drug conjugate facility in Deeside, UK in 2021.
Source: Sterling Pharma Solutions
Aceto Consolidates Six Mfg-Related Acquisitions
Aceto, a provider of specialty materials for life sciences and advanced technology end markets, has consolidated six manufacturing-related acquisitions, which the company made in the last 18 months.
The acquired companies include: (1) A&C, a manufacturer of specialty excipients, buffers, process solutions and raw materials; (2) A&C Bio Buffer, a manufacturer of custom buffer and chemical blend products used in the manufacturing of bio/pharmaceutical drug products and vaccines; (3) Cascade Chemistry, a manufacturer of APIs, regulatory starting materials, and advanced intermediates; (4) Finar, a manufacturer, supplier, and distributor of pharmaceutical excipients, lab chemicals, aquaculture inputs, and food-grade additives; (5) Islechem, a provider of contract research and development, analytical services and technical support services; and (6) Syntor Fine Chemicals, a fine chemical manufacturer offering process development and R&D services.
Fujifilm To Acquire Cell-Therapy Mfg Facility for $100 M
Fujifilm Corporation has agreed to acquire a cell-therapy manufacturing facility in Thousand Oaks, California, from Atara Biotherapeutics, a South San Francisco, California-based bio/pharmaceutical company, for $100 million.
The facility can produce both clinical and commercial cell therapies, including allogeneic T-cell and CAR T immunotherapies. Fujifilm Diosynth Biotechnologies, Fujifilms’ biologics CDMO and subsidiary, will operate the new site.
This acquisition is expected to be completed in April 2022. At closing, Fujifilm plans to offer positions to approximately 140 current manufacturing and quality staff at the site.
Center for Breakthrough Medicines, Penn in Gene-Therapy Pact
The Center for Breakthrough Medicines (CBM), a King of Prussia, Pennsylvania-based CDMO of cell and gene therapies, and the University of Pennsylvania’s Gene Therapy Program (GTP) have signed a collaboration agreement to combine UPenn’s expertise in the development of gene therapies with CBM’s manufacturing capacity and expertise.
Under the renewable five-year deal, CBM will have commercial rights to certain aspects of GTP’s gene-therapy manufacturing platform, advanced analytics, and any future process or analytical improvements achieved through its collaboration with GTP.
CuriRx Launches Bioprocessing, Analytical Center
CuriRx, a Wilmington, Massachusetts-based CDMO, has launched its Advanced Bioprocessing and Analytical Center to provide end-to-end support to developers of biotherapeutics.
Formulation Development/Drug-Product Manufacturing
WuXi STA Launches Parenteral Formulation Mfg Line
WuXi STA, a CDMO and subsidiary of WuXi AppTec, has launched a parenteral formulation manufacturing line at its site in WuXi, China.
The automatic sterile manufacturing line operates in a full isolation system with an annual capacity of 2 million units and features multiple filling modules and a built-in lyophilizer to fill vials, syringes, and cartridges of a full range of sizes, as well as to produce lyophilized powders.
In addition to the launch of its parenteral formulation manufacturing line, the company says a second sterile filing line with an annual capacity of 10 million units is scheduled to start operation in the third quarter of 2022 at the same site.
Source: WuXi STA
Catalent Expands High-Potency Micronization Services in US, UK
Catalent has completed a $10-million expansion in large-scale isolator units at its facilities in Malvern, Pennsylvania, and Dartford, UK, for the micronization of highly potent drug compounds.
The new isolator systems at both sites allow for clinical to commercial-scale jet-milling operations to be carried out under enhanced containment conditions, with occupational exposure limit values as low as 0.05 micrograms per cubic meter.
Catalent’s Malvern and Dartford sites both offer expertise in particle-size engineering technologies, including micronization, jet milling, mechanical milling, cryogenic milling and associated analytical services, and work alongside its network of commercial-scale manufacturing facilities.
Recro Gets $1.5-M US Gov’t Contract for Skin-Cancer Drug
Recro Pharma, a Gainesville, Georgia-based CDMO of oral solid drug products, has been awarded a new $1.5-million formulation development and manufacturing contract from the US government for clinical development of a topical dermal treatment for the prevention of skin cancer.
The company will formulate, manufacture and supply a topical dermal drug product containing a prespecified active pharmaceutical ingredient, as well as a matching placebo, for a planned cancer prevention clinical study, which is designed to evaluate the effects of chemoprevention with the investigational compound on the recurrence of basal cell carcinoma.
Source: Recro Pharma
Sharp Completes Construction of Gene-Therapy Pkg Suites
Sharp, a provider of contract packaging and clinical supply services, has completed the construction of new purpose-built production suites to facilitate the packaging, storage and distribution of gene therapies, at its facility in Heerenveen, the Netherlands.
The new secondary packaging area was designed to address the complexities of gene therapies specifically, labelling and packaging vials and injectables at low volumes and low temperatures, for distribution in cold and ultra-cold supply chains. The Heerenveen site complements similar capabilities available at the company’s facility in Bethlehem, Pennsylvania.
Source: Sharp Services
West, Corning in Injectable Drug-Delivery Pact
West Pharmaceutical Services and Corning, a material sciences company, have entered into an exclusive injectable drug-delivery supply and technology agreement.
The new collaboration includes a multimillion-dollar investment to expand Corning’s Valor Glass technology to enable injectable drug packaging and delivery systems for the pharmaceutical industry.
Source: West Pharmaceutical Services
Colorcon Invests in MES Company, Apprentice.io
Colorcon Ventures, the corporate venture fund of Colorcon, a developer of film-coating systems and excipients, has invested in Apprentice.io, a provider of intelligent manufacturing execution systems (MES) designed specifically for the life-sciences industry.
Apprentice offers an end-to-end platform with a suite of software applications designed to streamline batch-based manufacturing and remote collaboration. Services include intelligent batch execution, augmented procedures and workflows, predictive resource management, and training. The company says the platform grows more intuitive over time, using artificial intelligence, machine learning, and augmented reality.