WuXi To Build US Facility; Sharp, Catalent Acquire Packaging FacilitiesBy
The latest news from CDMOs, CMOs, and suppliers featuring WuXi Advanced Therapies, WuXi Biologics, Catalent, Sharp, Colorcon, and Rentschler Biopharma.
WuXi Biologics To Build New Biomanufacturing Facility in US
WuXi Biologics, a contract biologics manufacturer, has signed a land deal with the Worcester Business Development Corporation for a clinical and commercial manufacturing facility in Worcester, Massachusetts at The Reactory, a 46-acre master planned biomanufacturing campus.
The approximately 107,000-square-foot, two-story facility will be operational in 2022 and create 150 new jobs.
Source: WuXi Biologics
WuXi Advanced Therapies Launches New CAR-T Cell Therapy Platform
WuXi Advanced Therapies, part of WuXi AppTec and a CDMO for advanced therapies, has expanded its service capabilities to offer a Closed Process CAR-T Cell Therapy Platform as a means to accelerate the timeline for cell and gene therapy development, manufacturing, and release.
The platform will provide advanced therapy companies with integrated capabilities for chimeric antigen receptor T cell (CAR-T) production, including: in-stock raw materials with established batch records; regulatory and technical expertise; process and analytical development; in-process and release testing; quality control and quality assurance oversight; and access to facilities with required capacity. The platform provides one of two modalities depending on dose requirements, using a list of pre-evaluated equipment, technologies and materials with developed closed processes for different unit operations.
Source: WuXi Advanced Therapies
Rentschler Biopharma Partners for Cell-Line Production
Rentschler Biopharma, a Laupheim, Germany-based biologics CDMO, and Horizon Discovery, a Cambridge, UK-based provider of gene editing and gene modulation for cell-line engineering, have signed a commercial licensing agreement under which the companies will partner their services for the production of highly complex proteins.
Under the agreement, Horizon’s CHOSource platform will be used in combination with Rentschler Biopharma’s in-house process for cell-line development for difficult-to-express proteins. Horizon’s gene-edited glutamine synthetase knockout Chinese hamster ovary (CHO) K1 cGMP-compliant cell line will complement Rentschler Biopharma’s existing service offering to provide a royalty-free means for the production of highly complex proteins. This will support researchers from early drug development through commercial manufacturing.
Source: Rentschler Biopharma
Formulation Development-Drug Product Manufacturing
Colorcon Launches On-Dose Drug Authentication Platform
Colorcon, a provider of film-coating systems and excipients, has launched SoteriaRx, a new platform of on-dose technologies and detection services for drug authentication.
The platform’s on-dose authentication provides a tool for tracking medicines from plant to patient and supply-chain authenticity and transparency by incorporating microtags in a pill, which then can be digitally read and recorded to provide authentication.
Catalent To Acquire Clinical Packaging Facility from Teva–Takeda
Catalent has agreed to acquire a clinical packaging facility in Minakuchi, located in the Shiga Prefecture of Japan, from Teva–Takeda Pharmaceuticals, a generics joint venture between Teva Pharmaceutical Industries and Takeda Pharmaceutical in Nagoya Aichi, Japan. With the acquisition, Catalent will establish a new clinical GMP manufacturing and distribution hub to support clinical studies. Financial details of the deal, which is expected to close on July 1, 2020, have not been disclosed.
The 60,000-square-foot facility will be the largest in the Catalent’s Asia Pacific clinical supply network. The new facility will provide clinical supply services, primary and secondary packaging capabilities, a range of temperature options for storage and distribution, as well as clinical returns and destruction services. It will operate in partnership with Catalent’s existing Japanese clinical supply facility at Kakegawa, which serves both local and global companies.
Sharp Acquires Packaging Facility from QPSI
Sharp, part of UDG Healthcare and a provider of contract packaging and clinical supply services, has acquired a pharmaceutical packaging facility from Quality Packaging Specialists International, LLC (QPSI).
The site, located in Macungie, Pennsylvania, six miles from Sharp’s Allentown, Pennsylvania site will offer primary and secondary pharmaceutical packaging, including bottling, blistering, vial labeling and medical device kitting as well as serialization services. Sharp says the Macungie site will commence an immediate integration to the Sharp facility network.
The 160,000-square-foot facility has full regulatory approval and comes with 12 primary production suites, space for multiple secondary packaging lines, 30,000 square feet of warehouse space and approximately 66,000 square feet of unused space. The acquisition allows Sharp to hire over 100 new personnel into the business.
The acquisition is the latest in a series of investment by Sharp. The company has invested over $60 million in its global facilities over recent years, including the following: (1) $21 million to expand capacity and capabilities at its Allentown and Conshohocken, Pennsylvania facilities; (2) $11 million for a new Clinical Services Center of Excellence in Wales; (3) $11 million to enhance injectable and cold-chain capabilities in the US, Belgium, and the Netherlands; and (4) $23 million in its refitted clinical facility in Bethlehem, Pennsylvania.
Source: UDG Healthcare/Sharp