Supplier News: Resilience, Almac, WuXi STA & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Reslience, Almac Group, WuXi STA, Cellipont, and Grand River. Highlights below.
* Resilience, Mayo Clinic Partner for Cell-Therapy Labs, Mfg
* Cellipont Plans Commercial Cell-Therapy Mfg Facility
Formulation Development/Drug Product Manufacturing
* WuXi STA Breaks Ground on New US Mfg Campus
* Grand River Aseptic Manufacturing Updates Expansions
* Almac Investing $65 M To Expand Clinical Supply Ops
Resilience, Mayo Clinic Partner for Cell-Therapy Labs, Mfg
National Resilience Inc., a CDMO of biologics and advanced therapies, has formed a collaboration with the Mayo Clinic to build process and analytical development labs, quality control labs, and early-stage manufacturing support for cell therapies and other advanced modalities at the Mayo’s Center for Regenerative Medicine in Rochester, Minnesota. The labs will be for projects between Resilience and the Mayo Clinic and will also be available to other third parties.
The collaboration focuses on the following initiatives: (1) process and analytical development; (2) biomanufacturing for early-stage cell and gene therapeutics; (3) analytical testing and quality control required for manufacturing commercial-grade biopharmaceuticals; (4) a business incubator for healthcare entrepreneurs, start-ups, and industry experts; and (5) access to clinical trial capabilities and patients.
In June (June 2022), Resilience formed a joint venture with the University of Texas MD Anderson Cancer Center in Houston, Texas, for a 60,000-square-foot cell-therapy manufacturing facility in the Texas Medical Center, focused on process and analytical development as well as early-phase and clinical-stage good manufacturing practices.
Resilience currently has 11 facilities across North America, with more than 1 million square feet of manufacturing space
Source: National Resilience Inc.
Cellipont Plans Commercial Cell-Therapy Mfg Facility
Cellipont Bioservices, a Poway, California-based CDMO of cell therapies, has announced plans for a 76,000-square-foot commercial manufacturing facility for cell therapies and gene-modified cell therapies in The Woodlands, Texas.
The facility will include manufacturing, process development, assay development, and testing capabilities redundant with Cellipont’s 26,000-square-foot facility in San Diego, California. The new facility will be commissioned in phases, with the first phase scheduled to begin operation in the first half of 2023.
Source: Cellipoint Bioservices
Formulation Development/Drug Product Manufacturing
WuXi STA Breaks Ground on New US Mfg Campus
WuXi STA, a subsidiary of WuXi AppTec, has broken ground for its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware, its second facility in the US. The site will provide both drug-substance and drug-product manufacturing.
Phase I of the new campus will provide formulation development, clinical and commercial drug- product manufacturing for oral and injectable dosage forms, as well as packaging, labeling, storage, and distribution for clinical trial materials and commercial drug products.
The facility is expected to begin operations in 2025 and create approximately 500 full-time jobs by 2026.
Source: WuXi STA
Grand River Aseptic Manufacturing Updates Expansions
Grand River Aseptic Manufacturing (GRAM), a CDMO of parenteral drugs, has completed Phase II of an expansion of its facility in Grand River, Michigan, to includes the installation of two new sterile Bausch+Ströbel filling lines. With the expansion, the company now has a total of three separate fill lines and filling capacity of over 50 million units per year.
In addition to completing Phase II, GRAM has progressed Phase III of its facility expansion, which the company announced in April (April 2022). That expansion will add more filling and finishing capacity and is scheduled to be completed in 2024.
Almac Investing $65 M To Expand Clinical Supply Ops
Almac Group, a Craigavon, UK-based CDMO of active pharmaceutical ingredients and drug products, is investing $65 million for a 100,000-square-foot expansion of clinical supply operations at its North American headquarters in Souderton, Pennsylvania.
The investment increases clinical capacity at the facility by 60%, with additional cold and ultra-low storage and just-in-time processing capabilities.
Specifically, the investment will add the following capacity: (1) a 200% increase in 2-8°C storage; (2) a 140% increase in 2-8°C packaging; (3) a 100% increase in 20°C packaging; (4) a 30% increase in 15-25°C storage; (5) a 115% increase in ultra-low storage; and (6) a 100% increase in just-in-time manufacturing.
Almac will break ground for the expansion in early 2023, and the expansion is expected to be completed in in 2024. Upon completion, the expansion will bring the company’s North American headquarters footprint to a total of 340,000 square feet.
The North American Headquarters expansion follows the company’s announcement last month (July 2022) of overall planned investment in its Pennsylvania operations and facilities of $93.5 million over the next three years (as reported on August 11, 2022) and over $250 million for the company globally during the same period.
Source: Almac Group