Supplier News: Alcami, Charles River Labs, Ortec & More
The latest from CDMOs, CMOs, and suppliers featuring Alcami, Charles River Laboratories, Ortec, ReiThera, iBio, Wheeler Bio, and Terumo.
Chemicals/Chemical API Manufacturing
* Ortec Opens New European HQ, Mfg Center
Biologics Manufacturing
* Charles River To Expand Cell-Therapy Mfg Facility
* ReiThera Opens New Viral Vector Mfg Facility
* IBio To Divest CDMO Business
* CDMO Wheeler Bio Starts Construction of Biomanufacturing Facility
Formulation Development/Drug Product Manufacturing
* Alcami To Be Acquired by Two Investment Groups
Packaging
* Terumo To Increase Prefilled Syringes Capacity
Chemicals/Chemical API Manufacturing
Ortec Opens New European HQ, Mfg Center
Ortec, a Newcastle West, County Limerick, Ireland-based provider of chemistry services and chemical manufacturing, has opened its new European headquarters and a manufacturing and operations center in Newcastle West, County Limerick, Ireland.
The 26,000 square-foot facility is a dedicated cGMP manufacturing facility. In addition to product synthesis, other facility capabilities include USP/EP generated water, a full-service analytical laboratory, and an ISO 8/Class 100,000 cleanroom. The site will produce pharmaceuticals, combination products, and medical device materials.
Source: Ortec
Biologics Manufacturing
Charles River To Expand Cell-Therapy Mfg Facility
Charles River Laboratories, a Wilmington, Massachusetts-headquartered CRO/CDMO, has announced the expansion of its cell-therapy CDMO facility in Memphis, Tennessee. The expanded space is suitable for clinical and commercial cell-therapy manufacturing, with an additional nine processing suites, adding to an existing 16 cleanrooms.
The expansion comes after the company added to its capabilities for cell and gene therapies with the 2021 acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences.
Source: Charles River Laboratories
ReiThera Opens New Viral Vector Mfg Facility
The Italian Medicines Agency (AIFA) has granted ReiThera, a Rome, Italy-based CDMO of adeno-vectored vaccines, operational authorization to open its new EUR 15 million ($14.6 million) production area for the large-scale production of viral vectors for vaccines and gene therapies at its facility at Castel Romano Technopole, a research hub located in Rome, Italy. The facility can accommodate GMP production based on adenovirus, adeno-associated virus, and lentivirus starting from 50 liters up to a maximum of 3,000 liters. The facility has an area of 1,500 square meters and includes new bioreactors with scaled volume capacities of 200, 1,000 and 2,000 liters.
Source: ReiThera
IBio To Divest CDMO Business
iBio, a San Diego, California-based bio/pharmaceutical company focused on antibody immunotherapies, has announced plans to divest its CDMO business. Proceeds and cost-savings from the divestiture will be redirected to advancing the company’s lead immuno-oncology assets as well as the development of the RubrYc discovery engine, an artificial intelligence platform used to create the majority of iBio’s therapeutic candidates.
The divestment includes the sale of a 130,000-square-foot cGMP bioproduction facility. The company expects it may be able to complete a transaction in 2023, but does not have a dollar estimate for the sale.
In addition, iBio will commence a search for a new CEO and has begun a workforce reduction of approximately 60% of its current staffing levels (as reported on November 3, 2022), primarily focused on the workforce located at the facility in Bryan, Texas. After the conclusion of the workforce reduction, the majority of the company is expected to operate out of the company’s new drug discovery center in San Diego, California, which opened in September 2022.
Source: iBio
CDMO Wheeler Bio Starts Construction of Biomanufacturing Facility
Wheeler Bio, an Oklahoma City, Oklahoma-based biologics CDMO, and CRB, an Atlanta, Georgia-headquartered construction and consulting company, have started construction on Wheelier Bio’s 35,000 square-foot GMP facility for clinical drug-substance manufacturing of antibodies and recombinant proteins.
Source: CRB
Formulation Development/Drug Product Manufacturing
Alcami To Be Acquired by Two Investment Groups
Alcami, a Wilmington, North Carolina-based CDMO of drug products and analytical testing services, reports two investment groups, GHO Capital and The Vistria Group, have agreed to acquire the CDMO from Madison Dearborn Partners and Ampersand Capital Partners. GHO Capital and The Vistria Group will acquire a 50/50 controlling interest in Alcami. Ampersand and Alcami management will reinvest equity as part of the acquisition. Financial terms were not disclosed.
Source: The Vistria Group
Packaging
Terumo To Increase Prefilled Syringes Capacity
Terumo Pharmaceutical Solutions, the pharmaceutical division of Tokyo-based Terumo Corporation, medical device company, has announced it will expand its CDMO production facilities for pre-filled syringes at its wholly owned subsidiary, Terumo Yamaguchi, with an investment of JPY 15 billion ($102.2 million). The investment will increase production capacity by 3.5 times compared to when the plant started operation in 2016.
Source: Terumo Corporation
