Catalent, Samsung Biologics, Sai Life Sciences, Aphena Expand

The latest from CDMOs, CMOs, and suppliers featuring Catalent, Samsung Biologics, AGC Biologics, Aphena Pharma Solutions, Sai Life Sciences, and others.

Chemicals/Chemical API Manufacturing

Charkit, Elé Corporation in Distribution Pact
Charkit Chemical Company, part of LBB Specialties, a specialty chemical and ingredients distribution company, has signed a domestic territory-based representation agreement with Elé Corporation a Chicago, Illinois-based chemical distributor.

Source: Charkit Chemical Company

Biologics Manufacturing

Catalent To Acquire Cell-Therapy Mfg Company for $14 M
Catalent has agreed to acquire Skeletal Cell Therapy Support (SCTS), a cell-therapy manufacturing subsidiary of Bone Therapeutics, a Gosselies, Belgium-based cell-therapy company, for EUR 12 million ($14 million).

The acquisition includes all of SCTS’ assets located in Gosselies, Belgium. SCTS owns and operates a cGxP facility of approximately 41,000 square-feet, which includes related quality control and product development laboratories, a warehouse, cleanrooms, and equipment as well as land for further development. As part of the acquisition, all of the manufacturing employees located in Gosselies and employed by SCTS will remain with SCTS and become part of Catalent.

With the acquisition, Catalent will undertake the manufacturing of clinical material for Bone Therapeutics’ Allob, an allogeneic osteoblastic cell-therapy product, derived from ex vivo cultured bone marrow cells. The acquisition of SCTS is expected to close in November (November 2020).

The facility is next to Catalent’s existing cell-therapy site and will allow Catalent to develop a European center of excellence in cell therapies. Catalent is continuing work on a dedicated 60,000-square-foot commercial-scale production and fill–finish facility in Gosselies, which is scheduled to be completed by the end of 2021. Catalent acquired the facility as part of its $315-million acquisition of MaSTherCell, a CDMO specializing in development and manufacturing services for cell therapies, in a deal completed earlier this year (February 2020). As part of the MaSTherCell acquisition, Catalent also gained also a new 32,000-square-foot cell-therapy development facility in Houston, Texas, where validation is underway at the facility and is scheduled to be completed by the end of 2020.

Source: Catalent and Bone Therapeutics

Samsung Biologics Opens Contract Development Center
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has opened a new center in San Francisco, California for contract development services.

The new center parallels the development services offered by the company from its facilities in Incheon. The company says it plan to continue expansion into Boston, Europe, and China.

Source: Samsung Biologics

AGC Biologics Completes Acquisition of Cell and Gene Therapy CDMO
AGC Biologics, a biologics CDMO, has renamed MolMed S.p.A, a CDMO of cell and gene therapies that AGC Biologics recently acquired, to AGC Biologics S.p.A.

MolMed is based in Milan, Italy and provides CDMO services for cell and gene therapies and also is developing two proprietary chimeric antigen receptor (CAR) T-cell therapies. With the acquisition, AGC Biologics acquired two facilities for the development and commercial production of cell and gene therapies. AGC Biologics announced its acquisition of MolMed in July (July 2020) and completed the acquisition late last month (September 2020). The Milan site is now a center of excellence for cell and gene therapy CDMO services for AGC Biologics.

Source: AGC Biologics

DOD Awards Ology $6.3-M Contract for Tularemia Vaccine Candidate
Ology Bioservices, a biologics CDMO, has been awarded a $6.3-million contract from the US Department of Defense through the Joint Science and Technology Office of the Defense Threat Reduction Agency to manufacture a live attenuated tularemia vaccine. Tularemia is an infectious disease caused by the bacterium, Francisella tularensis.

Appili Therapeutics, a biopharmaceutical company based in Halifax, Nova Scotia, focused on infectious diseases, holds the global license of the vaccine candidate and serves as the vaccine’s candidate sponsor. In this program, Ology Bio will manufacture the vaccine candidate and perform a safety assessment using a rabbit model.

Source: Ology Bioservices

Formulation Development/Drug-Product Manufacturing

Aphena Completes $7-M Facility Expansion
Aphena Pharma Solutions, a CDMO and provider of contract packaging services, has completed a $7-million expansion and renovation of its facility in Easton, Maryland.

The newly renovated, 30,000-square-foot facility and three large, high-end blending suites are open for new pharmaceutical business. Aphena’s Maryland campus supports liquids, creams, gels, and suspensions.

The expansion includes three blending suites with two new Feldmeier 1,000-gallon mixing tanks and a sister 100-gallon tank, which offer center agitation mixing and dual alternate directional side sweeps for scale-up and registration batches. In addition, the tanks are jacketed for heat and chilling and are pressurized for powder mixing.

Source: Aphena Pharma Solutions


Sai Life Sciences To Open New Facility in India
Sai Life Sciences, a Hyderabad, India-headquartered CDMO of intermediates and active pharmaceutical ingredients and discovery chemistry services, has announced plans to expand its biology services at its R&D campus in Hyderabad, India with a 75,000-square-foot facility and an augmented team of 170 biologists. The new facility will house expanded in vitro and in vivo biology services, drug metabolism and pharmacokinetics (DMPK) services, and toxicology services, with the first set of labs scheduled to open in March 2021.

Last year (2019), the company opened its first international R&D facility with a biology lab in Boston, Massachusetts. The Boston Biology Lab is designed to offer start-up and biotech companies in the region biology services. The expanding team of biologists, DMPK, and toxicology scientists in India works with the Boston team.

Source: Sai Life Sciences

CPI Starts Construction on Medicines Mfg Center
The Center for Process Innovation (CPI), the process manufacturing arm of the UK government’s network of Catapult centers that are designed to encourage innovation in specific areas, has started construction of a new Medicines Manufacturing Innovation Center in Renfrewshire, Scotland.

The center will focus on innovative approaches in small-molecule drug and drug-product manufacturing. It will be available to companies to evaluate, test, and prototype processes using so-called “4.0 manufacturing technologies,” including continuous, digital, and autonomous manufacturing. The facility is due for completion in late 2021 and will be operational in early 2022. It is expected to eventually house over 80 staff in both technical and non-technical roles.

The center is a collaboration between CPI, the University of Strathclyde in Glasgow, Scotland, and founding industry partners, GlaxoSmithKline and AstraZeneca. Funding is provided by the Scottish Enterprise, a government economic development organization, and UK Research and Innovation, a body of the UK government providing funding for research and innovation.

Source: Center for Process Innovation

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