AGC To Acquire Novartis Facility; Recipharm To Build Fill-Finish FacilityBy
The latest from CDMOs, CMOs, and suppliers featuring AGC Biologics, Recipharm, Thermo Fisher Scientific, LGM Pharma, Purisys, and Hermes Pharma.
Chemicals/Chemical API Manufacturing
Purisys Obtains Additional ISO Certifications
Purisys, an Athens, Georgia-based supplier of active pharmaceutical ingredients (APIs), contract CDMO services, and pharmaceutical reference materials, has obtained two additional global ISO certifications: ISO 17025 (Testing and Calibration Laboratories) and ISO 17034 (Reference Materials Producers).
ISO 17025 provides a second level of certification beyond the core ISO 9001-compliant quality management system standard by certifying that quality-oriented tests are performed correctly and that the organization produces quality products. ISO 17034 is a third level of certification focusing on certified reference material manufacturers.
AGC Biologics To Acquire Novartis Facility To Expand Cell, Gene Therapy Services
AGC Biologics, a contract biologics manufacturer, has signed a purchase agreement for a cell- and gene-therapy commercial manufacturing facility in Longmont, Colorado, currently owned by Novartis.
The Longmont facility adds 622,000 square feet of operations and office space within six buildings on the overall 229-acre campus. This facility is near AGC Biologics’ large-scale mammalian facility in Boulder. AGC says it aims to hire a percentage of the staff employed by Novartis at the facility.
AGC Biologics recently announced an expansion at its Cell and Gene Therapy Center of Excellence in Milan, Italy. AGC has invested in cell- and gene-therapy manufacturing services since the acquisition of MolMed in 2020.
Source: AGC Biologics
Thermo Fisher Expands Adeno-Associated Viral Mfg
Thermo Fisher Scientific has expanded its portfolio of adeno-associated viral (AAV) manufacturing with a new media panel, gene kit, and advanced purification resins.
The Gibco Viral Vector HEK Media Panel covers a variety of HEK293 cell types. Its formulations will assist AAV developers identify a formulation for target cell line.
The Applied Biosystems resDNASEQ Quantitative Plasmid DNA-Kanamycin Resistance Gene Kit offers measurement of residual plasmid DNA. It includes a multiplex qPCR assay with all reagents and sample prep options. The kit targets conserved regions of multiple kanamycin-resistance gene families by covering all common plasmids with kanamycin-resistant genes used in bioproduction for applications such as triple transfection of host cells to produce AAVs.
The Poros CaptureSelect AAV affinity purification resins are for downstream processing of viral vectors.
Source: Thermo Fisher Scientific
Formulation Development/Drug Product Manufacturing
Recipharm Signs Memorandum of Understanding for Fill-Finish Facility in Morocco
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has signed a memorandum of understanding (MOU) with the Moroccan government and a consortium of the country’s banks to operate a new fill-finish factory in Morocco.
The factory is planned to be operational by 2023 and will mirror Recipharm’s new fill-finish line at its facility in Monts, France on a larger scale.
As part of the MOU, approximately $500 million will be invested by the Moroccan government and consortium over the next five years (as reported on July 6, 2021) to establish both capacity and capability for the manufacturing of vaccines and biotherapeutics in Morocco. The investment is primarily to supply the African continent and gain vaccine sovereignty and access to future biotherapeutics.
Hermes Pharma Reports Spin-Out from Hermes Arzneimittel
Hermes Pharma, a Pullach, Germany-based CDMO specializing in the development and manufacture of oral dosage forms, has spun out from Hermes Arzneimittel and has formed a separate legal entity named Hermes Pharma GmbH.
As a result, Hermes Pharma GmbH and Hermes Arzneimittel will operate independently but remain part of the Johannes Burges Family Foundation. Hermes Pharma GmbH will move forward with the existing management team in place.
Source: Hermes Pharma
LGM Pharma Launches Analytical Testing, Stability Services
LGM Pharma, a Boca Raton, Florida–headquartered CDMO of APIs and drug products, has launched a new analytical service offering to provides analytical testing and stability services to pharmaceutical developers and manufacturers, including compounding pharmacies.
The company, which already conducts analytical services as part of its iCDMO activities, will now offer its analytical services expertise and facilities as a standalone contract service for pharmaceutical industry clients. LGM Pharma has a network of facilities in California, Colorado, and Texas, chromatography and spectroscopy equipment, and over 60 QA, QC, and analytical employees.
Source: LGM Pharma