Supplier News: Asahi Kasei, TriLink & More
The latest from CDMOs, CMOs, and suppliers featuring Axplora, Asahi Kasei Bioprocess, Axolabs, TriLink BioTechnologies, API Innovation Center, Apertus, 89bio, BiBo Biopharma Engineering, Kincell Bio and Imugene.
Chemicals/Chemical API Manufacturing
* Axplora Appoints New CEO
* Asahi Kasei Bioprocess, CDMO Axolabs Partner for New Oliogonucleotide Mfg Plant
* TriLink Bio Opens New mRNA Mfg Facility
* API Innovation Center Partners with Apertus for Producing Cancer Drug
* Bio/Pharma Company 89bio Contracts with China-Based CDMO for New API Mfg Plant
Biologics Manufacturing
* Kincell Bio To Acquire Imugene’s Cell-Therapy Mfg Facility
Chemicals/Chemical API Manufacturing
Axplora Appoints New CEO
Axplora, formerly Novasep-PharmaZell, a CDMO of small-molecule active pharmaceutical ingredients, intermediates, and antibody drug conjugated has named Martin Meeson, former CEO of Fujifilm Diosynth Biotechnologies, as its new CEO. He will succeed Sylke Hassel, who is stepping down from the CEO role with immediate effect (as announced on April 10, 2024)
Meeson has experience in managing and growing businesses globally at Fujifilm Diosynth Biotechnologies, where he worked for 15 years, eventually making his way to become the CEO.
Source: Axplora
Asahi Kasei Bioprocess, CDMO Axolabs Partner for New Oliogonucleotide Mfg Plant
Asahi Kasei Bioprocess (AKB), part of the Asahi Kasei Group, and Axolabs, a CDMO of drug substances, have announced a strategic partnership to build a 59,000-square-foot oligonucleotide cGMP manufacturing facility in Berlin, Germany.
Operations at the newly built facility are planned to commence in late 2024.
Source: Axolabs
TriLink Bio Opens New mRNA Mfg Facility
TriLink BioTechnologies, a San Diego, California-based CDMO of nucleic-acid based products and mRNA, has opened a new cGMP mRNA manufacturing facility.
The 32,000-square-foot facility was specifically designed for mRNA manufacturing to support late-phase drug developers from Phase II to commercialization. Located in the Sorrento Valley area of San Diego, the facility features individual Grade C cleanroom suites for mRNA manufacturing, increased mRNA capacity (1g to >100g per batch), in-house analytical services, and laboratory space for onsite quality control testing.
Source: TriLink BioTechnologies
API Innovation Center Partners with Apertus for Producing Cancer Drug
The API Innovation Center, a St. Louis, Missouri-based nonprofit pharmaceutical organization, and Apertus Pharmaceuticals, a St. Louis, Missouri-based CDMO, have entered a collaboration for the production of lomustine, a cancer medication in short supply, which will expand Apertus Pharmaceuticals’ manufacturing in Missouri.
Lomustine is a chemotherapy treatment used to treat glioblastoma, the most common and aggressive form of malignant brain cancer. The company will apply new continuous manufacturing technologies to produce lomustine.
Apertus will adopt the continuous flow advanced biomanufacturing process funded by the API Innovation Center and developed by the organization’s research members. As part of this collaboration, Apertus and the API Innovation Center will also invest in the establishment of an oncology production suite in Missouri to expand the state’s biomanufacturing base and Apertus’ ability to manufacture additional drugs.
Source: The API Innovation Center
Bio/Pharma Company 89bio Contracts with China-Based CDMO for New API Mfg Plant
89bio, a San Francisco, California-based bio/pharmaceutical company, has entered into a collaboration with BiBo Biopharma Engineering, a Shanghai-based CDMO of active pharmaceutical ingredients (APIs), under which BiBo will construct a production facility to supply 89bio with pegozafermin, a drug for treating nonalcoholic steatohepatitis (NASH).
Under the agreement, BiBo will build the facility at BiBo’s facility in Shanghai to manufacture the bulk active ingredient required to produce pegozafermin for commercial supply. The platform is expected to provide 89bio with the manufacturing capacity to meet its commercial needs based on current projections.
Under the agreement, 89bio will pay BiBo an aggregate of $135 million toward the construction of the facility, of which 45% of the payment will be payable in the third quarter of 2024. The remainder of the payment will become payable upon achievement of certain specified milestones, of which up to an additional approximately 45% of the payment could become payable within the next 12 months, depending on the timing of achievement of certain milestones.
Source: 89bio (collaboration agreement) and 89bio (pegozafermin information)
Biologics Manufacturing
Kincell Bio To Acquire Imugene’s Cell-Therapy Mfg Facility
Kincell Bio, a Gainesville, Florida-based CDMO of cell-therapies, and Imugene, a Sydney, Australia-based bio/pharmaceutical company, have formed a strategic manufacturing and process development partnership, which includes the sale of Imugene’s North Carolina cGMP manufacturing facility and the transfer of process and analytical development activities to Kincell in a deal worth up to $6 million.
The 32,800-square-foot facility is designed with the flexibility to expand in capacity and scope to support the manufacture of cell-based therapies. Kincell intends to evolve the site capabilities to manufacture autologous and allogeneic products.
Under the agreement, Kincell will acquire Imugene’s cell-therapy manufacturing facility in North Carolina, for a total consideration of up to $6 million in upfront and milestone-driven payments. Both parties have entered into a manufacturing supply agreement whereby Kincell will manufacture Imugene’s azer-cel to support ongoing clinical trials. Imugene will also transfer process and analytical development of azer-cel to Kincell in order to support process and method optimization for commercial readiness.
Source: Kincell Bio
