AGC Biologics is partnering with German pharma group, 4Teen4, to develop and manufacture its flagship product, the monoclonal antibody (mAb) called Procizumab.
Preclinical studies of Procizumab in models of cardiovascular failure showed instant efficacy, demonstrating this treatment’s tremendous potential, said the Berlin based 4Teen4. The mAb works by inhibiting the activity of its target, Dipeptidyl Peptidase 3 (DPP3), to stabilize cardiovascular function and potentially increase survival chances in incidences of cardiogenic and septic shock.
Under the terms of the agreement, the companies will collaborate to transfer and optimize the manufacturing process for the mAb.
The Seattle headquartered CDMO will produce the clinical trial materials at its site in Chiba in Japan. All late phase activities to support early and late clinical phases and launch readiness of 4Teen4’s monoclonal antibody, will then take place at AGC Bio’s Copenhagen, Denmark site, with AGC Bio stressing the high level of expertise the scientists at both the Japanese and Danish sites have in terms of the development and delivery of mammalian and microbial programs.
A company spokesperson told us the Chiba facility is the only one in Japan with microbial and mammalian capabilities within an integrated global network.
"General manager of that site, Jun Takami, has 15 years of experience in the pharmaceutical industry, with roles in process development, GMP manufacturing, process engineering and PLI activities with the Roche group at Chugai Pharmaceuticals. His leadership has been critical to the growth and development of this site, and its ability to take on more clients like 4Teen4."
The Copenhagen site, he added, is one of the CDMO's premier centers for mammalian and microbial biologics activities. "This site has capacity and technological flexibility, including extensive adoption of single-use systems."
The CDMO, which is also focused on the development and manufacture of plasmid DNA, viral vector and genetically engineered cells, recently announced expansion plans for the Copenhagen facility, aimed at doubling production capacity at the site to meet increased market demand.
Gene therapy trial material
The Netherlands based, Amarna Therapeutics, a privately-held biotech developing gene therapies in a range of rare and prevalent diseases, is currently completing IND enabling studies and has initiated manufacturing with the goal of starting a Phase 1/2a trial in around two years on its lead product, AMA005, which is designed to restore the blood clotting process in hemophilia B patients.
The developer has engaged Halix, a Dutch CDMO, to produce the material for the AMA005 study.
Technology transfer of Amarna’s production process to Halix's GMP manufacturing facility in the Leiden Bio Science Park in the Netherlands, is currently ongoing, said the partners.
Focused on the GMP development and commercialization of viral vector and recombinant protein products, among others, Halix provides both the manufacturing of drug substance through mammalian cell culture, and aseptic fill and finish including lyophilization services.
Amarna also reported this week that it had secured a further €4m (US$4.5) in funds from existing investors along with €1m of additional innovation credit from the Netherlands Enterprise Agency, RVO.
Aseptic drug product manufacturing
Another Dutch CDMO, BioConnection, specialized in GMP-certified manufacturing of sterile drug products in vials and syringes, has announced that Nykode Therapeutics AS, formerly Vaccibody, has selected it for the aseptic drug product manufacturing requirements for one of its vaccine candidates.
Nykode is developing vaccines and novel immunotherapies for the treatment of cancer and infectious diseases with a high unmet medical need.
Mette Husbyn, CTO of Nykode, said the company chose to partner with BioConnection as the CDMO’s manufacturing capabilities matched the Norwegian company’s exact early phase clinical trial needs. “Moreover, BioConnection has an excellent broad manufacturing and regulatory track record, including EMA and FDA certification.”
BioConnection CEO, Alexander Willemse, added: “Phase I trials usually require small batches of drug products that have to be delivered in a precise manner. Capitalizing on our years of experience, we offer automated filling in large volumes up to 40 million vials per year, and importantly also manual fill and finish.”
The Oss based CDMO said it was recently granted GMP certification for production of sterile drug products on its new large-scale filling line. That new production line, which has been validated as per the EMA and US-FDA quality guidelines, has an annual production capacity of up to 40 million vials for liquid products and up to four million vials for freeze-dried products, it added.