CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Rentschler Biopharma, Fujifilm, Cobra Biologics, Recipharm, and Kindred Biosciences.
Biologics Manufacturing
Rentschler Biopharma, BioNTech in COVID-19 Mfg Vaccine Pact
Rentschler Biopharma, a Laupheim, Germany-based biologics CDMO, has entered into an agreement to serve as CDMO partner for BioNTech, a Mainz, Germany-based immunotherapy company, which is partnered with Pfizer for the development of a COVID-19 vaccine.
As an initial project, Rentschler Biopharma will be responsible for key aspects of cGMP drug-substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech and that is currently in a global Phase III clinical trial. Under the agreement, Rentschler Biopharma will be responsible for downstream processing. Process and product-related impurities will be removed from the intermediate pool, which had been previously derived from mRNA synthesis. Rentschler Biopharma will produce purified drug substance at its facilities at its headquarters site in Laupheim, Germany.
In addition to large-scale production services for the COVID-19 vaccine, the agreement also provides for small-batch manufacturing of BioNTech’s other RNA programs for use in clinical trials.
Source: Rentschler Biopharma
Fujifilm, VLP Therapeutics in Mfg Pact for COVID-19 Vaccine
Fujifilm has entered into an agreement with VLP Therapeutics Japan, a wholly owned subsidiary of the Gaithersburg, Maryland-based vaccine research and development company VLP Therapeutics, for the development of a COVID-19 vaccine candidate by VLP Therapeutics.
VLP Therapeutics’ COVID-19 vaccine is a self-amplifying (replicon) RNA vaccine that uses a lipid nanoparticle formulation to deliver the vaccine. Fujifilm will use its manufacturing facilities and infrastructure to support process development and manufacturing of the lipid nanoparticle formulation for clinical trials.
The vaccine is funded by the Japan Agency for Medical Research and Development. VLP Therapeutics with conduct preclinical and clinical trials of the vaccine in Japan in collaboration with several groups in Japan: the National Center for Global Health and Medicine; the National Institutes of Biomedical Innovation, Health and Nutrition; Oita University; and Osaka City University.
Source: Fujifilm and VLP Therapeutics
Cobra Biologics, Scancell in Mfg Pact for COVID Vaccine
Cobra Biologics, a CDMO of biologics, has formed a collaboration with Scancell, an Oxford, UK-based developer of immunotherapies for cancer and infectious diseases, for Cobra to manufacture Scancell’s COVID-19 vaccine.
Under the agreement, Cobra will produce plasmid DNA needed to generate the DNA vaccine for a Phase I clinical trial in 2021. The project is funded by a grant from Innovate UK, part of UK Research and Innovation, the UK national funding agency for science and research, that was awarded to a consortium consisting of Scancell, the University of Nottingham, and Trent University, in August (August 2020). The companies say the initial stages of manufacture are scheduled to start imminently (as reported on October 2, 2020).
Source: Cobra Biologics and Scancell Holdings
Kindred Biosciences, Vaxart Expand Mfg Pact for COVID-19 Vaccine
Kindred Biosciences, a Burlingame, California-based biopharmaceutical company with a CDMO business, has expanded an agreement with Vaxart, a South San Francisco, California-headquartered developer of oral recombinant protein vaccines, for the manufacture of Vaxart’s oral vaccine for COVID-19 and other vaccine candidates.
The manufacturing services will be performed via Centaur Biopharmaceutical Services, a wholly owned subsidiary of Kindred Biosciences that provides CDMO services.
Under the expanded agreement, Kindred’s California plant will be responsible for scaling the COVID-19 clinical trial material into mid-size bioreactors and its Kansas plant will be responsible for manufacturing at 2,000-L scale in single-use bioreactors.
Source: Kindred Biosciences
General
Recipharm, Arcturus in Mfg Pact for COVID-19 Vaccine
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has entered into an agreement with Arcturus Therapeutics, a clinical-stage messenger RNA (mRNA) medicines and vaccines company, for the manufacture of ARCT-021, Arcturus’ COVID-19 vaccine candidate that is in an ongoing Phase I/II clinical trial.
The companies say they are working together to secure commercial manufacturing production for 2021 and the future.
Source: Recipharm and Arcturus Therapeutics
