CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring AMRI, Catalent, Lonza, and BD.
Chemicals/Chemical API Manufacturing
AMRI To Supply an API for COVID-19 Drug Candidate
AMRI, a CDMO, is partnering with ViralClear Pharmaceuticals, a subsidiary of BioSig Technologies, to manufacture the active pharmaceutical ingredient (API), merimepodib, a broad-spectrum antiviral agent, which is being evaluated as a potential treatment against COVID-19.
AMRI is ViralClear’s second US-based API supplier for merimepodib.
Last month (June 2020), ViralClear partnered with Catalent under which Catalent will be developing two oral dosage forms of merimepodib, a solution and a solid oral dosage form.
Catalent, Humanigen Expand Pact for COVID-19 Drug Candidate
Catalent and Humanigen, a clinical-stage biopharmaceutical company, have expanded their partnership, under which Catalent will provide development, manufacturing, and commercialization services for Humanigen’ lenzilumab, which is being evaluated as a potential treatment for COVID-19.
The Mayo Clinic recently announced data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia. A Phase III study is currently underway evaluating hospitalized COVID-19 patients.
To date (as reported on July 16, 2020), Catalent Biologics has provided early-stage development and clinical drug-substance manufacturing for lenzilumab at its facility in Madison, Wisconsin to support Humanigen’s ongoing clinical trials across various disease categories. Under the expanded partnership, Catalent is also providing clinical supply support for Humanigen’s Phase III potential registration study in COVID-19 from its Philadelphia facility.
Lonza, Junshi Biosciences Advance Antibody for COVID-19
Junshi Biosciences, a Shanghai-based biopharmaceutical company, has advanced a potential neutralizing antibody treatment, JS016, for COVID-19 into clinical trials in China; the antibody is produced using Lonza’s expression technology platform, GS Xceed expression system.
The first healthy volunteer was dosed in a Phase I clinical study of JS016 at Huashan Hospital, affiliated with Fudan University in Shanghai, China, last month (June 2020).
Junshi is collaborating with Eli Lilly and Company to co-develop JS016 globally, with Junshi leading clinical development in Greater China and Lilly leading clinical development in the rest of the world
BD Gets $42 M from US Gov’t To Expand Injection-Device Mfg Facility
Becton, Dickinson and Company (BD), a Franklin Lakes, New Jersey-based medical technology company, has formed a partnership under which the US government will provide $42 million to fund new manufacturing lines for injection devices for priority access for hundreds of millions of syringes and needles.
BD is partnering with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response under which BARDA will provide an estimated $42 million into a $70-million capital project to further expand BD’s operations and manufacturing capacity in Nebraska. The new capacity is expected to be on line within 12 months (as reported on July 8, 2020) and once completed, BARDA will have priority access to injection devices from these new manufacturing lines to support mass vaccination efforts for COVID-19 and future pandemics.
BD has also finalized an initial pandemic order for 50 million needles and syringes to be delivered by the end of December 2020 to support the US vaccination effort for COVID-19. This order will be fulfilled through BD’s current manufacturing capacity, and the company says it is working with the US government to finalize additional near-term quantities of injection devices for Operation Warp Speed, a US government program that aims to begin delivering millions of doses of a vaccine for COVID-19 in 2021.
In addition, BD has also been working with the White House Coronavirus Task Force, the HHS, and other federal agencies to expand access to diagnostic testing and support treatment of COVID-19 patients. Through June (June 2020), the company has supplied healthcare providers with approximately 48 million swabs for flu and COVID-19 testing, more than 2.85 million COVID-19 rapid molecular diagnostic tests, and millions of products used in the treatment of COVID-19, including infusion pumps, infusion sets, and catheters.
Source: Becton, Dickinson and Company