CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects

The latest from CDMOs, CMOs, and suppliers in COVID-19 projects featuring MilliporeSigma, CordenPharma, Oxford Biomedica, and Kindred Biosciences.

Biologics Manufacturing

AstraZeneca, Oxford Biomedica in Mfg Pact for COVID-19 Vaccine
AstraZeneca and Oxford Biomedica, an Oxford, UK-based company specializing in research, development, and manufacturing of gene and cell therapies, have signed a one-year clinical and commercial supply agreement for the GMP manufacture of AstraZeneca’s adenovirus vector- based COVID-19 vaccine candidate, AZD1222, which recently entered clinical trials at multiple sites in the UK. Oxford Biomedica is working with AstraZeneca and other manufacturing organizations to provide large-scale manufacturing capacity for this vaccine candidate.

Under the agreement, AstraZeneca will have access to Oxford Biomedica’s 7,800-square-meter commercial manufacturing center, Oxbox, located in Oxford, UK. Earlier this year (April 2020), Oxford Biomedica announced that it had joined a consortium that included the Jenner Institute at Oxford University in the UK for the potential for large-scale manufacture of the COVID-19 vaccine candidate. On April 30, 2020 AstraZeneca and Oxford University subsequently announced an agreement to enable global development, manufacturing and distribution of the vaccine. Earlier this month (May 2020), AstraZeneca was awarded more than $1 billion from the Biomedical Advanced Research and Development Authority, part of the office of Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, for the development, production and delivery of Oxford University’s/AstraZeneca’s COVID-19 vaccine candidate.

The initial agreement requires Oxford Biomedica to provide AstraZeneca with multiple batches of vaccine, the majority of which are expected to be produced throughout 2020. The production will be from one of Oxford Biomedica’s recently approved GMP suites in Oxbox. The companies say the commercial supply agreement may be extended further depending on the progression of the program.

Source: Oxford Biomedica

MilliporeSigma, Baylor Extend Pact for COVID-19 Vaccine Mfg
MilliporeSigma and Baylor College of Medicine in Houston, Texas have extended their ongoing collaboration to advance a manufacturing platform for COVID-19 vaccines to accelerate the transition to enable Phase I clinical trials.

MilliporeSigma, along with researchers at Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine Development, is optimizing the production process to advance two COVID-19 vaccine candidates, including CoV RBD219-N1, a vaccine candidate expected to enter clinical trials later this year (2020). The CoV RBD219-N1 vaccine candidate was originally developed to target severe acute respiratory syndrome (SARS) in 2011–2016. MilliporeSigma will help to accelerate the suitability for large-scale manufacturing. The collaboration will focus on improvements to production efficiency, yield, robustness, scalability, and costs.

Additionally, the teams will develop a new manufacturing platform for a second COVID-19 vaccine candidate to shorten the time to enter into Phase I clinical trials. The goal for the partnership is to develop a manufacturing process and steps that would lead to a scale-up approach suitable for pilot and later industrial production.

Researchers from the Texas Children’s Center for Vaccine Development first formed a partnership with MilliporeSigma’s process development scientists and biomanufacturing engineers in 2018 to advance vaccine development and production and enhance the response to outbreaks.

The Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine Development received funding from the National Institute of Allergy and Infectious Diseases for their earlier work in developing the CoV RBD219-N1 vaccine candidate and recently to initiate development of the second COVID-19 vaccine candidate. In addition, Baylor and Texas Children’s Hospital, through their alliance with PATH, a global non-profit organization for improving public health, expect to advance the COVID-19 candidates to support access to low- and middle-income countries.

Source: MilliporeSigma

Kindred Biosciences, Vaxart in Pact for COVID-19 Vaccine Manufacturing
Kindred Biosciences, a Burlingame, California-based biopharmaceutical company with a CDMO business, has formed an agreement with Vaxart, a South San Francisco, California-headquartered developer of oral recombinant protein vaccines, for the manufacture of Vaxart’s oral vaccine candidate for COVID-19.

Under the agreement, Kindred Biosciences will provide manufacturing services from its biological development and cGMP manufacturing facility in Burlingame, California. Kindred Biosciences will produce the bulk drug substance for the vaccine candidate under GMP and provide it to Vaxart to be formulated into a vaccine tablet. Kindred Biosciences will manufacture the vaccine for clinical trials beginning in the second half of 2020.

In January 2020, Vaxart initiated a program to develop a COVID-19 vaccine based on its VAAST oral vaccines platform. Vaxart has contracted with Kindred Biosciences and Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, to produce bulk vaccine under cGMP for upcoming clinical trials. The vaccine tablets will be manufactured at Vaxart.

Kindred Biosciences’ CDMO activities are managed by a wholly owned subsidiary, Centaur Biopharmaceutical Services.

Source: Kindred Biosciences and Vaxart

Formulation Development/Drug-Product Manufacturing

CordenPharma, Moderna in Pact for Lipid Excipients for COVID-19 Vaccine Candidate
CordenPharma, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has signed an amendment to its existing manufacturing agreement with Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, to enable CordenPharma to manufacture large-scale volumes of Moderna’s lipid excipients to be used in the manufacture of Moderna’s vaccine candidate (mRNA-1273) against SARS-CoV-2, the virus that causes COVID-19.

Under agreement, the companies will further extend their supply relationship by expanding the manufacturing agreement originally signed in 2016 between Moderna and CordenPhar­ma Switzerland. The amended agreement now includes CordenPharma Chenôve (France) and CordenPharma Colorado (US) for the manufacture of larger-scale volumes of lipids. The expanded agreement will begin immediately (as reported on May 28, 2020) in order to meet Moderna’s demand over the upcoming months, with an emphasis on securing future long-term supply.

Source: CordenPharma

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