The manufacturing agreement was initiated during the clinical development phase of the vaccine in Q1/2020. In the meantime, Biomay has become a formally qualified supplier for BioNTech. The scope of services includes process and analytical development, followed by GMP preparation of the cell bank, manufacturing of circular DNA plasmid and finally preparation of the linear DNA template.
In 2021, Biomay has produced and delivered multiple batches of released DNA template and supported the mRNA vaccine production thanks to this important manufacturing component, and the company will continue to do so throughout the year.
Hans Huber, Chief Executive Officer of Biomay, is pleased about Biomay cooperating with BioNTech on this globally essential project: “Biomay is proud to be making an active contribution to combating the coronavirus pandemic. Our staff are highly motivated and fully aware of the major responsibility associated with this cooperation. We would like to thank BioNTech for their trust in Biomay´s expertise. We have been able to demonstrate that our proprietary plasmid manufacturing platform is well suited to supply the required high quality and large volume of DNA template.”
About the Pfizer-BioNTech COVID-19 Vaccine
The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
Biomay AG is a biopharmaceutical contract development and manufacturing organization (CDMO) with an international reach. Biomay is recognized as a supplier of plasmid DNA (pDNA), recombinant proteins and mRNA. Biomay´s clients include start-ups, midsize biotech companies and multinational enterprises, predominantly from Europe and the US. Beside the manufacturing of active ingredients and drug products according to standards of Good Manufacturing Practice (GMP), the company offers process and assay development as well as manufacturing of microbial cell banks.
Biomay is currently constructing a fully integrated biotech manufacturing plant in Aspern Seestadt, Vienna. This greenfield investment will exclusively be dedicated to Biomay´s biotech CDMO activities. Parallel manufacturing lines will allow Biomay to increase its capacities by a factor of 10 with respect to batch scale and bioreactor volumes (rounded up to ~ 1000 L). Biomay will move to its new facility in December this year, with GMP operations scheduled to start in Q1/2022.