(Vienna) Biomay, a Vienna based mostly biotech producer, in the present day introduced their partnership with BioNTech SE to assist the provision chain for manufacturing of the Pfizer-BioNTech COVID-19 mRNA vaccine. Biomay is without doubt one of the producers supplying BioNTech with the DNA template for the in-vitro transcription of their mRNA energetic ingredient.
The manufacturing settlement was initiated in the course of the scientific improvement part of the vaccine in Q1/2020. Within the meantime, Biomay has change into a formally certified provider for BioNTech. The scope of providers consists of course of and analytical improvement, adopted by GMP preparation of the cell financial institution, manufacturing of round DNA plasmid and eventually preparation of the linear DNA template.
In 2021, Biomay has produced and delivered a number of batches of launched DNA template and supported the mRNA vaccine manufacturing due to this necessary manufacturing element, and the corporate will proceed to take action all year long.
Hans Huber, Chief Government Officer of Biomay, is happy about Biomay cooperating with BioNTech on this globally important mission: “Biomay is proud to be making an energetic contribution to combating the coronavirus pandemic. Our employees are extremely motivated and absolutely conscious of the key duty related to this cooperation. We wish to thank BioNTech for his or her belief in Biomay’s experience. Now we have been in a position to show that our proprietary plasmid manufacturing platform is nicely suited to provide the required top quality and huge quantity of DNA template.”
Concerning the Pfizer-BioNTech COVID-19 Vaccine
The Pfizer-BioNTech COVID-19 vaccine, which relies on BioNTech proprietary mRNA know-how, was developed by each BioNTech and Pfizer. BioNTech is the Advertising Authorization Holder within the European Union, and the holder of emergency use authorizations or equal in the USA (collectively with Pfizer), United Kingdom, Canada and different nations prematurely of a deliberate utility for full advertising authorizations in these nations.
Biomay AG is a biopharmaceutical contract improvement and manufacturing group (CDMO) with a world attain. Biomay is acknowledged as a provider of plasmid DNA (pDNA), recombinant proteins and mRNA. Biomay’s purchasers embody start-ups, midsize biotech firms and multinational enterprises, predominantly from Europe and the US. Beside the manufacturing of energetic substances and drug merchandise in line with requirements of Good Manufacturing Apply (GMP), the corporate affords course of and assay improvement in addition to manufacturing of microbial cell banks.
Biomay is presently setting up a completely built-in biotech manufacturing plant in Aspern Seestadt, Vienna. This greenfield funding will completely be devoted to Biomay’s biotech CDMO actions. Parallel manufacturing traces will enable Biomay to extend its capacities by an element of 10 with respect to batch scale and bioreactor volumes (rounded as much as ~ 1000 L). Biomay will transfer to its new facility in December this yr, with GMP operations scheduled to start out in Q1/2022.