CDMO Rentschler will be responsible for downstream processing of batches of Pfizer/BioNTech’s COVID-19 vaccine candidate BNT162b2 from its site in Laupheim, Germany.
BNT162b2 is one of the frontrunners in the race to develop a vaccine against COVID-19. The Phase III candidate is based on messenger RNA (mRNA) and being produced at several facilities in Germany run by developer BioNTech.
But now BioNTech and its partner Pfizer have selected contract development and manufacturing organization (CDMO) Rentschler to support production as it looks towards commercialization.
Image: iStock/pxel66
Specifically, Rentschler Biopharma will be responsible for downstream processing, removing impurities from the intermediate pool, which has been previously derived from mRNA synthesis – a key step in ensuring the safety and tolerability of a vaccine for use in humans.
While BNT162b2 is based on mRNA, Rentschler told us the purification uses similar or partly identical technologies and unit operations to other biopharmaceutical products.
“This is why Rentschler could seamlessly apply our existing extensive experience and expertise of over 40 years to quickly supply a high-quality cGMP mRNA drug substance,” a spokesperson said.
Thus after the mRNA is produced in a bioreactor from a template DNA via a synthetic, cell-free process, Rentschler separates process and product-related impurities to create the cGMP drug substance, before it is packed into lipid nanoparticles for targeted delivery and to prevent degradation within the human body. The mRNA vaccine is filled into vials that are labelled and undergo a quality control check before they are packaged for global distribution.
“We have in place an innovative business model that is well suited for novel, urgently needed technologies and allows maximum flexibility to address their development and manufacturing requirements,” a spokesperson said. “With BioNTech, this includes a dedicated mRNA suite at Rentschler Biopharma’s Laupheim, Germany facility.”
This is not the only COVID-19 project Rentschler is working on, though others have not been divulged.