Contract development and manufacturing organisation (CDMO) Rentschler Biopharma will serve as a manufacturing partner for BioNTech to help produce the company’s collaborative Covid-19 vaccine - BNT162b2.
Covid-19
The agreement will have Rentschler Biopharma be responsible for downstream processing to provide highly purified drug substance. Process and product-related impurities will be effectively removed from the intermediate pool, which has been previously derived from mRNA synthesis. This step is important for ensuring that the vaccine is safe and can be tolerated for use in humans. At the same time, it maximises the amount of mRNA harvested from initial production. Rentschler Biopharma will produce purified drug substance at its headquarters in Laupheim, Germany.
Dr Frank Mathias, CEO of Rentschler Biopharma, said: “We are honoured to contribute to BioNTech’s ‘Project Lightspeed’ and their work in developing this highly innovative mRNA vaccine. To tackle the Covid-19 pandemic, it is critical to bring high-quality, safe and effective vaccines to the public quickly and on a large scale. At Rentschler Biopharma, we feel it is important to do our part in combatting this virus. As a cGMP service provider with more than 40 years of proven manufacturing expertise, we are well suited to work with BioNTech to make their ground-breaking science a medical reality and will work tirelessly to this end.”
In addition to the large-scale production services for the Covid-19 vaccine, the agreement will also see Rentschler Biopharma providing small-batch manufacturing for BioNTech’s other RNA programmes for use in clinical trials.
BNT162b2 is an mRNA-based vaccine that is being developed between Pfzier and BioNTech, and which is currently in a global Phase 3 clinical trial. The vaccine is currently in what is called a ‘rolling review’ by the European Medicines Agency (EMA’s), which is designed to speed up the assessment process for what are considered promising medicines during a public health emergency. The EMA’s human medicines committee (CHMP) is reviewing data from the vaccine as they become available, whereas usually safety and efficacy data are submitted before a formal application for market authorisation is made.