The Mainz, Germany-based biotech said it expects to produce up to 250 million doses of its proprietary vaccine at the site in the first half of this year and up to 750 million doses annually when production is fully ramped up.  The partners’ goal is to produce 1 billion doses during 2021. A single mRNA batch of the current scale is sufficient to produce around eight million vaccine dose, according to the company.

The first vaccines are expected to roll off the line at Marburg in early April. Explaining the process, BioNTech said that following mRNA production and purification, Lipid Nanoparticles (LNP) are formed by combining the genetic base product with a mixture of lipids. This is then sent to a CDMO partner for fill & finish.

When the current vaccine-focused process is complete, an analysis to confirm quality of the final product is to be conducted by two independent laboratories, BioNTech’s quality control lab in Idar-Oberstein, Germany, and the official medicinal batch lab at Germany’s Paul-Ehrlich-Institute in Langen, Germany.

Under Novartis, the Marburg plant had initially manufactured vaccines for rabies, swine flu, and tetanus – a line the Swiss group gave up in a portfolio swap with GlaxoSmithKline. However, it retained the premises, which at the time of sale to BioNTech employed 300 skilled workers making complex biological medicines. The site also had two bioreactors that could be retrofitted to produce the Covid vaccine.

After a review of quality and validation data, the next step in the BioNTech effort calls for the production process to be approved by the European Medicines Agency (EMA). Data from the first batches as well as from process validation will be assessed via the centralized variation procedure coordinated by the EMA. This is due to take place during February and March.

Evonik steps in with lipid production

Following Merck, KGaA, which last week said it would “significantly accelerate” the supply of urgently needed lipids to BionTech at Mainz and increase the volume of deliveries up to the end of 2021,  another German chemical producer – this time, Evonik – announced plans to ramp up its lipids production to help produce mRNA vaccines.

In what it called a “long –term investment,” the Essen-based group said it will begin making commercial volumes of lipids at its Hanau and Dossenheim, Germany, sites from the second half of 2021 as part of a strategic partnership with BioNTech.

As a leader for advanced drug delivery, Evonik said it supports drugmakers worldwide in development and production of complex parenteral drug products that require formulation technologies, including lipid nanoparticles. During the pandemic, the chemical group has been actively involved in various mRNA-based vaccines projects for Covid-19, supplying excipients such as lipids, as well as CDMO services.

The specialty chemical producer, which has steadily expanded its market presence through acquisition, already develops and formulates lipid nanoparticles in Burnaby, Canada, and additionally operates a facility for the production and fill & finish of commercial volumes at Birmingham, Alabama, in the US.

German pressure group calls for BioNTech knowhow leak

A German pressure group calling itself Peng (bang as in gunshot) has started a campaign called Biontech-Links, calling on company employees to steal the formula for making the Covid vaccine and leak it publicly. In this way, the campaign says, other firms can make it and thus increase supply to the 60 or so countries that have not yet begun vaccinating their population.

A spokesperson for Peng said BioNTech’s vaccine was developed with “generous public funding,” but as a privately owned company it is now holding it under wraps, thus enabling an unjust distribution and contributing to supply bottlenecks. Peng, which has bought large-scale advertising displays in public places and made a film urging the leak, called on the political sector to remove the Mainz-based biotech’s patent production.

Author: Dede Williams, Freelance Journalist