Keeping tabs on Covid-19: BioNTech buys GMP-certified facility to boost vaccine production and new specimen collection kit decreases Covid-19 testing turnaround times

News of a deal between BioNTech and Novartis has circulated the news sheets this week as the German biotech firms hopes to increase its Covid-19 vaccine production to produce up to 750 million does per year

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This week Pharma IQ looks at how the pharma industry is expanding its vaccine manufacturing and testing protocols to ensure the deadly Covid-19 outbreak yields in its spread around the globe. 

Read on to discover how big pharma is preparing to deliver a cure for coronavirus.

BioNTech acquires Novartis GMP manufacturing site to expand Covid-19 vaccine production

BioNTech has agreed to buy a Novartis manufacturing facility in Marbury, Germany, to expand its Covid-19 vaccine production capacity by up to 750 million doses per year, or more than 60 million doses per month, once fully operational.

The acquisition is expected to accelerate BioNTech’s efforts to scale-up its commercial manufacturing capacity to produce its mRNA Covid-19 vaccine candidate BNT162 in collaboration with Pfizer. The BNT162 program includes five mRNA vaccine candidates currently in clinical testing in the US, Europe, South America and China.

The Marburg facility is expected to start the production of mRNA formulation for a Covid-19 vaccine in the first half of 2021, pending regulatory authorization or approval. BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccines, antibody and cell and gene therapy candidates to support the development of its diversified cancer and infectious disease product pipeline.

In addition, BioNTech said it intended to use the Marburg facility to contribute to the production of the Covid-19 vaccine for global supply, including to China where it has partnered with Fosun Pharma, subject to regulatory approval.

Dr. Sierk Poetting, chief financial officer and chief operating officer at BioNTech, said: “This acquisition reflects BioNTech’s commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorization or approval. We are working closely with Novartis to prepare for a smooth transition.

“The new site will bolster our vertically integrated business model with in-house manufacturing capabilities for mRNA manufacturing as well as vaccine formulation.”

BioNTech and Novartis have anticipated completing the transaction in the fourth quarter of 2020, subject to regulatory approval and the satisfaction of certain other customary closing conditions.

Vivera Pharmaceutical provides Covid-19 results within 48 hours of initial patient test

Vivera Pharmaceuticals, Inc. has partnered with OmeCare, a CLIA-certified global clinical laboratory provider, to launch a new diagnostic test solution for Covid-19.

The Vivera Pharmaceuticals and OmeCare rRT-PCR specimen collection kits are available for use by medical providers. The quick, painless swab utilizes specimens collected from either the nose or mouth. Once collected, the sample is sent overnight to the OmeCare laboratory for processing and results are sent back to medical providers in less than 48 hours, eliminating excessive wait times for testing a large number of patients with Covid-19.

Olivia Karpinski, vice-president of sales at Vivera Pharmaceuticals, said: “We have worked closely with our customers, including long-term care facilities and hospital networks, to provide efficient solutions for their increased testing needs."

Dr. Michael Nova, MD, PhD, chief of innovation at OmeCare, commented: “rRT-PCR is the gold standard for detecting Covid-19, and OmeCare employs the most advanced and cost-effective microfluidic technologies that increase sensitivity, decrease turnaround times and simultaneously assay for additional respiratory viruses.”

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