Translate Bio, Sanofi secure CDMO capacity for potential COVID-19 mRNA vaccine

Sanofi has become the latest firm to leverage mRNA vaccine technology to tackle COVID-19. Its partner Translate Bio, meanwhile, has secured dedicated manufacturing capacity at AMRI to respond to the potential global demand.

France’s Sanofi Pasteur announced it is extending an alliance formed in 2018 with Translate Bio specifically to target the novel coronavirus (COVID-19).

Translate is already producing multiple mRNA constructs through its MRT platform, and now the platform will be used to discover, design and manufacture a number of vaccine candidates to fight COVID-19. Sanofi – which has already upped its recombinant vaccine efforts to take on COVID-19 –  will look to move these candidates rapidly through development.

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Translate Bio uses its MRT platform aims to create mRNA that provides a set of instructions to create functional proteins, and designs nanoparticles to deliver the mRNA to a patient’s cell. “From there, the cell’s own machinery translates it/reads the message, restoring protein function,” Ron Renaud, CEO of Translate Bio, told Bioprocess Insider.

The firm has a broad pipeline of mRNA therapies and vaccines and has a multi-year strategic agreement with contract development and manufacturing organization (CDMO) Albany Molecular Research, Inc. (AMRI) in place to support clinical production and – if Translate and Sanofi’s efforts are fruitful – beyond.

“Related to global demand, depending on the dose of the vaccine, we would be able to make multi-millions of doses at our current manufacturing scale of 100 gram single-batch production capacity,” said Renaud.

“We will be able to supply even greater quantities with the planned dedicated manufacturing space being built at AMRI that can accommodate multiple 250g batches per month, and we expect that space to be online later this year.”

Has mRNA tech finally blossomed?

Messenger RNA (mRNA), a genetic technology intended to coax the body’s cells into producing proteins that treat a disease or spark immunity to one, has been proposed for vaccines and therapeutics since the beginning of the biotech era. However, the technology has always played second fiddle to other biotechnologies such as monoclonal antibodies and even cell and gene therapies.

But with the arrival of COVID-19, industry has turned to this unproven technology to provide a potential vaccine.

“mRNA vaccines represent a potentially innovative alternative to conventional vaccine approaches for several reasons,” explained Renaud. “Their high potency, ability to initiate protein production without the need for nuclear entry, capacity for rapid development and potential for low-cost manufacture and safe administration using non-viral delivery.

“This approach potentially enables the development of vaccines for disease areas where vaccination is not a viable option today. Additionally, a desired antigen or multiple antigens can be expressed from mRNA without the need to adjust the production process offering maximum flexibility and efficiency in development.”

mRNA, Moderna and industry’s renewed interest

Moderna Therapeutics has been at the frontline of mRNA. From an investment standpoint, the firm has garnered billions in fundraising efforts since its creation in 2010 and raised $604 million in its initial public offering (IPO) in 2018. And from a development standpoint, the firm has a broad pipeline of vaccine candidates looking to prevent cancers and infectious diseases.

The company was also quick off the mark in moving an mRNA vaccine candidate into the clinic for COVID-19.

Pfizer, meanwhile, has teamed up with Germany’s BioNTech to develop a COVID-19 vaccine based on mRNA technology. Another Germany-based company CureVac is looking to begin clinical trials of its mRNA vaccine candidate in the summer.

And last week, Belgium’s eTheRNA Immunotherapies launched a consortium to use its mRNA TriMix platform to develop an intranasal vaccine against COVID-19 with EpiVax, Nexelis, REPROCELL and CEV.