BioNTech heads down under to build mRNA plant

BioNTech has entered into a partnership with the State of Victoria, Australia to construct a research and manufacturing center for mRNA-based products in Melbourne.

According to the German biopharma company, the center will support “discovery to delivery” of messenger RNA (mRNA) vaccines and therapies. Additionally, as part of the collaboration, BioNTech will construct a BioNTainer facility for clinical scale manufacturing of mRNA-based products and candidates.

A BioNTainer is a cleanroom built from six ISO sized containers and consisting of one drug substance and one formulation module, which the firm says enables mRNA vaccine production in bulk. This is not the first time the firm has announced a BioNTainer-based mRNA production plan. In February, BioNTech introduced a container solution for its mRNA manufacturing strategy to improve vaccine supply in Africa.

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“Science and innovation can only make a difference if it is applied outside of the laboratories and reaches people worldwide. This partnership is a major step forward to enable access to mRNA technology and promote collaborations in the Asia-Pacific region,” said Ugur Sahin, CEO of BioNTech.

“Australia provides excellent academic research, and we are looking forward to collaborating with world-class scientists and researchers to strengthen Australia’s mRNA ecosystem and to jointly develop potential novel treatments and vaccines for people worldwide.”

In December 2021, Moderna announced plans to build an mRNA vaccine plant in Victoria Australia, which could produce up to 100 million doses each year.

Clinical testing  

BioNTech says that the flexible modular production unit requires little space for operation, meaning that Australia would have access to timely and flexible production of various mRNA-based products across a wide range of indications.

The BioNTainer solution in Melbourne will also be used to run clinical testing of product candidates. BioNTech claims it has 18 product candidates in 23 clinical trials, including two Phase II mRNA-based product candidates in Australia named BNT111 and BNT113 that it is currently recruiting cancer patients for.

In addition, the firm says BNT211, an autologous chimeric antigen receptor (CAR) T cell therapy combined with an mRNA vaccine will also be included in the plans to expand clinical development.

“We at BioNTech are committed to global public health, and as we continue to expand internationally, we look forward to working jointly to drive the development of innovative medicines,” said Sierk Poetting, COO of BioNTech.

“Our BioNTainers are designed as turnkey manufacturing sites for mRNA-based medicines and product candidates. In Melbourne, our BioNTainers will allow for an end-to-end production including fill and finish for clinical-scale manufacturing of mRNA candidates, once approved.”

While specific numbers have not been disclosed, BioNTech also said that it anticipates the facility to create hundreds of jobs during construction and operation in Melbourne.