Brammer invests in commercial-ready gene therapies

By Flora Southey contact

- Last updated on GMT

iStock/mipan
iStock/mipan

Related tags: Food and drug administration

Brammer Bio says its commercial-scale gene therapy manufacturing facility in Cambridge, Massachusetts, US, will open in the second half of 2017.

The contract development and manufacturing organization (CDMO) said the site offers process development, clinical phase, and current Good Manufacturing Practices (cGMP) services for cell and gene therapies.

“We are delighted to add an experienced commercial biologics team and facilities to help meet the needs of this transformative industry,” ​said Mark Bamforth, CEO of Brammer.

Brammer has completed a Type-C meeting with the US Food and Drug Administration (FDA) to assess the plans for the Massachusetts-based site. A Type-C​ meeting regards the development and review of drugs or biological drug products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

A Site Master File will be submitted later this year to support Brammer’s clients’ product applications. 

The site originally housed Biogen’s clinical and commercial biologics manufacturing facility.

Brammer purchased it along with Biogen’s distribution center in Somerville, Massachusetts, on January 1, 2017.

The Somerville site offers Brammer nearby storage and distribution capabilities.

The announcement follows Brammer’s 2016 plans​ to renovate its 50,000 square-foot facility in Lexington, Massachusetts, to cater for late stage and commercial therapy supply.

Brammer’s facilities now offer 230,000 square feet of development, distribution and cGMP manufacturing capabilities across Florida and Massachusetts, US.

Related news

Show more

Related products

Microsampling in Early Phase Drug Development

Microsampling in Early Phase Drug Development

Altasciences | 10-May-2022 | Technical / White Paper

Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic...

Seasonal Vaccine Manufacturing

Seasonal Vaccine Manufacturing

Baxter BioPharma Solutions | 16-Feb-2022 | Technical / White Paper

The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...

Consideration and Options for Prefilled Syringes

Consideration and Options for Prefilled Syringes

Baxter BioPharma Solutions | 16-Feb-2022 | Technical / White Paper

Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the...

Partner with Experts in Precision Medicine

Partner with Experts in Precision Medicine

CellCarta | 17-Jan-2022 | Product Brochure

At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed...

Related suppliers

Follow us

Products

View more

Webinars