Gritgen Therapeutics has launched operations at its commercial GMP facility in Suzhou Industrial Park, China.

Gritgen will begin production of AAV [adeno-associated virus]-based products including its Phase III clinical and commercial product for haemophilia A.

The 8,600m² facility covers plasmid production and AAV production lines.

The production lines are based on a downstream process with chromatography platform technology and an upstream process with mammalian cell suspension.

They are equipped with disposable bioreactors of varying scales, the largest with the highest capacity of 1,000 litres.

The facility also features pilot filling lines and commercial fill-finish lines to meet the needs of drug manufacturers.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

A quality control laboratory covering physicochemical, biochemical, molecular biological and microbiological tests is also available.

Production lines in the facility are completely physically separated, controlling cross-contamination risk.

Gritgen Therapeutics co-founder and CEO Dr Wu Fenglan stated: “The validation and operational launch of our GMP facility represents a pivotal juncture for Gritgen, which provides an important vector foundation for the company to realise commercialisation.

“At present, a bottleneck of gene therapy is the manufacturing process, a challenge resonating globally.

“The production capacity of large-scale, high-quality, cost-controllable vectors is an important driving force for the development of the gene therapy industry.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.