Cell banking is integral to the development and commercial production of biologics. Cells are used to express therapeutic proteins such as monoclonal antibodies and to propagate viruses used for both live-attenuated and inactivated vaccines. More recent advances in the area of cell and gene therapy also rely on a consistent source of cells, such as for stem and allogeneic cell therapies, or for the preparation and propagation of virus vectors for gene therapy.
The number of companies with biologics programs has grown over the past several years and the demand for cell banking has increased with that growth. Due to this, and coupled with the rise of cell and gene therapy products in development, the lead time to produce a cell bank in outsourcing facilities has become longer.
We are responding to this increased need with the upgrade and expansion of cell banking services at our Malvern, PA site, which currently manufactures cGMP-compliant microbial and animal cell banks as well as virus and vaccine related products. The construction of 2,800 sq. ft. of new, state-of-the-art clean rooms dedicated to cGMP manufacturing is currently in progress. The project will increase animal cell banking capacity by 60%, as well as upgrade rooms for virus and vaccine production. In addition to the facility expansion, we will be adding capabilities for high-volume and/or high-density cell banks to meet the needs of companies requiring alternatives to traditional cell bank formats.
The new manufacturing space is expected to be validated and operational by April 2018. If you have questions about the facility or would like to inquire about cell bank or virus manufacturing for your particular product, please contact us at [email protected].