Services

Master and Working Cell Bank Production (cGMP)

Master Cell Banks (MCB) and Working Cell Banks (WCB) are manufactured and tested in compliance with cGMP regulations.

Cell banks are manufactured in a dedicated ISO 7 cell banking room. The cell banking module contains two spatially segregated rooms with its own gowning and degowning space. All cell banks are stored in validated ultra-low freezers that are monitored 24/7 by a validated monitoring system.

Typically, we produce 200 vials of the MCB or WCB for our clients. To better protect the cell bank, we offer long-term storage options at our facility. In addition, a portion of the MCB vials can be stored at an offsite commercial cGMP compliant storage facility.

Cell Line Authentication, Sterility, and Characterization
Prior to manufacturing of a target biologic, the MCB and WCB are tested and characterized in accordance with FDA and European regulatory agency requirements. These include microbial contamination, cell line authenticity, and in vitro and in vivo adventitious and endogenous viral tests.
Cell Therapy Products
Our highly experienced cell culture scientists are capable of processing allogeneic, parenteral products for cell therapy.

Please contact us for more information. Project specific proposals are provided upon request.