GLP Monoclonal Antibody and Protein Production
Our cost-effective, custom cell culture services platform utilizes our specialized cell culture facility, resources, and expertise to perform as an extension of your laboratory or your organization’s core facility. During our 30+ year history, we have worked with more than 2,650 cell lines in suspension or monolayer cultures. This includes common cell lines such as HeLa, CHO, Hybridoma, blood lines, MDCK, Vero, and HEK293, as well as custom cell lines supplied by researchers.
We have a well-established, robust system to allow your cell line to be received into our manufacturing facility for expansion. This system ensures that we protect the name of your cell line and perform screening to certify that the cells are safe to work with in our production area. This level of control also protects the safety of your cell line from all other clients’ cell lines sent to C3 for manufacturing.
Our minimum order quantities for whole cells are the following:
- Suspension cells: 10 liters
- Adherent cells: 10 roller bottles
- Antibody or other protein: 100 mg
Typical cell yields for one liter of suspension cell culture is ~5-10E8 cells. For adherent lines, one roller bottle typically yields 1-4E8 cells (within the 1,000 cm2 area). Final cell quantities will vary depending on the performance of the individual cell line.
At C3, we can culture from 10 to 400 liters of suspension cells and from 10 to 200 roller bottles of adherent cells. We also offer large-scale (i.e., 100 mg -100 g) production of purified monoclonal antibody.
Every cell line NC3 receives is individually handled using dedicated equipment and supplies. We follow standard operating and validation procedures and strict quality control methods that are similar to those outlined for Quality Systems Regulation (QSR). Additionally, our QSR covers personnel training, documentation, facility and equipment, Quality Control (QC), production and distribution procedures.
Finally, all culture work C3 completes using your unique cell line is confidential. No other customers have access to your cell line or cell-derived products. When your project is complete, C3 can return all your cell line materials, store a sample at the NC3, or specify that all supplied materials be destroyed immediately.