Why it's important
Inhouse production and storage of biomaterials can be labor-intensive and costly. Learn the top six reasons you should consider an outside expert such as ATCC for your critical biomaterials manufacturing and preservation.
1. Access to authenticated biologics. ATCC has over 5,000 cell lines in our collection of critical starting materials for the development and commercialization of pharmaceuticals and biologics. As the trusted global source for cell authentication and uncompromised quality, we set the benchmark for cells used in protein and viral manufacturing and testing applications.
2. Cell banking and storage expertise. For nearly a century, ATCC has been regarded as a pioneer in cell banking and storage, using the most reliable and standardized procedures and equipment to manufacture and preserve biomaterials.
3. Master and Working Cell Banks (MCBs and WCBs). We catalog the cell line history, production process, methods, reagents, and the in vitro cell age. The quality-controlled process reduces genetic drift and provides customers with a two-tiered cell bank system to ensure a common starting source for each product lot.
4. cGMP processes and facilities. ATCC supports multiple stages of the cell banking process, from initial development to master/working cell bank production runs in efforts to expedite your timelines while following current Good Manufacturing Practices (cGMP), 21 CFR 600, 610 biologic regulations.
5. Exemplary cGMP biorepository facilities: cGMP biorepository experts provide safe segregation of biological materials and can characterize, package, store, and distribute your biological materials to ensure the security and integrity of your cell banks. Our facilities include:
- ISO 9001:2015 and cGMP-compliance
- LN₂, -80°C, -20°C, and 2-8°C storage available
- Cell, microbe, protein, and nucleic acid storage options
- Safe segregation of all biological materials
- Cold-chain support and management
- On-call, after-hours personnel; 24/7 temperature monitoring
- Direct quality oversight of all unit entry and retrieval activities
6. Quality control release testing, including:
- Mycoplasma testing
- STR analysis, mouse
- CO1 assay
- Sterility testing
- Human pathogenic testing
- Other tests as required
Patrick J. Laverty, PhD
Vice President, Quality, Safety, and Product Compliance
Patrick leads ATCC’s compliance-focused teams, with emphasis on functional integration, strategic alignment, support of new product and growth initiatives, and compliance of regulatory needs and business process improvement.
How we can help
ATCC is approved under cGMP and takes the risk out of creating working and master cell banks.More
We have been the authority on cell and microbial banking for nearly 100 years. Our laboratory and storage facilities are first-in-class for the large-capacity storage of cell lines, microorganisms, and other biological materials. We can support any cell banking need and will work with you at all stages of the cell bank development process from the initiation of your project to the large-scale production of your cells and microbes.More
Read this white paper for an overview of the relationship between the evolving practices of modern biorepositories and the current trends in pharmaceutical R&D.More