Protein Therapies Testing

From Cell Line to Rapid Lot Release

Supporting manufacturers of monoclonal antibodies, recombinant DNA derived, peptides, and combination products with testing services for protein therapies that cover the entire development cycle and satisfy global regulatory standards for biosafety.

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CLC + TEM

Not only do we offer a cell bank platform for faster GMP production and release, but we also provide comprehensive Cell Line Characterization utilizing TEM, ELISA, and PCR methods.

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Viral Clearance

Demonstrate to the regulatory bodies that your downstream process effectively removes/inactivates potentially harmful viruses in fewer steps with our tailored approach to viral clearance validation.

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Rapid Lot Release

Rapid Lot Release Testing Programs for unprocessed bulk, purified bulk, and final product keeps your timelines on track.

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Materials Characterization

Understand material properties and behaviors through quantitative and qualitative analysis.

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Extractables and Leachables

We enable you to conduct accurate risk assessments through complete characterization of all chemical compounds your product was exposed to during the manufacturing process with our multi-tiered extractables and leachables study program

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Not sure what testing service is right for you?

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Adding cell and gene therapies to your pipeline?

Learn more about our integrated manufacturing and testing service platform designed to accelerate development timelines.

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