Diagnostic, potency, extraneous agent, proof-of-inactivation, and in-process testing methods for viral, bacterial, and antibody products.

Isolation, characterization, and cloning of pre-master seeds & cell stocks with appropriate reagents and documentation for regulatory risk reduction.

Coordination of hybridoma generation, isotyping, mAb specificity testing, mAb production and purification.

Sample processing and testing for pre-screening and in-study samples. Serology, titer determination, bacteria/virus isolation, and molecular-based testing.

In vitro discovery and proof-of-concept work, sample testing for stability, duration-of-immunity, reference qualification and requalification - bring your requirements, and let’s discuss them!