Therapeutic Proteins and Peptides
Quality Systems supports the development, manufacturing and testing of Therapeutic Proteins, including Monoclonal Antibodies, Fusion Proteins and Peptide-based Vaccines. We have identified and established proven, reliable partners in cell line development, characterization, synthesis and manufacturing, release and stability testing across the US, Europe and Asia. We can outline product development strategies and are able to tailor our services over a spectrum of needs, and from turnkey delivery of a CMC section for an IND, to creating GMP/GLP capabilities within an organization to facilitate development, to project management, to addressing specific challenges including facility design and validation to process development. Our broad experience over a wide array of therapeutic products, as well as hands on management details critical to quality and regulatory compliance, assures the earliest possible entry into Phase I/II trials.
First to Phase I
Contact us to learn how we can help get your therapeutic protein into Phase I clinical trials cost effectively, in the shortest possible time.
EMEA Revised Guideline on Monoclonal Antibodies