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Throughout the development and release of a commercial product, a critical part of Chemistry, Manufacturing and Controls (CMC) is to establish the safety, identity, strength, quality and purity of your biologic. While we offer a complete range of CMC analytical capabilities to successfully support your biologic program, we specialize in the following:
- Safety testing
- Adventitious virus identification ─ Next Generation Sequencing (NGS) and bioinformatics
- Viral clearance testing
- Identity determination
- High-resolution MS
- Edman sequence analysis
- Amino acid analysis (AAA)
- Circular dichroism
- Strength/potency assessment
- Platform and custom assays─ ADCC, CDC and more
- In vivo USP hormone assays
- Quality testing
- GMP and non-GMP stability and release testing
- Purity determination
- Charge heterogeneity (CZE, IEX-HPLC, cIEF)
- Size heterogeneity (CE-SDS, SDS Page, SEC-HPLC)
