Selvita offers broad range of integrated analytical testing solutions for biopharmaceuticals. Our approach enables biosimilars to reach the global market in prompt and safe manner. We test commercial batches against the specification under strict cGMP compliance, confirmed by QP.
Our broad capabilities allow to test the product at one site, including characteristics, assays, identity, purity, safety, excipient analysis:
- Compendial testing (physicochemical properties)
- Chemical and functional testing (identity e.g., SDS-PAGE non reduced and reduced, purity, cell-based bioassay for potency, protein concentration, Tween/m-Cresol/Polysorbate content)
- Microbiological testing (sterility, BET)
- Working Cell Banks generation in accordance with USP <1032>
Our services quality has been repeatedly confirmed during the cGMP inspections, which prove that services provided by Selvita are performed according to the highest standards and relevant guidelines of pharmaceutical industry.
Our QC Laboratory constantly expands its capacity to release large volume of testing, in line with production schedules and in timely manner. Selvita is EU commercial testing laboratory for several big pharma operating worldwide.