Analytical Characterization Services for Biologics & Biosimilars
Biofidus is your bioanalytical laboratory of choice for fast, reliable analytical services for biologics and biosimilars, from early discovery through preclinical and clinical development. We support start-ups, biotechs and big pharma across the entire biologic development cycle, including cell and gene therapeutics, with a strong focus on CMC and regulatory expectations.
Our mission is to accelerate your development by providing tailored, in-depth characterization of your biopharmaceutical product and by helping you ask, and answer, the right CMC questions for agencies such as FDA and EMA. We design analytical programs around critical quality attributes (CQAs) that define identity, purity, potency, safety and stability, always following the principle: As much as necessary, as little as possible.
Drawing on decades of combined experience in mass spectrometry, chromatography, sequencing, electrophoresis and cell-based assays, our team has worked on hundreds of biologics and biosimilars projects. From routine high-throughput analysis to complex comparability and biosimilarity studies, we build fit-for-purpose, regulator-ready analytical packages that de-risk your CMC strategy, process changes and lifecycle management.
Get in contact with us to find the optimal strategy for your request and to speak directly from scientist to scientist.
