New process development

When you have a promising biological drug candidate, getting to the clinic fast with a product that is pure, safe, and effective is critical. Implementing efficient analytical methods along the way to monitor and minimize product- and process-related impurities is vital to optimize the purification process and achieve the desired drug substance yield. 

For over 25 years, biomanufacturers across the globe have relied on Cygnus to assess the purity and safety of their therapeutic antibodies, proteins, gene therapies, and vaccines prior to human trials, regulatory approval and commercial release. Our scientists have decades of experience developing best-in-class immunoassays for Host Cell Proteins (HCP) and other process-related impurities (resin leachates, media components, and processing enzymes) that are highly trusted by industry and regulatory agencies.