Envigo understands that a different approach is required to achieve regulatory approval of biologics than that taken for small chemical drugs. To support this, we have a Chief Scientific Officer of Biologics and a team of EU and US based Directors of Biopharmaceutical Development who work with customers and operational departments to ensure developmental objectives are met.
The Biologics Product Development team possess over 50 years collective experience of biologics product development (vaccines, recombinant proteins; monoclonal antibodies; peptides, oligonucleotides; viral and non-viral gene delivery systems; and cell-based therapies) gained whilst working in small to large pharmaceutical companies (biotech to big pharma) and within the CRO industry. The team design packages on a case-by-case basis, reliant on a detailed understanding of the product and its mechanism of action thereby ensuring that the most appropriate data is obtained to a regulatory acceptable standard within the shortest feasible time frame.
Additionally this team is supported by a wide range of consultancy teams that can be called upon to provide up to date expert advice including; toxicologists, pathologists, immunologists, pharmacologists and biochemists.