Development of biologics is a high stakes/ high reward business. Get your preclinical/clinical assessments from your Covance team. Covance scrutinizes safety carefully because therapeutic proteins, antibodies and recombinant proteins often cause production of anti-drug antibodies (ADA). That can jeopardize your patient's safety. Ensure you are doing everything possible to assess safety and efficacy with immunogenicity services provided by Covance.
Thorough immunogenicity assessment of a biopharmaceutical drug's immunogenic potential is recommended by the EMEA, FDA and other regulatory agencies. You gain instant expertise with the 30 years of insight Covance brings to the construction and implementation of a four-step immunogenicity testing strategy:
- Titer assessment
- Cell-based neutralizing antibody detection