Large Molecule Services

Biological drug development requires a set of specialties different from traditional chemically synthesized small molecule drugs. Its regulatory environment is also more dynamic. To achieve your objectives, Covance BioPharmaceutical CMC Solutions provide you with a large multidisciplinary global team of experts equipped with purpose-built infrastructure to perform studies that meet all regulatory and quality requirements. With over 250 different biomolecules successfully supported annually, we now offer you the most comprehensive service in the industry.

As the partner of choice for clients ranging from large to small companies in the biopharmaceutical industry, Covance recognizes that your development program is as unique as the biologic you bring to our facilities, and we strive to provide the customized service you need. Develop, characterize, test and validate with Covance, no matter what technique or molecule you're pursuing. Our experience covers a wide range of biomolecules, including monoclonal antibodies, recombinant proteins, vaccines, biosimilars, blood products, gene therapy products and more.

Quality compliance:

  • GLP, GMP, ISO9001 
  • Inspected by MCA, FDA, MHRA for regulatory compliance 
  • Regularly inspected by clients 

Regulatory compliance:

  • Europe, North America, Japan 
  • The International Conference on Harmonisation (ICH) 

Customized and committed to clients large or small, Covance recognizes your development program is as unique as the products you bring to our facilities. Streamline testing requirements conform to the latest regulatory guidelines, and satisfy regulatory and quality compliance statutes with Covance.

For small molecule CMC solutions, please click here

Biomolecules

Let us know your agent type and we will design a program tailored for you:

Biosimilars Webinar

Learn more about the nonclinical and clinical development challenges and considerations for biosimilars.

State-of-the-Art-Facilities

Take a virtual tour of our Greenfield, Indiana, US facility.