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Biopharmaceutical Services

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, including GLP, GMP, ISO9001, MCA, FDA, MHRA, ICH, and satisfy regulatory and quality compliance statutes with Covance. With over 250 different molecules successfully supported annually, we now offer you the most comprehensive service in the industry.

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 recombinant proteins, monoclonal antibodies, vaccines, blood products, gene therapy products and more.

Our capabilities include protein analytical chemistry, immunocharacterization, cell banking, biosafety testing, viral clearance, bioassay studies, molecular biology, stability and release, biomanufacturing support and more.

Contact Covance representative at ji.wu@covance.com

Manufacturer Covance
Product Type Service
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Bioassay Services Built on a track record of success, Covance delivers smooth bioassay development experience with hundreds of bioassays each year

Biopharmaceutical Services Customized and committed to clients large or small, Covance recognizes your development program is as unique as the

cGMP Cell Banking Services Covance offers complete cGMP master (MCB) and working (WCB) cell bank generation, storage and cell line biosafety testing.

cGMP Stability and Release Testing Covance offers cGMP-compliant stability and release services for both large and small molecule drug API and drug

cGMP Testing of Extractables and Leachables The FDA Guidance defines leachables and extractables as materials or components derived from the

cGMP Testing of Inhaled Products Inhalation products pose certain development challenges. Improve opportunities to assess inhalation products with

CMC Analytical and Development Services Covance provides industry-leading CMC Analytical and Development Services. Our capabilities and capacity have

CMC Method Development and Validation The FDA Guidance defines leachables and extractables as materials or components derived from the

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Stability Studies Research Library

Analytical Considerations in Formulation
Covance 		Formulation is arguably the most critical—and challenging—component of biopharmaceutical drug development, second only to the molecule itself. Formulation's far-reaching consequences help sponsors satisfy the scientific, medical, and regulatory conditions for drug approval and, subsequently, support marketplace success. A biopharmaceutical formulation consists of active pharmaceutical ...
 
Vaccines: The Path to Immunity
Covance 		Historically, vaccines are medicines that deliver or generate antigens that induce specic, active, and protective immunity against infectious diseases. Antigens stimulate the immune system to activate cells and organs that induce active immunity, characterized by production of antibodies (humoral immunity) and/or cytotoxic T-cells (cell mediated immunity). Vaccines “train” the body’s immune ...
 
Leveraging the Size and Scope of Global CRO's: The Virtual Advantage
Covance 		Biotech was “born” in the 1970s. Since that time innovation by biotech pioneers has brought more than 200 medicines and vaccines to fruition for difficult-to-treat indications including oncology, HIV/ AIDs, diabetes, and immune disorders. Biotech is poised to capitalize on the current challenges confronting Big Pharma: looming patent expirations on blockbuster medicines and a dearth of new ...
 
Bioanalysis & Drug Metabolism: Charting the Shifts in Scientific and Regulatory Issues
Covance 		Conducting comprehensive metabolism studies has long been an essential component of a preclinical drug development program. However, numerous factors — including the increased development of protein-derived drugs and the expanded interest in the role of metabolites in safety assessment — are having a significant impact on the regulatory mandates, scope of studies and methodologies employed. In ...
 
Key Factors in the Safety Assessment of High-Risk Medicines
Covance 		In March 2006, six normal healthy volunteers participating in a clinical study in the UK were given an intravenous (IV) dose of an experimental immuno therapeutic as a part of an ascending single dose safety and tolerability study. Within a few hours of drug administration, all subjects exhibited severe reactions which progressed to multiple organ failure. As a result of the incident, regulatory ...
 

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