Merck
HomeServicesTestingRaw Material Testing

Raw Material Testing

We offer a wide range of test services to ensure raw material quality and purity in cell banks, seed viruses, and finished products

Use of animal-derived products in biologics development or manufacturing creates an inherent risk of adventitious agent contamination in historic cell banks, seed viruses, and finished products. We offer a wide range of testing services aimed at ensuring the quality and purity of your raw materials, including:

  • Sterility testing
  • Mycoplasma detection assays
  • Adventitious virus testing/virology testing
  • Residual DNA testing
  • Endotoxin detection, LAL test
  • Bioburden testing
  • Bovine and porcine raw materials
  • Next Generation Sequencing

To discuss your raw material testing needs with an expert, use our reply form and get in touch today.

Related Product Resources

Application Note: Cell and Gene Therapy Definitions for Raw Materials, Starting Materials, Drug Substance and Drug Product
Poster: Mitigating the Risk of Zika Virus Contamination of Raw Materials & Vaccines by In Vitro Assays
Poster: An in vitro assay for detection of adventitious viruses of Ovine and Caprine origin in raw materials used in the production of biopharmaceuticals for use in humans

Request Information

Related Services

Bulk Harvest Release Testing
Whether you’re preparing for first-in-human clinical trials or scaling up for global distribution of a life-changing therapeutic biologic, our cGMP-compliant bulk harvest release testing services protect your investment at every step.
Final Product Release Testing
With all biologics released into global pharmaceutical markets requiring GMP testing of final product, we offer a wide range of assays and lot release testing services to help you demonstrate compliance with regulatory guidelines.

Related Applications

Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
Gene Therapy Manufacturing
Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
Cell Therapy Manufacturing
Introducing a new cell therapy demands optimal performance in upstream and downstream processing, process development, testing, and manufacturing. World-class products and partners are critical to success, speeding advancement of therapeutics that are effective, safe, and affordable.
Vaccine Manufacturing
From early phase development, through downstream purification to large scale vaccine production: learn more about vaccine process development and application expertise.