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Merck

Bulk Harvest Release Testing for Vaccines

Biosafety testing for vaccine development

All biologics, including vaccines, must undergo biosafety testing to meet regulatory requirements. Our long history of supporting the development, manufacture, and commercialization of safe biological drugs and vaccines makes us the partner of choice for companies looking to accelerate vaccines to market by utilizing efficient and robust biosafety testing approaches.

We offer cGMP-compliant bulk harvest release testing support for a variety of vaccine types, including:

  • Inactivated / Live-attenuated vaccines
  • Vector based vaccines
  • Nucleic acid vaccines
Illustration of vaccine created by live attenuation

Inactivated / Live-attenuated vaccine

Illustration of vector-based vaccine

Vector-based vaccine

Illustration of nucleic acid-based vaccine

Nucleic acid vaccine

We take an innovative approach to the development of new, rapid methods for biosafety testing. Many of our GMP compliant assays can be conducted under biosafety level 3 containment, enabling testing for live virus samples (such as those relevant to the production of inactivated viral vaccines and challenge agents) and the execution of viral infectivity assays.

In addition, as part of our extensive range or product characterization services, our potency assays are customized, using platform methods where possible to speed development, based on the expected mode of action of the product.


Related Product Resources


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Rapid Biosafety Testing Services Supporting Vaccine Development

* We offer a “Complete Clearance” service, where our highly experienced process scientists will perform all process steps, allowing manufacturers to maximize their own resources.


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