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Vaccines
We offer a comprehensive suite of services to help characterize the safety, efficacy, and purity of your vaccine to meet your unique development needs.
Pre-Vaccine Testing Services
Immunogenicity of vaccine antigens along with other characteristics is critical in determining the suitability of the vaccine and ability to meet regulatory requirements. We work closely with your team to test your vaccine and get all the derivable information in its early development.
Preclinical Vaccine Testing Services
Post-Manufacturing Vaccine Testing Services
The fields of vaccine development, characterization, testing and validation are especially complex because of the range of applications — as preventive vaccines, immunizing agents and therapeutic vaccines and the range of sources — DNA, recombinant proteins, bacteria and viruses.
DNA vaccines have benefited from the rapid pace of genomics research. Indeed, the combination of genomics and DNA vaccines holds out the promise of revolutionizing the practice of human immunization. As well as the numerous advantages these products offer, they also require extensive testing. For example, because there is potential for the injected DNA to randomly integrate into the genome, biodistribution studies (see gene therapy products for a discussion) are of paramount important with DNA vaccines.
Recombinant protein vaccines have great potential against HIV and other infectious agents, but they also demand extensive testing. It is critical to test the raw materials and cell banks used in the production of recombinant protein vaccines for contamination, as well as to monitor the bulk harvest of the product. Finally, assessment of stability and safe, reliable storage are of paramount importance in ensuring the security of the product throughout its development and commercial production.
Bacterial vaccines, whether whole cell or subunit vaccines, present their own challenges for characterization and testing. For whole cell bacterial vaccines in particular, purity analysis is quite challenging. At Covance, we have expertise in numerous methods for these analyses, including a wide range of HPLC techniques and mass spectrometry (MALDI-ToF). Subunit vaccines also require extensive protein characterization, as described in protein characterization, stability analysis and batch release testing.
Viral vaccines have benefited from advances in recombinant DNA technology, and their safety is enhanced by advances in testing for adventitious viruses and retroviruses. Using state-of-the-art techniques, Covance Biotechnology Services provide the expertise you need to assure the safety of your viral vaccine products. For more information, refer to the section on gene therapy products.
Learn more about these key services:
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