Vaccine Development

Scientific research has led to the development of numerous types of vaccines that safely elicit immune responses that protect against infection, and researchers continue to investigate novel vaccine strategies. Vaccines are designed to teach the immune system how to fight off viral infections, bacterial infections, cancer or metabolic diseases.

There are several platform technologies used to develop and manufacture vaccines. Included in these platform technologies are: Whole-pathogen vaccines (Live-attenuated and Inactivated vaccines), Nucleic Acid Vaccines (plasmid DNA and mRNA vaccines), Viral Vector (virus-like particle or VLP vaccines), and Subunit Peptide or Protein Antigen Based Vaccines.

Regulatory guidelines require testing for cell substrate related impurities, media and purification additives as well as adventitious agents throughout vaccine development to study the candidate vaccine's purity, safety, and efficacy [1,2].

Cygnus Technologies has been proactive in developing a menu of HCP ELISAs and impurity assays for all common vaccine production systems.

[1] Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications; Guidance for Industry, Feb 2010 

[2] Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product; Guidance for Industry, January 1999