Vaccine Analysis

Specialised analytical characterization and quality control services for vaccine drug substances and drug products.

Vaccines represent some of the most complex biological products in the pharmaceutical portfolio, comprising multiple biological components—including antigens, adjuvants, excipients, and process-related impurities—that must be characterised, controlled, and monitored throughout manufacturing.

For Quality Control Managers overseeing vaccine quality control, the complexity of the analytical programme and the critical importance of potency and safety testing require an analytical services partner with extensive expertise in vaccine characterization and a thorough understanding of the regulatory frameworks established by the WHO, EMA, and FDA.

AMSbiopharma provides specialised analytical services for the characterization and quality control of non-live, recombinant, and combination vaccine products, supporting CMC development.

Our catalog of services include

Vaccine Analysis (Ingredient Characterization, Non-Live and Recombinant Vaccines)

Analytical characterization of vaccines encompasses testing to evaluate antigen identity, purity, and content, adjuvant characterization, excipient analysis, process-related impurity profiling, and container closure system integrity. For recombinant vaccine antigens, structural characterization by mass spectrometry, glycosylation analysis, and higher-order structure (HOS) assessment provide critical quality attribute data.

AMSbiopharma provides validated analytical services for vaccine component characterization and quality control, applying validated methods aligned with WHO, EMA, and FDA guidelines, as well as applicable pharmacopoeial requirements.

Key analytical capabilities

  • Antigen identity confirmation and structural characterization by mass spectrometry 
  • Antigen content determination using validated quantitative methods 
  • Adjuvant characterization and quantification 
  • Process-related impurity profiling 
  • Support for CMC development and regulatory submissions to the WHO, EMA, and FDA