NDA Analytics has performed cGMP compliant QC lot release and stability testing of a wide variety of vaccines including synthetic peptides, recombinant proteins, attenuated bacterial and viral pathogens, and DNA vaccines, from a range of therapeutic areas such as infectious disease, oncology and allergy.

Our service offering falls into three key areas:

- Physicochemical assays to determine the appearance, identity, quantity, purity and impurities of the vaccine, including product specific assays for unique dosage forms such as needleless injectors

- Microbiological assays to determine the microbial contaminaton of the drug and in case of live vaccines the titre of the product

- In vivo and in vitro cell based bioassays to determine the potency of the vaccine

Measurement of biological potency, more commonly described as immunogenicity, is crucial for vaccines. For most vaccines this requires in vivo testing, often called 'dose and bleed' assays. 

To ensure your product moves through the compliance pathway smoothly these assays require increasingly stringent validation criteria the closer the product gets to market. Vaccine immunogenicity assays are required to demonstrate pharmacologically relevant endpoints, they are thus product-specific and require extensive scientific understanding of the nature of vaccination in order to design the appropriate strategy.

There are two main approaches to potency testing of vaccines and assays may be performed on serum, plasma, whole blood, splenocytes or lymph nodes:

- Humoral immune response - where the antibody response against a vaccine is measured. The isotype of the antibody response may also be determined to better understand the immune response bias

- Cellular immune response - where typically ex vivo recall assays are utilised to measure cell based immune responses

There are a number of applications where in vitro or ex vivo approaches have also been used to assess potency of vaccines. Some of these are included in pharmacopoeias, however their acceptance as an alternative to in vivo studies varies between territories.

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