Title 22. STANDARDISATION OF VACCINES AND SERA.pdf ✅

PHARMD GURU Page 1 STANDARDISATION OF VACCINES AND SERA:  Standardization can also be called as quality control of vaccines and sera.  Comparison of test sample assay with the standard is also called as standardization.  Vaccines provide an antigenic stimulus that does not cause disease but can produce long lasting, protective immunity sera containing antibodies. Standardization of vaccines and sera is a critical process to ensure their safety, efficacy, and consistency in protecting against infectious diseases and providing passive immunity. Here's an overview of the standardization process for vaccines and sera: TOXICITY TEST: Preventative and therapeutic vaccines are increasingly used during pregnancy - special considerations are necessary for development of toxicity testing. STERILITY TEST:  It can be defined as the freedom from the presence of viable microorganisms.  Most biological products, including vaccines, administered by the parenteral route are required to be tested for sterility at the final container and also at various stages during manufacture.  The sterility testing as per Code of Federal Regulations and the United States Pharmacopoeia is based on the observation of turbidity in liquid culture media due to growth of potential contaminants. POTENCY TEST:  Combination vaccines differ from single-component vaccines in composition and manufacturing method and also poses significant challenges in implementing effective quality-control tests, including measurement of potency.  Because each combination vaccine is unique, existing guidelines often fail to provide sufficient information to overcome the inevitable problems encountered when developing and implementing potency tests. STANDARDISATION OF VACCINES AND SERA
PHARMD GURU Page 2  The BCG albumin assay is designed to measure albumin directly without any pretreatment of samples, such as serum, plasma, urine, and biological preparations.  It may also be used to measure effects of drugs and other compounds on albumin metabolism. It can be used for corvette or multiwall plate assays.  The multiwall plate assay uses samples as small as 5 mL and can be readily automated as a high-throughput assay for thousands of samples per day.  The procedure involves addition of a single working reagent and 5 minute incubation. The intensity of the color, measured at 620 nm, is directly proportional to the albumin concentration in the sample. SAFETY TEST:  The abnormal toxicity test (ATT) using mice and guinea pigs is a non-specific safety test for vaccines, sera and immunoglobulins.  Positive ATT's never resulted from the insufficient quality of a batch.  On the other hand, vaccines causing adverse reactions In the target species were not identified by the ATT. ENDOTOXINS TEST:  Twenty samples of commercial vaccines intended for administration to humans were assayed for the presence of bacterial endotoxins by using the Limulus amebocyte lysate test.  Sixteen of the vaccines contained more than 0.1 mg of endotoxins per ml.  These results suggest that at some stage of preparation, the vaccines have contained varying amounts of gram-negative bacteria and may indicate the presence of other bacterial products as well.
PHARMD GURU Page 3 ADDITIONAL INFORMATION: STANDARDISATION OF VACCINES AND SERA: Standardization of vaccines and sera is a critical process to ensure their safety, efficacy, and consistency in protecting against infectious diseases and providing passive immunity. Here's an overview of the standardization process for vaccines and sera: ANTIGENIC CONTENT: One aspect of standardization involves determining the antigenic content of vaccines and sera. This includes quantifying the concentration of specific antigens or antibodies that elicit an immune response against the target pathogen. Methods such as enzyme-linked immunosorbent assay (ELISA) or quantitative polymerase chain reaction (qPCR) may be used for antigen quantification. POTENCY ASSAYS: Potency assays are conducted to measure the biological activity or effectiveness of vaccines and sera. These assays assess the ability of the product to induce an immune response or provide protection against the target pathogen. For vaccines, potency assays may involve in vivo studies in animal models or in vitro assays using cell cultures. Serum potency assays may measure the ability of sera to neutralize toxins or inhibit microbial growth. STABILITY TESTING: Standardization also includes assessing the stability of vaccines and sera under various storage conditions, including temperature, humidity, and light exposure. Stability testing helps determine the shelf life of the products and ensures that their potency and efficacy are maintained throughout their intended storage period. ADJUVANT CONTENT: Many vaccines contain adjuvants, which enhance the immune response to the antigen. Standardization may involve quantifying the concentration of adjuvants and ensuring consistency in their formulation. Adjuvant content is critical for vaccine potency and safety.
PHARMD GURU Page 4 SAFETY TESTING: Standardization includes rigorous safety testing to evaluate the potential adverse effects of vaccines and sera. This includes testing for contaminants, such as microbial pathogens, toxins, or residual chemicals, as well as assessing potential allergic reactions or other adverse events associated with the products. REGULATORY COMPLIANCE: Standardization of vaccines and sera must comply with regulatory requirements established by national regulatory agencies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Regulatory authorities set standards for vaccine manufacturing, testing, labeling, and distribution to ensure product quality, safety, and efficacy. Overall, standardization of vaccines and sera is essential to ensure their quality, safety, and effectiveness in preventing infectious diseases and providing immune protection to individuals and populations. It involves a combination of scientific testing, regulatory oversight, and adherence to established standards and guidelines.