Vaccine Testing - Final Product
Final Product Characterization: Drug Substance is the term used to describe the bulk drug after all of the downstream purification has occurred. This substance usually has excipients added such as buffers or other materials. The Drug Substance requires characterisation to demonstrate the drug has been manufactured to meet specifications. Testing is required to establish the molecular characterisation of the drug using methods such as HPLC or Gel Electrophoresis. In addition the drug must be tested using a Potency Assay to establish efficacy.
Drug Product is the term to describe the final vialed drug material which can be administered to patients. This material must be tested using a variety of methods as outlined in the Drug Master File which confirms the Drug Product specifications. These tests will include measures of potency plus other characterisation tests and assays to ensure both sterility and safety.
|Determination of the level of Bacterial Endotoxins||The test for Bacterial Endotoxins (BET) is used to detect or quantify endotoxins from gram-negative bacteria using the chromogenic technique, based on the development of colour after cleavage of a synthetic peptide-chromogen complex.|
|Extractable Volume||The assay is required to show that the required dose or volume for injection can be removed from the final drug container.|
|Determination of sample pH||The purpose of this assay is to determine the pH measurement of the sample|
|Determination of water composition||This method is performed to determine the water composition of the sample.|
|Osmolality||The purpose of this assay is to determine the osmolality measurement of a sample.|
|Product Potency - In vivo or in vitro assay||These assays are required to show the material is active and to provide a measure of the specific activity of the product.|