Biologics Testing or biologically active therapeutics can be manufactured using a wide range of innovative platforms including Microbes, Mammalian Cells, Stem Cell Therapies, Gene Therapies and Transgenic Animals. Regardless of the manufacturing platform there is a primary requirement to ensure the safety of the drug throughout the development and commercial release of a licensed product.
Our team of scientists at BioOutsource have unparalleled technical knowledge and regulatory expertise in the design and execution of Biosafety Testing Programmes. Our suite of services include all of the guideline specified tests as well as innovative systems to test a variety of novel cell platforms.
A Master Cell Bank is created at the start of a project to manufacture a Biologic. As this is a crucial starting material the regulations require that the following three key testing requirements are fulfilled:
- Identity which requires that the species of cell and the gene construct used to generate the product are verified.
- Purity which requires freedom from contamination is demonstrated.
- Stability which requires that the cells are able to yield product in a consistent manner.
A Working Cell Bank may often be created from the Master Cell Bank at the start of a project for Biologics and as with the Master Cell Bank, testing for Identity, Purity and Stability are required.
An End of Production Cell Bank is created from cells which have been expanded in a similar manner to the production cells. These cells are used to test the stability of the cells during normal processing; this is accomplished by a variety of molecular techniques used to show stability of the gene insert. Purity is also a concern for the End of Production Cell Bank to establish the bank is free from both adventitious and endogenous micro-organisms.
Bulk Harvest Testing is the generic term for the harvest of a cell fermenter before any downstream purification has occurred. This in process sample is required by the guidelines to be tested to demonstrate freedom from adventitious contamination.
Final Product Characterisation: 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.