Lot release testing
Release testing is a key step of biologics manufacturing which aims at testing middle or- end-of-process biopharmaceutical material to ensure that it is safe, potent, and meet expected quality attributes.
Tests of release should comply with both industry standards and government-issued regulatory guidelines for each type of biological medicinal product. Additionally, batch release testing needs to occur under the cGMP quality framework with assays qualified and validated for the intended purpose and clinical phase. This testing encompasses a combination of analytical, physical, chemical, and biological methods which should take into account batch-to-batch consistency.
With its cGMP certification and 20+ years in quality control, Clean Cells has become a leader in biologics evaluation and lot release testing through an extensive portfolio of validated and cGMP-ready assays.
Biosafety testing and characterization assays
When talking about release testing one should differentiate between starting material, intermediate of production such as bulk harvest, and drug substance or drug product. In any case, biological material undergoes release testing to evaluate the quality, safety and consistency the manufacturing. But depending of the type of type of material or the step in the process, assays and corresponding specifications will be as diverse as:
- Sterility and mycoplasma testing
- Endotoxin quantification
- Virus biosafety testing: confirms freedom from adventitious agents during lot release testing by cell culture assays, qPCR assays (species-specific) and in-vivo testing.
- Retrovirus
- Electron microscopy
- Impurity testing
- Titration (for virus-based therapies)
- Functional and potency testing: depending on the manufactured material, additional functional tests (eg. cell-based assays) can be required as part of batch release.
Risk-assessment determine the extent of biologics testing . Assays should be specifically validated with the material being testing in accordance with the intended clinical or commercial phase.
Our Quality Management System has been extensively audited by numerous governmental bodies and industry partners to ensure the integrity of records during release testing procedures.
For more information, please do not hesitate to contact us.
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