J Geigert — Page 2 | PubMed Health

PubMedDate not supplied

Role of quality control in validation of biopharmaceutical processes: case example of clean-in-place (CIP) procedure for a bioreactor.

If ever clear instruction and close teamwork is needed, it is in the validation of manufacturing processes. All members of the Validation Team need to understand how the Quality Control testing fits into the overall validation work plan. This affords the team members the opportunity to understand how data will be used and avoids a situation where the test results either invalidate or inadequately support the validation plan. A case example is presented for an approach used to validate Clean-in-Place (CIP) procedures for 1600 L bioreactors which are operated on a campaign basis for multi-biopharmaceutical synthesis.

Chromatography, High Pressure Liquid↗

PubMedDate not supplied

Appropriate specifications at the IND stage.

Biopharmaceutical product specifications are to be "scientifically sound and appropriate." However, how does a biopharmaceutical company determine acceptable specifications for its product at the early stages of clinical development? Are there really enough test data at the start of the IND trials to "establish" specifications? As an industry, are we doing too many tests at the IND stage (i.e., the "must do every test on someone's published list" syndrome), and then finding that specifications need to be set for each test we run? Are we feeling pressured (either by regulatory agencies or by our own corporate cultures) to set unrealistic and light specifications at the IND stage, and then later regretting having to justify loosening them when we gain more experience with the release testing or stability of our products? A discussion on how to set practical product specifications for biopharmaceutical products at the IND stage is presented.

Chromatography, High Pressure Liquid↗