Friday, November 1, 2013 Daily Archives

Effects of Pressure Sensor Calibration Offset on Filter Integrity Test Values

Food and Drug Administration (FDA) and European good manufacturing practices (GMPs) require integrity testing of sterilizing-grade filters for producing injectables and other biologics. The diffusion test (also called the forward-flow test) and bubble-point test (also called the disk test) of a sterilizing-grade filter are both filter-integrity tests. The accuracy of both relies on calibration of a pressure sensor in the respective integrity test unit. Calibration of the pressure sensor of a filter-integrity testing device is an essential part of quality…

Enhancing Antibody Production

Increasing demand for monoclonal antibodies (MAbs) — useful as immunodiagnostic reagents in basic research applications and potential immunotherapeutics — has created a need to optimize protein production techniques. Many developers have attempted to increase MAb output from cell culture by addressing both equipment and consumables. For example, recent advances in improved bioreactor designs and bioreactor operation have increased antibody outputs by increasing cell densities and extending cell life in culture. Materials and Methods () Bioreactors can operate in batch, perfusion,…

Government Medicaid Reporting

On 27 January 2012, the US Centers for Medicare and Medicaid Services (CMS) published a much-anticipated proposed average manufacturer price (AMP) rule for implementing related prescription drug provisions of the Patient Protection and Affordable Care Act (PPACA). The new rule will create serious financial, administrative, and operational challenges for the life-sciences industry. Nearly two years later, the final rule has not been issued. Without official direction, we can look back at the proposed rule’s purpose and recommendations for manufacturers based…

Six Essential Workflow Steps for Paperless, Automated, End-to-End Environmental Monitoring

The consequences of microbiological contamination range from FDA warning letters through product quarantines and recalls all the way to plant shutdowns. This makes quality control, specifically microbiological and environmental monitoring (EM) a mission-critical priority for pharmaceutical and biotechnology drug manufacturing operations.
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