Quality/GMPs

Biotech companies are among the most intensive instrumentation users of any FDA-regulated business. Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.

When developing a strategy for using technology in biopharmaceutical manufacturing, include the interaction between automation and business systems and the roles they play in enhancing quality assurance and compliance.

Process characterization requires a significant commitment of time and resources, but the payoff is better process understanding, improved manufacturing success rates, and avoidance of costly regulatory delays.

Good laboratory practice is the central dogma of all laboratory research and investigation - it's your commitment to regulators - and poor laboratory controls are a common cause of 483 observations and preapproval inspection failures.

BioPharm International and Tefen Ltd. have teamed up to provide you with information and tools from the BioPharma Operations Excellence Consortium.

Supplementing your existing staff with experienced contractors when your process is ready for validation can help you avoid common validation mishaps - if you know the ingredients of successful project management.

In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.

A successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.

FDA efforts to encourage generic drug approvals and to consolidate oversight for biotech therapies could open the door to biotech equivalents