July 4th 2025
Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.
Why GMPs? What are GMPs and Why Do We Need Them?
November 15th 2004Good manufacturing practices (GMPs) are manufacturing guidelines for ensuring the safety and efficacy of drug products and medical devices. The GMPs are legal regulations, based on the United States Food, Drug and Cosmetic Act. But, why do we need the GMPs? Shouldn't we, as knowledgeable individuals, groups, and companies, be able to figure out how to produce drugs and devices that are safe and effective?
Beyond GMPs: The Latest Approaches to Good Manufacturing Practices
November 15th 2004GMP is the acronym for Good Manufacturing Practice. The GMPs represent a set of regulations that were promulgated as a final rule by FDA in 1978 and intended to ensure the safety and efficacy of the nation's drug products. The GMPs, as we know them today, are the result of over a century of actions by industry and reactions by government and consumer groups to bring guidance and controls to the food and drug industry, resulting in a safe supply of food and medicines.
Mindful Compliance: Where Knowledge and Regulations Meet
November 15th 2004There continues to be much interest within industry and FDA about the future of the GMPs. Discussion groups have been spawned within professional organizations and at FDA to reevaluate the aging GMPs and associated guidance documents to ensure that the government does not impede technological progress, focuses its resources effectively, and upholds its mandate to protect the public.
Editorial—Educating The Masses About Biopharma
November 1st 2004Idon't know about you, but I found Senator John Kerry's assertion that President Bush was to blame for the US flu vaccine shortage quite laughable, but only until it became clear Kerry intended to continue railing about it throughout his final campaign thrust. As political tactics would have it, of course there was no mention of the Comprehensive Child Immunization Act of 1993, back-door price controls, and the resultant US dependence on external vaccine suppliers.
Supply Chain Cycle Time Reduction
October 1st 2004Wyeth BioPharma has identified cycle-time reduction as critical to customer responsiveness and the success of commercial and pipeline products. In formulating a plan of attack, the company focused on two aspects of cycle time: the global planning process and disposition cycle times.
Editorial—Public Pressure, the Press, Politics, and Profits
September 1st 2004American patients are more educated about health issues than any prior generation, thanks to the Internet. I read somewhere that doctors, from family physicians to specialists, are amazed at how well prepared their patients are when they show up for an appointment — with documentation in tow after researching conditions, medications, and treatments. So much so that the doctors are stressed out from trying to answer all their questions, complete their exams, and get everyone out the door in the amount of time the insurance companies say is "reasonable."
Operations Excellence: The Art of Improvement
September 1st 2004The concept is not new. Companies comparing performance and practices and then mutually identifying the best solutions to common operational challenges has been a part of business for years. What is different is that this is happening in the biopharmaceutical industry, which, until recently, has been primarily focused on filling the pipeline and on improving the manufacturing processes themselves. This focus was not misguided- the biggest challenge facing biopharmaceutical companies until the last five years was convincing everyone that they were legitimate players that can develop and supply therapeutics consistently, and not isolated success stories.
Optimization, scale-up, and validation ISSUES in FILTRATION of Biopharmaceuticals, Part II
September 1st 2004Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step.