Quality/GMPs

Manufacturing changes - such as changes in formulation or source material - can impact a product’s immunogenicity.

In order to institute a GxP mindset across the organization, support and respect for quality systems should come from the top down.

You don't need me to tell you how bad the news has been for the pharmaceutical industry in the last two months. First, it was antidepressants for children, then Vioxx. It took maybe 48 hours before the first tort request hit the airwaves, asking to hear from those who'd experienced heart attacks or strokes after taking the drug. Celebrex came next, followed by NIH announcing it put the kibosh on a study of naproxen.

In the increasingly competitive world of drug discovery and development, the role of branding is more important than ever. With all the various sectors - big pharma, generics, specialty pharma, and biotechnology -vying for limited dollars, branding must begin early in the development process and, ultimately, play an integral role not only in taking a product to market, but also in sustaining that product against competition, perceived and real.

Transgenic plant systems promise lower production costs since plants can be grown in a field instead of a cell-culture facility. Also, they provide an alternative production system for proteins that are difficult to express in cell culture.

The re-election of George W. Bush as president and continued Republican control of Congress will shape the healthcare policy agenda for the coming year. Major initiatives to expand healthcare coverage to the uninsured or reform Medicaid are off the administration's priority list, but social security and tax reform may provide additional tax incentives for individuals and small businesses to obtain health coverage and establish health savings accounts.

For years, the pharmaceutical sector has provided a safe haven for investors. I'm not so sure that will be the case in 2005.

Biopharmaceutical companies are developing clever technologies for plant made pharmaceuticals (PMPs). When will the promise for the future turn into reality?

The last few months of 2004 were marked by crises likely to affect pharmaceutical and biotech manufacturing for years to come. Safety data indicated that antidepressants may cause problems for young patients that warrant black box warnings, new labeling, and special packaging. Merck pulled its blockbuster COX-2 inhibitor Vioxx off the market because studies showed increased risk of cardiac events from long-term use of the drug. To cap it off, British regulators shut down Chiron's Liverpool vaccine plant due to product contamination, creating a serious shortage of flu vaccine in the US.

Immune responses to foreign proteins are expected and may be anticipated for some self-proteins. The rapidity of development and the strength and persistence of the response depends on many factors.

Project management is a specific set of skills and processes administered to meet the specific complexities of a project.

The holidays are upon us. It's the time of year that begins with gala parties in December and ends when you finally realize what you spent, usually around April 15 of the next year. Too Scrooge-like? Hope not. I just partook of some bad eggnog.

What are current good manufacturing practices (cGMPs)? Where did they come from? What are the actual "practices" described in the Code of Federal Regulations, 21 CFR. If you are new to the pharmaceutical or biotechnology industries, you may enter your first "GMP Training" session without much context or perspective. A set of arcane rules is presented; you were never taught these in science classes.

Good 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?

GMP 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.

There 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.

Idon'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.

The mine space is greater than the volume of all homes for a city of one million people. The second facility has been mapped at 22,500 acres.

When replacing an existing method, it may be necessary to compensate for a significant difference between the current and new method by adjusting the specifications.

Over the last five years, alternative investments have been the fastest growing investment strategy in institutional investment markets.

Neutralization of therapeutic protein products does not produce an obvious clinical deficiency syndrome for all therapeutic protein products with endogenous counterparts, because many endogenous proteins are biologically redundant.

Even if FDA does not require pharma companies to co-market a diagnostic test, insurers and health plans

We've gone beyond the days when corporate America's idea of a healthy outing was a company softball game complete with beer and hot dogs.

Recognize that the drug drought is the "disease" underlying many of pharma's troubling symptoms, and the cure becomes apparent.

Establishing bioequivalence is difficult for drugs with high inter-subject variability or strong dependence on the physiological state of the gut.

Big Pharma execs bring to biotech the knowledge of what it takes to make something a commercial success-not getting to market, but to Phase I.

Even if FDA does not require pharma companies to co-market a diagnostic test, insurers and health plans may pressure industry to do so, according to Robert Temple of CDER.

EVERYONE KNOWS THAT ROCHE WAS, AND ARGUABLY STILL is, the driver of Genentech's success. But not everyone knows that Roche owns a majority stake in the biotech behemoth, as it does in Japanese powerhouse Chugai. And that's by design. Roche's management has long held that the best way to derive good and lasting results from its smaller partners is to let them do what they do best and leave them alone while they do it. That philosophy has served them well, especially when revenues of some of their codeveloped and comarketed blockbuster products are considered. Just two, Genentech's Herceptin (trastuzumab) and Chugai's Epogin (epoetin beta), have earned billions.

He potential for frustration, time-wasting, and bad feelings between pharma and biotech partners is enormous. That some successful decisions are made under these circumstances is something of a miracle.

The relationship between "valid" or "suitable and validated" is often overlooked, but there is a high price when "validated" test systems are simply inappropriate.