Quality/GMPs

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.

Wyeth 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.

The "due diligence framework" is an efficient process. But efficient is not the same as quick and easy. There are no shortcuts. The framework minimizes resource commitments and disruptions to ongoing programs and helps each side learn what it needs to know. In six steps, it converts the typical due diligence root canal into a painless filling.

American 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."

A 20% TSP-producing cultivar can generate up to 265 pounds of crude recombinant protein per acre.

To help speed promising new treatments to market, FDA is streamlining its oversight of oncology therapies, including biotech products.

As with any partnership, working with a CMO can be complex. The level of trust and cooperation between both organizations needs to be extremely high.

If the system is not 21 CFR Part 11-capable or the network configuration is not appropriate, cost is immaterial.

The objective of the feasibility stage is to determine whether the proposed biotechnological process can be executed.

The 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.

Filtration 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.