Quality/GMPs

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.

Continuous Improvement requires a sound philosophy. Is your company following the correct principles?

The industry entered 2004 with a strong balance sheet - about $16 billion in cash and a wide-open pipeline full of new drugs and products.

Disposable systems only require initial cleaning validation, and ongoing validation activities are typically limited to operator training and routine monitoring.

What were you doing on the evening of July 20, 1969? If you are at least a baby boomer, you were probably watching Neil Armstrong take "one small step for man, one giant leap for mankind." Sputnik aside, the birth of that monumental achievement probably began with the same question that sparked so many other great feats: "What if?" Where would civilization be if someone periodically hadn't had the imagination and the courage to ask that question, whether their field of expertise was aeronautical engineering, architecture, or biotechnology?

One main component of an e-prescribing system is access to accurate, up-to-date information on prescription drugs and biologics based on FDA-approved labeling.

A water distribution plan is at the heart of an overall energy and water conservation program.

Like any other financial venture, investing in PMPs requires both the patience of a saint and the ability to absorb some bad news and still hang in there.

Filtration is one of the most commonly used unit operations in biopharmaceutical manufacturing. Available formats include direct or normal flow filtration (NFF) and cross or tangential flow filtration (TFF). These methods are used for sterilization and virus filtration, depth filtration or ultrafiltration, and diafiltration applications. Some common objectives include:

Synthetic ligand adsorbents can eliminate the potential hazards of animal- and microorganism-sourced ligands, minimizing running, cleaning, and validation costs.

There is no current capacity crunch due to increased investments in new facilities.

Although sounding like a singular term, a water purification system actually consists of several key components.

Green plants and production systems that are most removed from conventional commercial food and feed crops are most likely to succeed

This technology includes an efficient and scalable in vitro enzymatic amidation step for peptide hormones.

The debate over drug importation is a prime example of politics trumping science as members of Congress reject the consensus of scientists and policy experts that opening US borders to therapies from abroad raises serious public health concerns.

Although there are many differences between the industries, especially related to regulatory requirements, there are enough similarities that the future of biopharmaceuticals with respect to contract manufacturing might look much like the semiconductor industry.

Is it safe? Answering that question for therapies based on living cells is not simple.

The employer's first step in considering whether to use non-competition and non-disclosure agreements is to assess, analyze, and understand the benefits of such agreements.

According to a 2002 report by the consulting firm BioPerspectives, the protein biochip market will reach $700 million in sales by 2006.

Very significant progress has been made since the mid-1970s when dye ligands were first introduced.

The approaches taken to containing the risk of BSE reveal patterns in the difficulties of performing and reacting appropriately to risk analysis.