Quality/GMPs

As the bustle of Sarbanes-Oxley (SOX) 2004 compliance deadlines for companies winds down, executives have an opportunity to reconsider their company's compliance strategy.

Last year's catastrophic flu vaccine shortage and escalating Congressional debate over drug safety continue to shine the spotlight on biotech product manufacturing. FDA officials are under pressure to address concerns about access to quality biotech products, while also encouraging the development of new treatments to meet patient needs.

An anionic column with modified chitosan bead matrix performs well in purifying cell culture. A pair of cationic-exchange columns shows promise in purifying S25 antibody.

Utilizing a measured approach can increase the probability for identifying search criteria that fulfill a company’s strategy.

Cancer remains the primary indication (three products), again mirroring recent approval trends.

Saturated fractional factorial plans minimize the number of trials by one-half or better, which saves time and money.

Despite the ringing of two stray cell phones disrupting the quiet, all eyes and ears were glued, almost reverently, on New York City's former Mayor Rudy Guiliani at INTERPHEX when he presented the day's keynote address. First, he thanked the audience for providing the therapeutic options that allowed him to successfully defeat prostate cancer awhile back. Next came his imitation of James Gandolfini in the hit TV show "The Sopranos," as he reminisced about his duties as NYC's former chief prosecutor. Once he had our full attention, close to 1,000 of us, he shared what he felt are the most valuable leadership attributes and how they will successfully get you through challenging and uncertain times.

Three meetings of the BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, were held recently. The east coast meeting was hosted by Genzyme at its headquarters in Cambridge, MA; the west coast Chapter met at the Genentech campus in South San Francisco, CA; and the European forum held its meeting in Frankfurt, hosted by Aventis.

$200 million and two years could be shaved off a drug's development time by using informatics effectively.

Geron rose 7% and StemCells 15% . . . when news of the New York capital funding effort hit the business pages.

FDA will allow nonprescription NSAIDs to share the market with products carrying black-box warnings.

You don't really care what people say about you (the biopharm industry) behind your back, do you? According to a recent survey of 670 BioPharm International subscribers, conducted by Derek Ellison from Eden BioDesign, some of you care very much about the public's perception of the industry.

During the past several years in the pharmaceutical and biopharmaceutical industries, conflicts and misunderstandings have arisen between companies and their contractors. Too often, productive working relationships have crumbled, resulting in expensive production delays with companies and contractors squabbling over their roles and responsibilities. Such conflicts may have their roots in the lack of a sound quality agreement (QAG). QAGs that clearly delineate good manufacturing practice (GMP) responsibilities between a sponsor and a contractor can help companies and their contractors avoid certain conflicts.

Mass serialization, or the ability to store a unique serial number for each item, is the most useful feature of RFID tags.

Even if some clinical testing is needed, generics makers argue that no one-size-fits-all testing approach is appropriate for the broad range of biopharmaceutical complexities.

Biotechnology and life sciences companies come in all shapes and sizes. Some are multinational companies with vast resources and others are small companies working with a few new compounds. Regardless of size or market position, these companies should all have one common question of those that handle their insurance: Will their current insurance program protect their assets and investments in the event of a significant loss? Understanding the nature of risks, acquiring suitable insurance, and comprehending policy issues when claims arise are essential to protecting assets and obtaining reimbursement when losses occur.

With biotech valuations at the lowest point in years, the resulting investment opportunities are multiplying - seemingly by the hour.

Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes - chromatography and filtration.

When you don't know the answer to a question, ask an expert. If the question is really big, ask more experts. If you have a collection of difficult questions, run a poll of many experts. That, in effect, was the impetus for Eden Biodesign to survey 670 BioPharm International subscribers with questions as to what will be the development mechanism to achieve safe, effective, and cheap new medicines.

Out-licensing has become a crucial part of most biotech companies' business strategies.

This was the week for awards. The Academy Awards, which honored the film industry, captured the eye of millions worldwide. They were followed midweek by The Fourth Annual Top 25 Direct-to-Consumer (DTC) Marketers of the Year Awards. Sponsored by USA TODAY and DTC Perspectives magazine, these awards celebrated the accomplishments of 2004's most talented DTC pharmaceutical marketers.

Analytical method validation (AMV) is required in the biopharmaceutical industry for all methods used to test final containers (release and stability testing), raw materials, in-process materials, and excipients. 1 AMV is also required for test methods that are used to validate the process prior to process validation. This article reviews current regulatory guidelines and the critical elements of analytical method development (AMD) that should be finalized before starting AMV.

Synthetic drugs can be well characterized by established analytical methods. Biologics on the other hand are complex, high-molecular-weight products, and analytical methods have limited abilities to completely characterize them and their impurity profiles. Regulation of biologics includes not only final product characterization but also characterization and controls on raw materials and the manufacturing process.

The BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, continues to thrive, recently holding chapter meetings on two separate continents. The US East Coast Chapter met at Centocor's headquarters in Malvern, PA, while the European Chapter met at Sorono's facility in Vevey, Switzerland. Since its establishment in early 2002, over 45 leading biopharmaceutical companies have joined the forum, which operates on the basis of using the group's collective knowledge to drive each member company - and the industry as a whole - to world-class levels of operational effectiveness and efficiency.

Many types of equipment in both manufacturing and laboratory areas are critical to a properly functioning pharmaceutical process. The validation of laboratory equipment is not as clearly defined as the validation of equipment used directly in the production of pharmaceutical products, which requires thorough validation in almost all situations.

Bioterrorism legislation is in the works, but there will be a tough fight to enact added liability protections for manufacturers.

RARM procedures don't exist in a vacuum. For people to perform effective and useful RARMs, the process needs to be integrated with other GMP quality system elements and be proceduralized.

Pharmaceutical companies today are faced with increased costs for drug discovery and development and aggressive competition from generic drug companies. As research costs skyrocket, generic drug companies sit poised and ready to compete as soon as a patent expires.

There are challenges aplenty in purification and analysis of PEGylated protein pharmaceuticals. Here are a variety of technical solutions, many concentrating on the chemistry of the linker.

The variety of microbiological tests makes it difficult, if not impossible, to prescribe a single, comprehensive method for validating all types of tests. By their very nature, microbiological tests possess properties that make them different from chemical tests. Consequently, the well-known procedures for validating chemical tests are not appropriate for many microbiological tests. Yet, it is necessary to validate microbiological tests if they are to be useful for controlling the quality of drug products and devices. Test-method validation provides assurance that a method is suitable for its intended use. Given this definition, any rational company would want to be sure that its methods are validated.