Development

EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials.

Grass allergic patients in Germany are the first to benefit from new vaccine

Research Triangle Park, NC (Nov. 13)-Eisai Inc. broke ground here for a new pharmaceutical production and formulation research and development facility for parenteral oncology drugs.

AAPS, San Antonio (Oct. 31)-Excipient manufacturers are raising concerns over recently adopted European guidelines, set to become effective January 1, 2007, which provide a framework and approach for dealing with genotoxic impurities in new active substances.

Philadelphia (Oct.24)?Failures to review batch failures and unexplained discrepancies are the leading cause of Food and Drug Administration Form 483 observations and Warning Letter citations issued to pharmaceutical companies.

Mid-size regional players have little chance for success in an industry increasingly dominated by large global players.

AstraZeneca's purchase of Cambridge Antibody Technology and Merck's acquisitions of GlycoFi and Abmaxis are the latest efforts by pharmaceutical majors to build critical mass in biologics capabilities.

Yet again, FDA's ability to regulate drugs is under fire. At the core of this latest round of scrutiny is whether the agency has the resources to properly control the safety of new nanotech-based drug products.

The correlation between swab assay results and visible-residue limits (VRLs) for cleaning validation was examined. Previously completed validation studies were reviewed to compare swab results with recently determined VRLs. A current cleaning validation study evaluated both swab testing and VRL. Unexpected swab results led to an investigation, which showed the value of establishing the VRL in conjunction with swab recoveries for cleaning validation programs.

Mid-size regional players have little chance for success in an industry increasingly dominated by large global players.

Here's to all the difficult, out-of-touch, and irresponsible coworkers that make our workplace interesting.

The trend towards developing pharmaceutical products and their manufacturing processes in tandem supports optimized production. Such developments rely on gathering process-relevant information at an early stage and being able to draw on past and current processing experience. Here, we discuss how powder rheometers can make a real difference in building a database of powder properties and removing subjectivity.

Clean rooms are critical areas in bio/pharma facilities, and it is essential that users are responsible for their care and upkeep, and familiarize themselves with the relevant regulations.

The ¤9.5 billion therapeutic antibody market comprises over a dozen antibodies that have been generated using recombinant genetic methods developed over the last 20 years.

This article investigates pharmaceutical applications of terahertz technology, specifically using techniques for solid dosage form analysis such as pulsed spectroscopy (to generate physical information and detect API changes) and pulsed imaging (to locate formulation impurities, and regulate tablet coating quality and thickness).

Robin Hwang, a senior principal scientist at Amgen (Thousand Oaks, CA), led the team that developed the first commercial disposable auto-injector for a biopharmaceutical: a prefilled three-step "SureClick" for delivering Enbrel (etanercept), a treatment for autoimmune diseases.

Increased treatment using combination therapies

CPhI success

CPhI Worldwide, Paris (Oct. 3)-Exhibitors at CPhI Worldwide reported expansions, enhancements in technology, and new projects last week in Paris.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

The specialty excipients market in the United States, Western Europe, and China is valued at nearly $800 million. The authors discuss the opportunities and challenges in these markets by examining the product mix, supply base, and preferred production methods.

Whether you advance your technology from concept to commercialization or use a third party for parts or all of this work, the ability to do technology transfer flawlessly is essential to successful, efficient pharmaceutical production.

Plastic has emerged gradually as a viable packaging material, even for sterile products. Acceptance of plastics has been encouraged by blow–fill–seal (BFS) technology, which provides scientific and commercial benefits. BFS technology has, however, brought new challenges for formulation-development scientists. This article highlights the specific concerns for the development of sterile liquid products and the formulation strategies to address these concerns.

The authors investigated the influence of various particle size fractions of Tamarind seed polyose (TSP) on indomethacin (IND) release from matrix tablets. They assessed the TSP fractions for swelling, density, and flow properties and the IND matrix tablets for tensile strength, friability, and release profile. Release kinetics was evaluated using Higuchi and Peppas equations. The density and flow properties showed that the size fraction affects the suitability of TSP as an entrapment polymer. The release profile showed that the release of IND from TSP matrix is swelling dependent, thereby affecting the kinetics of release.

As custom manufacturers and pharmaceutical ingredient suppliers gather for CPhI Worldwide in Paris, Oct. 3–Oct. 5, industry observers point to a mixed outlook for pharmaceutical custom synthesis. While industry performance for 2006 is better than 2005, the critical question remains the improvement in drug output. The slow rate of approvals of new molecular entities (NMEs) continues in 2006 as Big Pharma seeks to build pipelines of active pharmaceutical ingredients (APIs) through acquisitions, including capabilities in biologics.

Protein formulation specialists have long sensed that something big could be just around the corner. Over the past few decades, countless companies have attempted to bring to market new protein therapeutics that offer improvements-be they more patient friendly, more effective, or easier to manufacture-over traditional formulations. Earlier this year, the launch of Pfizer's "Exubera" pulmonary insulin met this anticipation head on. The fast-acting, inhaled-powder form of recombinant human insulin brought hope to the millions of diabetic patients waiting for an alternative to injections.

This article provides an overview of functionality, functionality-related characteristics, and excipients performance.

Facing cost pressures and regulatory changes, pharmaceutical companies address the need for increased functionality by looking to excipients.

The increasing popularity of orally disintegrating tablets has led to growing interest in the advantages of superdisintegrants. This article presents some practical considerations in selecting these ingredients.