Pharmaceutical Technology Editors

Washington, DC (April 30)-Less than two weeks after the Senate Health, Education, Labor, and Pensions Committee voted to reauthorize the Prescription Drug User Fee Act (PDUFA), the bill this week moved onto the Senate floor.

Geneva, Switzerland (Apr. 27)-A meeting of the World Health Organization and the Committee for Medicinal Products for Human Use's approval of Novartis's new cell culture-derived influenza vaccine offered new hope that sufficient numbers of vaccines could be produced in case of a pandemic.

Albany Molecular Research, BAC, Crucell, More

Sanofi to Close Irish Plant, FDA Inspections and Warning Letters Continue to Decline, FDA Submits Final Proposals for PDUFA IV, and more.

A roundup of company moves and positioning from the pharmaceutical industry and biotechnology industries and contract service providers.

BioConvergence, PharmaFab, Johnson & Johnson, More

San Juan, PR (Apr. 25)-Regulatory and quality issues were prominent discussion topics at this year?s ExcipientFest conference and exhibition.

Exhibitor News-Day 3

Interphex2007, New York, NY (Apr. 25)-The future of the life science industry lies in biotechnology, and the industry is set to see more heated debates on healthcare and drug safety, according to G. Steven Burrill, chief executive officer of Burrill & Company, who presented today?s keynote address, "The Future of the Life Science Industry."

Interphex2007, New York, NY (Apr. 25)-As manufacturers prepare for processing more-potent compounds, they seek effective clean-in-place (CIP) and wash-in-place (WIP) design systems.

Interphex2007, New York, NY (Apr. 25)-As governments begin to contemplate the possibility of biological terrorism or a pandemic event, a new problem begins to emerge: in the case of a pandemic or an attack, even if a vaccine or treatment exists, how could it be produced in sufficient numbers to prevent the deaths of millions of people? That question was addressed in at the conference session, "Responding to Bioterrorism and Pandemic Events: A Case for Development of Flexible Manufacturing Space for Vaccine Production," at Interphex today.

Interphex, New York, NY (Apr. 25)-Problems caused by the presence and movement of air in pharmaceutical powders are increasing, and many times these problems can be avoided. James K. Prescott, senior consultant at Jenike & Johanson reviewed these problems in his presentation, "Interstitial Air Effect on Powder Flow," at the Wednesday conference session at Interphex.

Interphex, New York, NY (Apr. 24)-Although the second revision of 21 CFR Part 11, the Electronic Records and Signatures Rule, has not been finalized, there is some progress being made. This was the topic of a presentation given by John English, manager of computer system validation for BE&K BioPharm at today?s Interphex Pharmaceutical Manufacturing Conference and Exhibition.

Interphex, New York, NY (Apr. 24, 2007)-Summarizing the current state of the outsourcing industry, Jim Miller, president of PharmSource Information Services said "It's the best it's ever been and seems to be getting better."

Interphex2007, New York, NY (Apr. 24)?Reflecting the advances of the pharmaceutical industry as a whole and the success of individual companies in the growth of the pharmaceutical industry, Bill Cook, founder and CEO of Cook Group Inc. in a keynote address at Interphex2007 described the benefits of keeping a company private and touched on the future of medical devices.

Adventrx, Hyaluron, MedImmune, Novartis, More

Lyon, France (Apr. 17)-Sanofi Pasteur, the vaccine division of the Sanofi-Aventis Group, announced that the US Food and Drug Administration has licensed its H5N1 vaccine, making it the first avian-influenza vaccine for humans in the United States.

Billerica, MA (Apr. 13)-Millipore Corporation has become the first company to integrate radio frequency identification (RFID) technology with the filtration products used to manufacture biopharmaceutical drugs.

Rockville, MD (Apr. 5)-The US Food and Drug Administration concluded its reinspection of Wyeth?s manufacturing facility in Guayama, Puerto Rico. Conditions at the Guayama facility prompted a Warning Letter in May 2006.

Abbott, Cardinal, Illumina, more

Washington, DC (Apr. 5)-The Pharmaceutical Research and Manufacturers of America joined the debate on follow-on biologics when senior vice-president Caroline Loew issued a statement recommending caution.

Vetter, AAI, Merck, Eli Lilly, More

Brussels, Belgium (Mar. 22)-The European Commission?s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.

Rockville, MD (Mar. 1)-The number of US Food and Drug Administration inspections of biologic and drug-manufacturing facilities declined to 4237 in fiscal 2006, according to a report by the Office of Regulatory Affairs.

BIO Raises Concerns About Studies on Follow-On Biologics; Green Chemistry Reduces Costs and Waste; Novel Polymer–DNA Delivery System; WHO Stresses Lack of Capacity for Pandemic Flu Vaccine; EGA Concerned About Regulatory Workload in Approving Generics

Indian pharmaceutical machine manufacturers (IPMMs) are exceptional among their foreign counterparts. Historically similar to the Chinese with regard to copycat practices, patent infringements, and substandard quality, the IPMMs have made great strides in innovation and collaboration to break free from the shackles of this paradigm.

Agawam, MA (Mar. 26)-Contract manufacturing and testing laboratory Microtest signed a manufacturing deal with Antisoma to produce AS1411, a new drug being developed for the treatment of various cancers.

South San Francisco, CA (Mar. 28)-Genentech, Inc. announced plans to invest $140 million in 1000-liter manufacturing facility in Singapore.

Washington, DC (Mar. 26)-The congressional Committee on Oversight and Government Reform held a hearing to evaluate the cost of biotech drugs as well as strategies for establishing an approval process for the US Food and Drug Administration approval of generic versions of these drugs.

Improving performance at an active pharmaceutical ingredient manufacturing plant involves an integrated approach that incorporates methods for optimizing total production management, quality control and assurance, and inventory management. The authors analyze results from a recent benchmarking study to evaluate the critical success factors in high-performing API manufacturing plants.