News

Interphex2007, New York, NY (Apr. 25)-One of the challenges facing pharmaceutical manufacturers is how to implement process analytical technology (PAT) into their commercial manufacturing processes. Michael Abad, engineering section manager, Abbott Laboratories shared insight from a project within Abbott in his presentation "Engineering for PAT" at Interphex today.

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.

Interphex2007 (Apr. 25)-As the pharmaceutical industry moves to a risk-based approach in manufacturing, analytics will play a critical role in not only meeting regulatory requirements but also in building needed collaboration between product development and manufacturing groups.

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.

Interphex2007, New York, NY (Apr. 25)-Interphex will see a new venue in 2008 and be co-located with a biotechnology exhibition. These are some of the changes in store for next year?s installment of the conference and exhibition, including a change in venue for next year?s conference.

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.

Interphex2007, New York, NY (Apr. 24)-Effective project management is critical for successful outsourcing between a pharmaceutical company or sponsor and a contract manufacturing organization (CMO), and the strategies for such success was highlighted at the Interphex2007 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.

Interphex, New York, NY (Apr. 24)-Radio-frequency identification (RFID) technology is an increasingly important tool in the pharmaceutical supply chain. Paul Rudolph of Arent Fox PLLC gave the first of several talks on RFID and e-pedigree at Interphex today in his presentation, "Pedigrees: Update on Federal and State Regulation and Effect on RFID Tagging of Products."

Interphex 2007 Conference and Exhibition, New York, NY (Apr. 24)-Interphex 2007 Conference and Exhibition opened today with nearly 1000 exhibiting companies and record attendance anticipated for the show.

Interphex, New York, NY (Apr. 24)-Compared with other industries such as the automotive industry, the pharmaceutical industry has been slow to adopt lean manufacturing. This situation, however, is changing.

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.

Toronto (Apr. 17)-Patheon, Inc. plans to restructure its current network of six pharmaceutical manufacturing facilities in southern Ontario, Canada as part of its strategy to focus on manufacturing prescription pharmaceutical products and to improve its profitability.

Chalfont St. Giles, UK (Apr. 16)-GE Healthcare, a unit of General Electric, acquired Wave Biotech LLC, a supplier of disposable manufacturing technologies and processing equipment for the biopharmaceutical industry.

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.

London (Mar. 29)-GlaxoSmithKline (GSK) plans to invest EUR 250 million ($334 million) at its production site at Currabinny, County Cork, Ireland over the next five years, according to a release issued by the Irish Development Agency (IDA Ireland, Dublin).

Washington, DC (Apr. 3)-The Synthetic Organic Chemical Manufacturers Association (SOCMA) adopted a policy on Inherently Safer Technology (IST) at its March meeting.

Singapore (Mar. 29)-The contract manufacturing organization Lonza Group (Basel, Switzerland) and Bio*One Capital (Singapore) broke ground for their large-scale commercial mammalian cell-culture manufacturing facility at Tuas Biomedical Park in Singapore.

Thousand Oaks, CA (Apr. 3)-Amgen, Inc. has provided a new schedule for the completion of a new manufacturing facility in County Cork, Ireland.

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.

Washington, DC (Apr. 2)-The US Department of Homeland Security released an interim final rule that imposes federal security regulations for high-risk chemical facilities.

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.