Sep 30 2016

Pharmaceutical Manufacturing Resource #forest #pharma

#pharmaceutical manufacturing magazine


The life sciences industry has undergone many changes over the last decade, with consolidation, mergers, and acquisitions across both small and large pharmaceutical and biotech companies. One result of these changes is complex supply chain models, with a combination of in-house and outsourced research, product development, and commercial operations. The level of complexity has presented challenges for stakeholders and their supply chain partners: suppliers of materials, components, and packaging, as well as contract research (CRO), contract manufacturing (CMO), and logistics service providers.


I didn t quite buy into the DCAT announcement regarding its departure from the Waldorf Astoria, the long-time central location for DCAT Week in New York City each spring. Call me cynical a degree in public relations can do that but I just couldn t believe checking out of the Waldorf would be as easy as it sounded. I took this cynicism directly to Margaret Timony, Executive Director of the Drug, Chemical Associated Technologies Association.

A few weeks away from Outsourced Pharma San Diego. we re already into provocative discussion on outsourcing of drug development and manufacturing. Everything from the role of finance managers in CMOs; pharmacists in biopharma; Car-T and personalized medicine in development; the FDA in foreign lands; and project managers in situ. Frank Sorgi, Ph.D. President and CEO of FLAG Therapeutics, Inc. leads the charge.

We re entering our era of technology. It s transferring preeminence from science to tech innovation. New players will enter; traditional biopharma will retool. Tech implementation of all hues will coalesce in the outsourcing model. Gr nenthal of Aachen, Germany, is a leader in this new paradigm. Alexander Kraus, VP Product Development, Technical and Government Affairs, Gr nenthal USA, Inc. explains how and why.

Forget presidential elections. We ve got the debate we were looking for. The one on the professionalism of project management in the biopharma industry. It includes a reader s comments that start with: I call BS on this article. The prosecuting paragraphs are copied below for careful dissecting. Vitriol can be valuable.

Gary Gilleskie graduated with a Ph.D. in chemical engineering, went to work at a CMO, and became senior director for downstream manufacturing and process development. Now he s back on campus to ensure part of his history isn t repeated: obtaining that first job in biomanufacturing without a solid background in the industry.


  • Upcoming Webinar: The Implications Of Inaccurate Forecasting In Biologic Drug Substance Manufacturing And Strategies To Mitigate Risks: A Live Discussion
  • Sartorius Stedim Biotech Presents First Fully Integrated Upstream Platform
  • CSafe Announces Acquisition Of Kalibox
  • ‘Considerations For Implementing Single Use Filling Systems’ Session Announced For Pharma Expo Conference
  • Mettler Toledo Plans State-Of-The-Art New Facility In Tampa Bay Region

More Industry News



Pharmaceutical manufacturers now have the ability to analyze massive amounts of quality, environmental, and IoT-generated factory data, which enables them to build end-to-end process controls resulting in higher-quality products, more predictability, more efficient manufacturing, and faster time to market.

Welcome to the industry s first Temperature Assurance Packaging (TAP) Certification Program developed by Sonoco ThermoSafe s ISC-Labs in partnership with The Packaging School, Dr. R. Andrew Hurley, Assistant Professor of Packaging Science at Clemson University, and an advisory panel of pharmaceutical manufacturers, wholesalers, logistics providers, and industry experts.

The global countdown to serialization compliance is well underway. Early adopters, such as Turkey and Argentina, required serialization as early as 2010, and were followed by others such as India, China and Korea. Over the next three years, many other major markets will require adherence to their own serialization requirements, including the United States and the European Union. Expect that by 2018, serialization mandates will govern most of world s drug supply. Biopharmaceutical companies that don t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

As evidenced by the growing number of research publications, clinical trials, newly launched companies, and news stories, the Veterinary space is quickly becoming a major player in the application of regenerative medicine technologies.

A centrifuge is an integral component of a laboratory that is critical to the success of an analysis. They come in a variety of sizes, from mini-centrifuges that hold only a few small tubes and spin a few thousand RPM to high capacity centrifuges that hold up to 6 liters of samples to ultracentrifuges that spin upwards of 100,000 RPM. Multiple options in size as well as other areas can make choosing the right centrifuge for your application an overwhelming task.


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