by Oliver W. Mueller, Glatt Pharmaceutical Services

On September 18th – 20th, 2007, Glatt Pharmaceutical Services USA, a leading provider of solid dosage form product development, drug delivery technology and contract manufacturing offered the inaugural presentation of its “Industry Trends in Controlled Release Dosage Form Development Symposium” to the pharmaceutical industry for the design, development, scale-up and manufacture of controlled release products.

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Over 50 pharmaceutical industry professionals from all areas engaged in solid dosage controlled release R&D, manufacturing and marketing were in attendance at this intensely focused, comprehensive and insightful symposium.

Glatt Pharmaceutical Services assembled an impressive roster of world-renowned thought leaders on the topic in question, who presented on contemporary approaches to dosage form design, in-vitro/in-vivo correlation issues, process development and scale-up, as well as regulatory, legal, and market demographic discussion points related to controlled release dosage forms. The line-up of speakers included:

Mark McClellan, M.D.
former Commissioner, US Food and Drug Administration,
Senior Fellow at the AEI - Brookings Joint Center
Gordon Amidon, Ph.D.
University of Michigan
Stephen Byrn, Ph.D.
Purdue University
Reza Fassihi, Ph.D.
Temple University
Edgar Haug
Frommer Lawrence & Haug LLP
Ajaz Hussain, Ph.D.
Sandoz
David Jones
Consultant and formerly with Glatt Pharmaceutical Services
Doug Long
IMS Health
Norbert Pöllinger, Ph.D.
Glatt GmbH
Robert Pollock, R.Ph., M.S.
Lachman Consultant Services
Armin Prasch, Ph.D.
Glatt GmbH
Harald Rettig, Ph.D.
BioVista LLC
Orapin Rubino, Ph.D.
Glatt Pharmaceutical Services
Burkhard Schluetermann, Ph.D.
ADD Technologies
Vinod Shah, Ph.D.
Pharmaceutical Consultant

Dr. McClellan provided the keynote address for the symposium entitled, “The Role of Pharmaceutical Manufacturing in Improving Health Care”, and stressed the importance of innovative manufacturing methods and approaches, such as controlled release dosage formulations, in the improvement of medicinal health remedies and in lowering health care costs.

The symposium was a great success as distinguished speakers and attendees together explored the challenging, important and rewarding world of solid dosage controlled release products. Feedback was resoundingly positive, with all participants departing the intensive session more enlightened on the myriad of issues surrounding controlled release dosage forms then they may have had when they arrived three days earlier!

Glatt Pharmaceutical Services plans to sponsor this symposium again within the next year. Please contact US 001-201-825-8700 and ask for the Seminar Coordinator for further information.

On September 19, 2007, Glatt Pharmaceutical Services USA, hosted over 350 pharmaceutical industry professionals at its “New Solid Dosage Facility Inauguration and Open House Celebration” in Ramsey, New Jersey.

The Open House Gala and Reception was graced with a diverse roster of guests including, numerous Glatt customers and partners who benefit daily from the broad array of high quality and innovative products and services offered by Glatt, an impressive cast of pharmaceutical industry thought leaders who served as speakers at Glatt Pharmaceutical Services’ “Industry Trends in Controlled Release Dosage Form Development Symposium”, conducted concurrently with the Open House event on September 18th – 20th, Glatt’s many business associates providing support and services to its operations in Ramsey, NJ, and visiting International Glatt Group VIP’s and colleagues with whom the staff in Ramsey, NJ collaborate to bring world-class technologies, equipment and services to the US pharmaceutical industry.

Of course, front and center was Herr Werner Glatt, Founder and Former CEO of the International Glatt Group, who was beaming with both pride and enthusiasm over the day’s activities and the new Ramsey, NJ solid dosage R&D and manufacturing facility which served as both the “host and honoree” of the celebration! Herr Reiner Nowak, current President and CEO of the International Glatt Group, was also in attendance and is credited for having “ordered” the glorious and perfect late summer weather bestowed upon the occasion and all of its honored guests and participants! Thank-you Herr Nowak!

The Open House Gala was highlighted with a keynote address by Mark B. McClellan, M.D., former Commissioner U.S. Food and Drug Administration, entitled, “The Role of Pharmaceutical Manufacturing in Improving Health Care”. Dr. McClellan reminded the many pharmaceutical R&D and manufacturing professionals in attendance why their work is a critical part of re-shaping the national health care landscape. Dr. McClellan emphasized that new manufacturing methods and innovations, such as controlled release formulations, are having a measurable and positive impact on the quality of human healthcare, improving the treatment of chronic pain, cardiovascular disease, high cholesterol, and various other serious and quality-of-life health conditions. He also discussed modernization and the use of Quality Systems within the FDA and the industry, and their importance in facilitating the manufacturing innovation and efficiency needed to participate in reducing health care costs.

Controlled release solid dosage forms do indeed play an increasingly important role in establishing a well balanced portfolio of medicinal treatments, offering enhanced efficacy, improved patient compliance, reduced patient cost and product life-cycle management, to companies engaged in offering both branded new chemical entity and generic pharmaceuticals to health care providers and patients alike. For over 50 years, Glatt has partnered with the pharmaceutical industry to bring the most challenging solid dosage products to the market, including controlled release dosage forms. Today, with Glatt Pharmaceutical Services’ recently completed state-of-the-art facility and its corresponding expanded staff and depth of knowledge, Glatt is poised to assure its past, present and future clients and partners of its continued commitment to unrivaled R&D and manufacturing capabilities.

In fact, the newly expanded and renovated facility in Ramsey, New Jersey concentrates on complex controlled release products and features Glatt’s world-renowned Wurster HS™ coating and drug layering system, Glatt’s proprietary CPS™ pellet system, Glatt fluid bed and high shear granulation, Glatt fluid bed drying, Glatt and other blending, tablet compression, encapsulation, Glatt perforated pan coating, organic solvent coating capability, controlled substance handling and a fully-equipped and modern analytical testing laboratory.

The mission of Glatt Pharmaceutical Services is to “strive to be the global leader in the development and manufacture of difficult-to-craft modified and immediate release solid dosage products, under the highest levels of cGMP, quality and efficiency standards, and with the utmost care and attention to unparalleled customer service and satisfaction.” The “New Solid Dosage Facility Inauguration and Open House Celebration” underscored Glatt’s dedication, resolve and readiness to accomplish this lofty mission.

In addition to Dr. McClellan, remarks from Werner Glatt, Oliver Mueller, Executive Vice-President Glatt Pharmaceutical Services, Stephen Sirabian, Executive Vice-President Glatt Equipment & Engineering Services and Christopher C. Botta, Mayor Borough of Ramsey, were offered. The presentation portion of the event was capped off by a traditional Ribbon Cutting Ceremony, where Werner Glatt and Reiner Nowak were accompanied by Mayor Botta and various senior management staff members of Glatt Air Techniques, Inc. With the ribbon successfully and precisely (would you expect less from a German company?) cut, the new facility was officially inaugurated and all in attendance were invited to participate in an Open House Walking Tour of the 86,000 ft2 plant, designed, engineered and constructed by Glatt’s US turnkey engineering operation, Ramsey Design Group.

As the day moved into evening, the affair was capped-off with a cocktail and hors d’oeuvre reception, where truly fantastic food and libations were shared with the scintillating sound of live concert piano music playing in the late summer air! What could be better? Good food, drink, entertainment and camaraderie among friends pursuing the common mission of improving health care throughout the world!

		Oliver W. Mueller is the Executive Vice-President of Glatt’s USA Pharmaceutical Services Division. In this capacity, he is responsible for R&D, Contract Manufacturing, Regulatory Compliance, QA/QC, Plant Operations, Sales and Business Development. He joined Glatt Air Techniques, Inc. in 1985 and has held various positions in both the Pharmaceutical Services and Equipment Sales & Engineering divisions at the Ramsey, New Jersey operation. He holds a B.S. degree in Chemical Engineering from Lafayette College. Email: omueller@glattair.com