ISPE links with university for hands-on biopharma training

By Pete Mansell

- Last updated on GMT

Related tags: Biotechnology

The International Society for Pharmaceutical Engineering (ISPE) is
offering a "unique training experience" for pharmaceutical
professionals through a partnership with North Carolina State
University in the US.

The big draw is the universitys Golden LEAF Biomanufacturing Training and Education Centre (BTEC) in Raleigh, North Carolina. This means the training programme scheduled for 12-14 May 2008 at BTEC can provide hands-on experience in a facility that replicates a biomanufacturing pilot plant capable of producing biopharmaceuticals and packaging them in a sterile environment. Currently BTEC is the only facility in the US that can do this from inoculation to filling, ISPE points out. Opened in September 2007 to educate and train future employees for the US states growing biomanufacturing industry, the 86,000sq ft facility includes more than 63,000sq ft of laboratory training space, bioreactors and associated control systems, downstream separation and purification processes, and aseptic processing operations. It also incorporates numerous bench-scale laboratories for learning about next-generation biomanufacturing technologies such as disposables, animal cell and tissue culture, cell therapy, protein and metabolic engineering, miniaturisation, high-throughput technologies and bioanalytical methodologies. Developed for professionals in the pharmaceutical manufacturing and biotechnology industries, the training programme will offer four three-day courses including lectures, problem-solving workshops and hands-on activities at BTECs state-of-the-art current Good Manufacturing Practice (cGMP)-standard pilot plant. Among the topics lined up are process validation for biotechnology manufacturing; biopharmaceutical manufacturing facilities; getting the most from your bioreactor; and disposables in biomanufacturing: an objective assessment. Participants will be able to earn Continuing Education credits and several of the courses include information related to competencies for the ISPEs Certified Pharmaceutical Industry Professional (CPIP) credential. Information about specific courses and instructors is available at​. The Society has also announced the formation of a new PAT Community of Practice (CoP) Steering Committee for the ISPEs D/A/CH region (Germany, Australia and Switzerland). The regional committee was established at the 8th meeting of the Societys PAT CoP held at Boehringer Ingelheim in Germany. The aim, ISPE explained, is to help the pharmaceutical industry plan and implement a systematic PAT (Process Analytic Technology) approach so as to ensure high drug quality at a reasonable cost. A Steering Committee for the D/A/CH region is seen as a useful tool for optimising communication between international Communities of Practice, external parties and regulatory bodies, and for creating an organisational platform to move forward internal activities. The nine committee members are drawn from pharmaceutical companies and suppliers including Boehringer Ingelheim, Werum, Merck Serono, Pionit and Bayer Technology Services.

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