08.19.14 -- WHO Prepared To Use Experimental Treatments On Ebola Patients
Life Science Leader and BayBio bring you interactive panels on the challenges to managing outsourcing relationships. Panelists include Andy Skibo (RVP, AstraZeneca; EVP, MedImmune), David Lowndes (SVP, Shire), Bob Kanuga (VP, Merck), Junning Lee (SVP, Theravance Biopharma), Terry Novak (COO, Pernix Therapeutics), and others. Learn more.
By Louise Garone, Consulting Principal Analytical Scientist, Enterprise System Partners
Recent changes to the U.S. Pharmacopoeia in relation to technology transfer bring positive implications for pharmaceutical manufacturing. Louise Garone of ESP discusses the critical path for efficient pharmaceutical development.
By Dr. Kevin Ward, Biopharma Technology Limited
Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced.
By Marc Klingler, Segment Manager Hygienic Processing, Bürkert Fluid Control Systems
Thanks to high functionality within minimal space, multiport valves ensure compact processes, facilitate excellent cleaning, and increase process reliability — thereby contributing to improved product yield.
By Jane Metcalfe, BSc (Hons), MSc, Field Applications Specialist, Bioquell UK Ltd
This white paper focuses on the challenges facing modern oncology pharmacies concerning the aseptic preparation of cytotoxic drug compounds. It considers the current regulatory as well as the health and safety issues faced by pharmacists and details some of the measures to tackle these problems, such as the use of isolator technology and the application of good manufacturing practice and quality risk management principles.
By George Bovenzi, Director of Quality; and Steve Pitolaj, Principal Engineer; Garlock Sealing Technologies
The pharmaceutical industry is global in scope and subject to international standards, such as International Standards Organization (ISO) 9001:2008, which establishes the requirements for quality management systems. Compliance with this standard is completely voluntary, but increasingly, major global pharmaceutical companies are requiring their suppliers to be registered by an accredited, third-party registrar or certified by self-auditing; the former being preferable. These suppliers include manufacturers of sealing products used in the industry’s production processes.
By Annette Kaya, Andrea Uebele, Anke Seeger, et al., M+W Process Industries
Contract manufacturer DSM Biologics, at its current good manufacturing practices (CGMP) facility in Groningen, The Netherlands, provides services for clinical development and commercial production based on mammalian cell culture technology.
By Stefan Schneid, Ph.D., Freeze-Drying Focus Group, University of Erlangen, Germany
Laboratory-scale freeze dryers are used for lyophilization of small amounts of product, either for simple preparation of relatively robust materials or for cycle development and subsequent transfer to a larger scale. If the lyophilization process developed is to be scaled up later on, it is beneficial if the freeze dryers employed on the various scales are constructed similarly.