08.12.14 -- Predicting Pharma Disposable Facilities; FDA Hikes User Fees For Foreign Pharma Manufacturers
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 David A. Wolton and Andy Rayner, ISPE
This article presents an alternative approach to the ballroom concept. It studies the lessons learned from the operation of recently commissioned facilities to predict what the next generation of disposable plants could look like. Will the "dance floor" concept be the next step in the evolution of fully disposable facilities?
By Chuck Reed and Mel Bahr, ISPE Packaging Community of Practice
The concept of sustainability has been a topic of interest for many years. Current international focus has led to the development of regulatory guidance in many of the world’s markets. Along with sterility assurance, process validation, and regulatory compliance, sustainability is becoming a high-profile issue and is considered a critical factor in the design of healthcare facilities, equipment, products, and packaging.
By Paul Dupont, Ropack
Trends in packaging of prescription and over-the-counter drugs indicate continued growth in the blister packaging market. The U.S. blister market size reached $2.58 billion in 2013 and is projected to reach $3.44 billion by 2018. This escalation outpaces the growth of other packaging formats, principally bottling. While key factors driving that trend reflect the ongoing focus by manufacturers on drug safety and protection, others arise from the latest government regulations and the growing voice of the consumer.
By Dr. John Carpenter, University Of Colorado, School Of Pharmacy
Aggregation is one of the most problematic and challenging issues for the development of safe and effective therapeutic protein products.
By Glenn Restivo, Mike Salinas, M&W; and David Dejean, Systech International
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs and the Drug Quality and Security Act (DQSA).
By Paul Daniel and Jon Aldous, Vaisala
The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics. To meet these requirements for temperature or humidity, we perform a mapping validation, usually as part of an installation qualification and operational qualification of the environment, be it: incubator, fridge/freezer, stability chamber, cold room, or warehouse.