Newsletter | August 12, 2014

08.12.14 -- Predicting Pharma Disposable Facilities; FDA Hikes User Fees For Foreign Pharma Manufacturers

Pharmaceutical Online Newsletter
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.
» Guest Column
Lessons Learned In The Ballroom: Predicting Pharma Disposable Facilities
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?
Featured Focus: Packaging
Sustainable Pharmaceutical Packaging
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.
WHITE PAPER: Drug Safety And Product Protection Driving Blister Packaging Growth
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.
PRODUCT/SERVICE: Pharmaceutical Metal Detection
PRODUCT/SERVICE: X-Ray Inspection System: Cartons, Bags, Foils
PRODUCT/SERVICE: Print And Verification Of Pharmaceutical Cartons
» Inspection
BROCHURE: Versa RxV Pharmaceutical Checkweigher
BROCHURE: Multisizer 4 Beckman Coulter Cell Counter
TRAINING COURSE: Basics Of Tablet Manufacturing And Troubleshooting; Sept. 16 To 18, 2014
» Manufacturing
WHITE PAPER: Aggregation Of Therapeutic Proteins: Causes, Control, Consequences, And Challenges
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.
WHITE PAPER: Serialization And The Drug Quality And Security Act: A Top-Down Synergistic Approach
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).
DATASHEET: Gas Regime Control: Micro-24 Gas Micro Mixer
By Pall Life Sciences - BioPharmaceuticals
DATASHEET: Emphaze AEX Hybrid Purifier
By 3M Purification
DATASHEET: APA-4000 Twin-Head Packet Dispenser
By Multisorb Technologies
BROCHURE: FCDV/FCDM Low-Temperature Biodecontamination Units
» Critical Environments
ARTICLE: Which Is Best For Your Application? Comparing Instantaneous Microbial Detection Technology
PRODUCT/SERVICE: Climate-Control Systems For Controlled Process Environments
PRODUCT/SERVICE: Affordable Raman Analyzer: EZRaman-N
» Logistics
WHITE PAPER: Troubleshooting Tips And Best Practices For Biopharma Temperature Validation/Mapping
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.
CASE STUDY: When It Comes To Shipping Perishables, It's The Little Things That Make A Big Difference
CASE STUDY: "Safety First" In The Distribution Of Valuable Life Sciences Products

Lyophilization: An Introduction To The Scientific Principles
Date: Wednesday, August 20, 2014 • Time: 1:00 pm to 2:30 pm EST
» Most Recent News
NICE Renews Efforts To Prevent Hepatitis
FDA OKs Hovion API Plant Inspection
Eli Lilly Updates Jentadueto Label To Include Phase 4 Data
FDA Hikes User Fees For Foreign Pharma Manufacturers
Kyowa Hakko Kirin Moves Forward With KW-3357
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