Have Biosimiliars Finally Gained Full Pharma Acceptance?

Pharmaceutical Online Newsletter | February 26, 2015

» From The Editor Pfizer Acquires Hospira: Biosimilars Gain Full Pharma Acceptance By Louis Garguilo, Executive Editor, Outsourced Pharma Just days after Outsourced Pharma's in-depth, two-part article on Hospira and the role of biosimilars in global healthcare, and in which I asked Hospira's Sumant Ramachandra whether he foresaw a future where Pfizer comes to Hospira to work together on biosimilars, we have a definitive answer. QA/QC Comparison Of The Efficacy Of Various Yeast Viability Stains By Stephen E Szabo, Ph.D., Beckman Coulter, Inc. Yeast are single-cell microorganisms that reproduce by budding. A well-known property of yeast is that they are responsible for the conversion of fermentable sugars into alcohol and other by products. WHITE PAPER: A QbD Approach To Freeze Drying Of Cytotoxic Compounds By Dr. Kevin Ward Quality by Design (QbD) is a systematic approach to ensure that the quality of a product is built into production processes from the outset, rather than being tested once development has commenced. CASE STUDY: Terminal Sterilized Product: Validating PQ Of Manufacturing Equipment POSTER: RMM Validation: Development And Qualification Of A Test Chamber And Laboratory TRAINING COURSE: Lyophilization Technology Training Course: April 13 To 15, Boston, MA » Manufacturing WHITE PAPER: The Financial Advantages Of Purchasing Used Equipment And Investment Recovery Services By Matt Hicks, COO The loss of a patent for a branded drug product leads to opportunities for generic biopharmaceutical manufacturers. Once a blockbuster drug reaches the end of its branded life cycle generic manufacturers will gear up to produce lower margin "copies." DATASHEET: Pharmaceutical Containment Booths And Enclosures By Isolation Systems Inc. BROCHURE: Automatic Inline Liquid Filling Systems » Packaging WHITE PAPER: How To Survive An FDA Audit By Paul Dupont, Ropack Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records, and conducting audits more frequently — up from .06 to .09 per year, according to Bloomberg News. WHITE PAPER: Ensuring The Headspace Of A Vial Contains A Specific Gas DATASHEET: Buffer Systems For Blisters And Wallet Packages By Harro Höfliger Packaging Systems » Critical Environments WHITE PAPER: Pharmaceutical Cleaning Strategies: Develop A Quality Procedure By M.L. Bernuzzi, R&D Manager There are many aspects to be considered when approaching the issue of pharmaceutical cleaning. First of all, one has to consider where to perform cleaning activity: in-place (CIP) or out-of-place (COP). APPLICATION NOTE: Basic Principles Of Freeze Drying BROCHURE: Pharmaceutical Vial Washer, RW-500 » Logistics WHITE PAPER: 5 Tips To Minimize Risk In Your Cold Chain Packaging By Jean Bédard, President and CEO, Infitrak As pharmaceuticals have become more and more regulated, companies have had the need to build or evaluate their cold chain processes and packaging to comply with those regulations and minimize risk. CASE STUDY: DHL: Interconnectedness In The Cold Chain By Vivian Berni, LifeConEx  When faced with environmental uncertainties, leveraging a network of trusted partners becomes a critical link in the transportation process for temperature-sensitive medicinal products. WHITE PAPER: A World Of Opportunities: Your Focused Field Guide For Specialty Transport To Emerging Markets » Inspection WHITE PAPER: Deconstructing The Blue Dye Leak Test Method By Oliver Stauffer, PTI Packaging and Inspection Systems Blister package manufacturing for tablets and capsules has process and material parameters that are unique to each product. Barrier properties of blister packaging are primarily designed to eliminate moisture ingress, a result of H2O molecules passing through micro leaks over extended periods of time. WHITE PAPER: Package Leak Testing And Achieving Quality And Efficiency Standards By Dr. Dorian Dixon Achieving excellence in quality and efficiency standards has become the talking point within the pharma industry. BROCHURE: BioTrak Real-Time Viable Particle Counter UPCOMING TRAINING Reducing Human Error In Life Sciences Manufacturing Date: Thursday, February 26, 2015 • Time: 1:00 pm to 2:30 pm EST » Most Recent News Huntingdon Life Sciences And Harlan Laboratories To Operate Under New Brand and Name » Subscribe Today For insight on how pharma and biopharm executives can improve how they run their businesses, subscribe to Life Science Leader magazine. Follow Pharmaceutical Online: