Newsletter | February 26, 2015

02.26.15 -- Have Biosimiliars Finally Gained Full Pharma Acceptance?

Pharmaceutical Online Newsletter
» 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
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