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Top Stories
As FDA advisory committees meet on two potential PCSK9 inhibitors, Prime Therapeutics analyzes the impact that this class of drugs may have on overall drug spending.
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In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”
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Subscribe Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.
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Survey We want your feedback on trends in finished product manufacturing and innovation in pharmaceutical equipment.
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Industry News
Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.
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CPhI Pharma Insights' Turkey Market Report reveals, the growth and strategic plans for the future of the pharmaceutical industry in Turkey.
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Supplier News
Lyophilization Services of New England announces inspection approvals that will allow its Bedford, NH facility to manufacture commercial drugs.
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A year after its merger with DSM Pharmaceutical Products, Patheon announces that it has filed an IPO.
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The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
Learn some key elements to spotting a good FDA Compliance solution, techniques for achieving Good Manufacturing Practice (GMP) Compliance, and how to ensure that Quality and Compliance are met in the Life Science industry.
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Bio/Pharma News
The Green Cross facility in Canada will produce intravenous immunoglobulin and albumin.
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The pediatric investigation plan provides a clinical development plan for Viaskin Peanut in pediatric population.
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Regulatory News
The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.
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FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.
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Achema 2015 Messe Frankfurt Halle 3, Stand A47
Weiler Engineering, Inc.'s corporate focus is to provide advanced aseptic liquid processing technology through application of customized ASEP-TECH® Blow/Fill/Seal machinery and services.
ASEP-TECH® Blow/Fill/Seal machines incorporate the three-step process of blow molding, aseptic filling, and hermetic sealing of liquid products in one compact machine frame.
Weiler is located in a 140,000 ft2 plant near Chicago O'Hare International Airport in the USA.
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MANUFACTURING
Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.
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TROUBLESHOOTING
Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.
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PEER-REVIEWED
Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.
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Addressing Formulation Needs with A different Technology:
Say “Hello” to Ion Exchange Resins
Live Webcast: June 24, 2015 at 9:00 AM EDT 14:00 BST & 15:00 CEST
Ion exchange resins have long been in the formulator's toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
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Webcasts
Tuesday, June 16, 2015 at 11 am EDT | 8 am PDT | 16:00 BST | 17:00 CEST
Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.
Sponsored by: Thermo Fisher Scientific
Wednesday, June 17, 2015, 2 pm EDT | 11 am PDT
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by: Tosoh Bioscience LLC
On Demand
The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world.
Sponsored by: SGS Life Science Services
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Trends in Quality
Agreements & Communications: A CMO Perspective
Live Webcast: Tuesday, June 23, 2015 at 11:00 am EDT
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO¬/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.
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on pharmtech tv
Focus on Biobetters, Part 1
Feeding Powders in Pharmaceutical Processes
Reducing the Cost of Drug Manufacturing
FDA Applications and New Guidance Documents
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Events
June 15-18, 2015| Philadelphia, PA USA
June 23–24, 2015 | Bethesda, MD
July 16, 2015 | New Brunswick, NJ
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling
On Demand
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
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REFERENCE BOOKS
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A compilation of articles from Pharmaceutical Technology in a three-handbook set covering methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. / Learn more /
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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eBOOKS
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This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.
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