Top Stories
Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.
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The purchase will strengthen Hikma’s position in the US generic drug market.
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Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.
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World on the verge of an effective Ebola Vaccine according to WHO.
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eBOOKS
This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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Industry News
Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.
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Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.
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Supplier News
Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.
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The new service offering includes feasibility studies, process and analytical development, and scale-up from milligram to gram quantities required for pilot and subsequent commercial scale.
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Bio/Pharma News
The new biotech company, Mereo, is based in the United Kingdom, and kicks off with three mid-stage assets from Novartis.
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ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.
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Regulatory News
“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.
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FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
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TROUBLESHOOTING
Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.
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Just released – Tablet Press Replacement Parts and Accessories Catalogs
In addition to efficient, durable and highly-performing tablet compression tooling, Natoli Engineering Company also offers tablet press replacement parts for most makes and models of machines as well as tablet compression accessories to clean, maintain, analyze, and protect your tooling. Download a PDF of our new catalogs or request a quote online at natoli.com.
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GMPs
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.
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VIEWPOINTS
As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.
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Webinar Aug. 12th: Using Raman Spectroscopy & LIBS for Automated Particle Identification
Gain insight into the value of using Raman/LIBS for automated particle identification as a fast and effective method for understanding the composition of foreign particles, in addition to learning about some of the most commonly found sources of foreign particulate and witness case study examples of automated particle identification.
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Webcasts
On Demand
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
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. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for analytical testing programs.
Sponsored by: SGS Life Science Services
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Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
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on pharmtech tv
Application of External Lubrication in Tablet Production
Feeding Powders in Pharmaceutical Processes
Focus on Biobetters
FDA Applications and New Guidance Documents
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Events
August 18–20, 2015 | Philadelphia, PA
September 7–9, 2015 | Seoul, Korea
September 28–30, 2015 | Washington, DC, USA
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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 informative, useful articles from Pharmaceutical Technology designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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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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