Top Stories
GlaxoSmithKline has temporarily shut down its manufacturing plant in Zebulon, North Carolina after Legionnella bacteria was found in a stand-alone cooling tower during routine inspection.
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The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.
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Following a divestiture of certain assets in Europe, the acquisition of Sigma-Aldrich by Merck KGaA will be complete.
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CPHI PHARMA AWARDS
The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development. Deadline extended to August 14, 2015.
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Industry News
Unlike pharmaceutical manufacturing in the West, China's growth is not merely a result of the increasing sales of finished formulations in highly regulated markets.
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Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications and the industry has only scratched the surface of what might be possible.
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The company's Scotland-based facility has successfully completed a scheduled inspection by the UK's MHRA; there were no critical or major observations noted.
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This new range includes antibodies conjugated to various enzymes, fluorescent dyes, and colloidal gold, for improved flexibility in experimental design.
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Bio/Pharma News
Deal includes rights to Inovio's INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.
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Regulatory News
FDA issues guidance regarding fees for drug compounding outsourcing facilities.
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Flexion will have a dedicated manufacturing suite at Patheon's Swindon, England facility for Flexion's osteoarthritis steroid drug product.
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MANUFACTURING
The 2015 survey says satisfaction is high and continuous manufacturing and PAT use are growing but may be limited by lack of knowledge and experience.
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OUTSOURCING
Contract research, development, and manufacturing organizations (CROs, CDMOs and CMOs) are embracing lean manufacturing, while Big Pharma is applying it, not so much for inventory management, but to improve supply chain visibility and control.
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INGREDIENTS
Ignoring a contract partner's ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.
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PACKAGING
Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.
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A Guide to Applying the Four Pillars of ICH Q10
The Pharmaceutical industry has an obligation to deliver products to market of the utmost level of quality and safety. Anything less and these companies risk facing recalls, losing creditability and brand equity, as well as revenue.
Read this white paper to learn about the basics of the ICH Q10 model, the four pillars of ICH Q10 and how to apply them within your organization.
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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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Webcasts
On Demand
This webcast invites all pharmaceutical scientists and formulators from R&D and analytical departments that have an interest in the solubilization of poorly soluble drugs, and in understanding the importance of choosing a proper dissolution method in the solubilization tests to reveal the full potential of the tested solubilization method.
Sponsored by: BASF
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On Demand
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.
Sponsored by: Dow
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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
Compliance and Technology for Track and Trace
QbD in Excipient Selection for User-Friendly Dosage Forms
Intelligent Approaches Towards Reducing the Costs of Drug Manufacturing
FDA Comments on Continuous Manufacturing
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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 articles Pharmaceutical Technology in a three-handbook set covering general analytical testing and stability in the manufacture, packaging, storing, and testing of formulated products.
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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 features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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