Top Stories
In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.
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Intuniv (guanfacine hydrochloride prolonged-release tablets) is the first selective alpha-2A adrenergic receptor agonist licensed for the treatment of attention deficit hyperactivity disorder in Europe.
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Industry News
Piramal says pharmaceutical companies should strive to improve their processes, not just for original patented products but efforts should go beyond DMF and ANDA submissions.
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Exports and domestic market have each been valued at more than US$15 billion.
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Supplier News |
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West Pharmaceutical Services and HealthPrize Technologies are collaborating on self-reporting and bar coding capabilities for injectable drug-delivery systems.
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BASF is working together with top universities to develop a new supersonic spray-drying process for production of stable and soluble amorphous nanoparticles.
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Bio/Pharma News
Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.
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The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.
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Regulatory News
Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.
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Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.
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FEATURED TOPICS |
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QUALITY
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
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MANUFACTURING
The industry is moving towards more flexible manufacturing with the use of modular facilities and single-use systems.
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Tablet quality issues? You need this digital handheld microscope on special for a limited time at
 natoli.com/specials. You’ll find inspection equipment and more in the new edition of Natoli’s Tablet Compression Accessories Catalog – available for download along with Tablet Press Replacement Parts Catalogs on Natoli’s website. |
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Webcasts
Wednesday, Oct. 7 2015 | 2–3 pm EDT
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience |
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Agilent CrossLab –From Insight to Outcome
Laboratories today face complex scientific and business challenges that require key insights into laboratory operations. Agilent CrossLab Enterprise Solutions provide these insights by leveraging laboratory operations data to help you dramatically improve scientific and business outcomes across your local, regional or global laboratory enterprise. Agilent CrossLab Enterprise Solutions -- focused on your organization’s goals.
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On Demand
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.
Sponsored by AMRI
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Calibration and Qualification of Laboratory Instruments in Accordance with GMP Requirements
LIVE WEBCAST: Tuesday October 6, 2015 at 11 EDT/ 15:00 GMT/ 16:00 BST/ 17:00 CET
Calibration, qualification, and the right appropriate level of routine testing for laboratory instruments are critical to ensuring high-quality results and maintaining GMP and USP compliance. Understand the relationship between these factors to optimize testing and be prepared for audit.
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on pharmtech tv
The Future of Dosage Forms
Addressing Drug Quality: Aging Facilities
Building Biopharmaceutical Manufacturing Processes
Collaborative Success Strategies for Biopharm Companies
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Events
October 25–29, 2015 | Orlando, FL, USA
October 27–29, 2015 | Philadelphia, PA
December 08–10, 2015 | Philadelphia, PA
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Establishing a Risk Management Plan for Compliance and Pharmacovigilance
On Deamand
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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.
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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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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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