Top Stories
Merck relaunches brand identity to reflect transformation into a science and technology company.
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Senator McCaskill deemed J. Michael Pearson's response letter on drug pricing “inadequate.”
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Industry News
The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.
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Through the Glycoscience Program, the National Institute of Health will contribute $10 million to advance the study of carbohydrates and the compounds that interact with them.
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Supplier News
Hovione acquired a formulation facility adjacent to its current process chemistry and particle engineering facility in Loures, Portugal.
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Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.
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Bio/Pharma News
Athenex will build two facilities for high-potency, oncology API ingredients in Chongqing, China.
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Under the terms of the agreement, Hikma will have the exclusive rights to register, distribute and market Zevtera in the Middle East and North America.
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Regulatory News
FDA issued a warning letter to API manufacturer Unimark Remedies Ltd. for cGMP violations at its facility in India.
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The agency gives an update on the regulation of combination medical products.
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Don't overpay for tablet press replacement parts.
Natoli Engineering stocks an extensive inventory of tablet press replacement parts and turrets for virtually all press types that outlast, outperform, and are less costly than original equipment manufacturers' parts. Download Replacement Parts Catalogs for Cadmach, Colton, Fette, Kikusui, Kilian, Korsch, Manesty, Natoli and Stokes machines online or request a quote through our website.
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FEATURED TOPICS |
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FORMULATION
High-throughput dynamic light scattering effectively screens for optimal ADC formulations by investigating the effects of buffer conditions and temperature on aggregation.
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REGULATIONS
This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
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Technology Transfer from a CDMO Perspective
Joe Cobb, CPIP, director of pharmaceutical development at Metrics Contract Services, recently shared industry challenges from the contract manufacturing side of the industry on tech transfer, which continues to be one of the main challenges of the pharmaceutical industry when it comes to outsourcing.
 Learn more and view Cobb's presentation at metricsinc.com. |
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AAPS 2015 EXHIBITOR GUIDE
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GlobePharma has spent 20 years Innovating the Industry Standard.
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Mikart specializes in the development, manufacturing, and packaging of solid-dose and liquid-oral dose products.
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Patheon is a leading provider of contract development and commercial manufacturing services to the pharmaceutical and biotechnology sectors.
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PYRAMID offers the pharmaceutical and biotech industry both analytical and manufacturing support capabilities.
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Shimadzu is a world leader in the analytical instruments industry.
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Suheung Capsule has solely focused on manufacturing the highest quality Capsules.
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Optimizing M&A Integration for Custom Success: The CMO Perspective
LIVE WEBCAST: Thursday, October 29, 2015 at 9:00 am ET
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Webcasts
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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Thermal Sintering for Controlled Drug release of Hydrophilic Drugs
LIVE WEBCAST: Thursday, October 22, 2015 at 10 am EDT
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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.
Sponsored by Patheon
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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
The Human Element in Pharma Manufacturing
Biologics Development and Manufacturing Trends
Collaborative Success Strategies for Biopharm Companies
A Conversation with AAPS Executive Director, Walt Marlowe
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Events
October 27–29, 2015 | Philadelphia, PA
November 3, 2015–November 3, 2015 | Vienna
December 08–10, 2015 | Philadelphia, PA
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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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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
more ebooks |
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