Top Stories
GSK reports no employee injuries at the facility and is assessing damage.
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Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments.
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Industry News
The company adds a few new arguments—as well as new stakeholder support—to its Citizen Petition on biosimilar naming.
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Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.
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Supplier News
With this acquisition, Source BioScience is now able to offer integrated solutions to customers, with environmentally controlled storage in combination with the required up- or downstream analytical testing services.
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WuXi PharmaTech and TruTag Technologies successfully applied and detected TruTag's edible microtags on solid-dosage drug products and found no effect on dissolution.
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Bio/Pharma News
The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.
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The company is in discussions with Europe's Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.
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Regulatory News
FDA's Center for Drug Evaluation and Research provides guidance on development plans for botanical drugs.
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The agency issued guidance regarding common issues involved with the development of treatments for rare diseases.
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GLOBAL REPORT
China's emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.
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VIEWPOINTS
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.
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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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QUALITY
Challenges related to the reporting of out-of-specification results loom for contract testing laboratories.
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ANALYTICS
After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action.
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E-Book: Bioprocessing and Sterile Manufacturing
The editors examine novel technologies for the development, manufacture, purification, and delivery of small- and large-molecule drugs, including single-use systems, lyophilization, andmicrobial monitoring. Aging facilities and the future of aseptic processing are featured topics.
 Click here for your FREE download! |
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Webcasts
On Demand
As challenging new formulations are developed, how prepared is your team to optimize the formulation performance in encapsulation? This webinar will provide insight into improving productivity in the use of capsules for pharmaceutical products for both the formulator and supply chain. Capsule filling technologies, dosing options, excipients, capsule selection, and other factors will be discussed. An example from the field will illustrate encapsulation practices.
Sponsored by: Capsugel
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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 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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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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on pharmtech tv
The Transition from Paper Records to Electronic Batch Records
Working with CMOs and CDMOs
FDA Comments on Continuous Manufacturing
Compliance and Technology for Track and Trace
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Events
September 7–9, 2015 | Seoul, Korea
September 28–30, 2015 | Washington, DC, USA
September 28–30, 2015 | Las Vegas, NV, USA
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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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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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