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Top Stories
Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.
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Takeda received a $38 million grant from the Bill & Melinda Gates Foundation to develop, license, and supply Sabin-strain inactivated poliovirus to more than 70 developing countries.
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Industry News
CPhI China is expected to bring together approximately 35,000 attendees from more than 120 countries worldwide.
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The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.
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Supplier News
The company’s Aramus bags are made of an innovative material that is unlike that of the material currently used in commercial single-use bags.
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The new facility will produce GMP film coating productions for the pharmaceutical and nutritional markets in South America.
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The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many.
Learn some key elements to spotting a good FDA Compliance solution, techniques for achieving GMP Compliance, and how to ensure that Quality and Compliance are met in the Life Science industry.
 Learn more |
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Bio/Pharma News
Under the terms of an agreement with Pfizer, WAVE will advance up to five programs from discovery through the selection of clinical candidates.
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Natoli Engineering's Basics of Tablet Manufacturing & Troubleshooting course, June 14-16, is designed specifically for tablet compression industry professionals. Who will benefit? Tooling technicians, tablet press operators, tablet press maintenance technicians, QC/QA personnel, research and development, and their supervisors. Through a series of lectures and hands-on workshops led by top industry experts, attendees will learn firsthand how to minimize downtime by troubleshooting compression problems.
 Sign up TODAY! |
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Regulatory News
The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.
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The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.
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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
LIVE WEBCAST: Thursday, June 23, 2016 at 11:00 am EDT
 Free registration |
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MANUFACTURING
Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.
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ANALYTICS
The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
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Bio/Pharma in China
New Initiatives, New Opportunities
TWO LIVE EVENTS - Part 1: Wednesday, May 18, 2016, and Part 2: Thursday, May 19, 2016 at 8:00 am PDT | 11:00 am EDT | 4:00 pm BST | 5:00 pm CEST
 Free registration |
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PEER-REVIEWED RESEARCH
This article examines using experimental design methods to define different procedures for intermediate bulk container cleaning. The authors have evaluated this new approach, in which a highly soluble, low-dose product and a relatively insoluble high-dose product constituted experimental input variables.
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QUALITY
As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.
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Employing a Lean Lab Approach to Optimize Lab Processes:
Part 1: Work Smarter Not Harder
On Demand
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Webcasts
On Demand
New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules and early research into HPMC’s role as a functional excipient.
Sponsored by Capsugel |
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The Top 4 Most Expensive Encapsulation Mistakes and How to Avoid Them
On Demand
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On Demand
Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
Sponsored by Rottendorf Pharma
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Ensuring Effective Drug Stability Studies
Drug Stability Testing from Development to Shipping
On Demand
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Events
May 23-25, 2016
June 6-8, 2016
June 6-9, 2016
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