Top Stories
The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen.
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FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).
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EXPERT INTERVIEW
Douglas B. Hausner, PhD, from the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) based at Rutgers University, discusses rapid process development for solid-dosage drugs using continuous manufacturing.
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Industry News
Genentech received accelerated approval for its immunotherapy atezolizumab for the treatment of bladder cancer.
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The agency detailed its 2015 achievements in an annual report.
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Supplier News
The company's method reduces the time required to crystallize antibodies from weeks to one day.
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The companies entered into a commercial collaboration to develop web-enabled packaging for pharmaceutical and consumer goods companies.
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Bio/Pharma News
Sanofi announced that it is making several changes to its executive committee, effective June 1, 2016.
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Celgene will pay Agios $200 million to lead exploratory, research, drug discovery, and early development work for metabolic immuno-oncology.
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Natoli Engineering Company's NP-400 tablet press is a 24/7 workhorse that features built-in controls and off-the-shelf electronics. A self-lubricated turret and upper and lower cams reduce maintenance costs and provide longer operation time. The integral controller is encapsulated in a single footprint design that is ideal for tablet manufacturers who need a reliable, efficient press with the ability to produce 180,000 tablets per hour.  Learn more Natoli. |
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MANUFACTURING
Armin Gerhardt, associate professor of Pharmaceutical Science, Concordia University Wisconsin School of Pharmacy, discusses the effects of moisture on product quality and how to achieve good control of moisture during pharmaceutical manufacturing operations.
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HIGHLY POTENT
Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies. Engineering controls are the first line of defense in handling HPAPIs. Engineering controls reduce risk in HPAPI handling.
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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
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SUPPLY CHAIN
With deadlines only a few years away, some companies have not started serialization programs, while others are taking a tactical, short-term approach, losing out on potential business benefits.
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Bio/Pharma in China
New Initiatives, New Opportunities
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Webcasts
On Demand
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
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On Demand
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.Sponsored by Baxter
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Employing a Lean Lab Approach to Optimize Lab Processes:
Part 1: Work Smarter Not Harder
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Events
June 6-8, 2016
June 6-9, 2016
September 12-14, 2016
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REFERENCE BOOKS |
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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eBOOKS
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New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.
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