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Top Stories
Faced with unprecedented flooding from Hurricane Harvey and days of persistent rain, Arkema's Crosby, TX, plant lost all power, causing flammable chemicals to ignite.
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FDA approves Novartis' CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.
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TOP COUNTRY FOR PHARMA?
What Country Ranks Highest in Pharma Manufacturing?
CPhI survey seeks industry input to rank top-performing nations on pharma manufacturing and business factors.
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Industry News
Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.
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FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.
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Connect Upstream for Quality by Design
Quickly establish your design space with our ambr® 250 mini bioreactors. Easily scale up to BIOSTAT STR® bioreactors with our new scale conversion tool. Simplify data analysis and knowledge management across scales with our MFCS SCADA system and integrated Umetrics software suite for design of experiments (DoE) and multivariate data analysis (MVDA).
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Supplier News
Thermo Fisher Scientific has completed the previously announced acquisition of Patheon for approximately $7.2 billion.
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MilliporeSigma announced a collaboration with Angiex, a biotechnology start-up, to support the development of Angiex's lead oncology antibody drug candidate to clinical use.
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Bio/Pharma News
FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company's new drug application for its investigational Parkinson's disease drug.
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Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.
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Regulatory News
Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.
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A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.
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Quality
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
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Viewpoints
Amid contentious debate about "fake news," peer-review papers offer vital, objective insight.
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Manufacturing
Everyone from IT departments through to manufacturing line personnel should be aware of cybersecurity threats and how to prevent attacks.
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Supply Chain
The contract development and manufacturing organization (CDMO) Aesica Pharmaceuticals has had a serialization program in place for the past five years, and recently installed capabilities for serialization at all its packaging facilities.
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Events
September 11–13, 2017
September 19–21, 2017
September 25–29, 2017
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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