Top Stories
Patheon launches initial public offering to repay outstanding notes and expenses.
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FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency.
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EAG Laboratories announces new company identity and intent to expand testing, analysis, and characterization capabilities across multiple markets.
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Industry News
Cancer cell lines could provide viable pathways to determining how tumors respond to specific anti-cancer drugs.
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A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.
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EXPERT INTERVIEW
Angelo Stracquatanio, co-founder of Apprentice Field Suite, spoke with Pharmaceutical Technology about smart glasses and their use in pharmaceutical manufacturing.
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Natoli Engineering is more than simply tablet compression tooling. We provide a series of critical services for the tablet compression industry. Natoli Scientific can assess and resolve your most pervasive formulation issues. Natoli Metallurgy can help improve the longevity of your tooling, analyze material chemistry and coatings, and help troubleshoot tool failure.
 Learn more about all of Natoli's Services today! |
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Supplier News
UPS will expand its clinical trial logistics capabilities to include drug and vaccine development.
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The company will invest €100 million in the expansion of its Athlone facility.
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Bio/Pharma News
The company will collaborate with the Walter Reed Army Institute of Research to co-develop a Zika vaccine candidate.
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Teligent is expanding its manufacturing and R&D complex in New Jersey.
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A Guide to Applying the Four Pillars of ICH Q10
With the FDA cracking down on oversight and the resulting increase in regulations, there is a rising need for initiatives that provide guidance to help enhance the scope of safety and quality within the Pharmaceuticals industry.
In this white paper learn about the four pillars of ICH Q10 and how to apply them within your organization
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Regulatory News
The agency announced that it has completed the review of the GDUFA backlog one year ahead of schedule.
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The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.
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The Advantages of a Employing a Lipid-Based Formulation Process in Early Development
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FORMULATION
Polymers have played a key role as solubilizing excipients. Industry experts explain why polymer structures and functionalities are important considerations in formulation development.
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DRUG DEVELOPMENT
Lipid-based drug delivery is increasingly being used to tackle oral bioavailability challenges resulting from poor solubility.
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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
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PEER-REVIEWED RESEARCH
The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.
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MANUFACTURING
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
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Bio/Pharma in China
New Initiatives, New Opportunities
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Webcasts
On Demand
In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.
Sponsored by SGS Life Science Services |
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On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
Sponsored by Capsugel
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Events
August 10-11, 2016
August 17-18, 2016
September 12-14, 2016
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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to 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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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems. |
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