TRACK AND TRACE

Waking up to Track-and-Trace Benefits

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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PEER-REVIEWED RESEARCH

Developing Cleaning Procedures for Oral Solid-Dose Manufacturing Equipment

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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INSIDE EDQM

Significant Revisions and Updates to the European Pharmacopoeia

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.
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API SYNTHESIS & MANUFACTURING

Upstream and Downstream Operations Can Impact Biologic API Uniformity

Bioprocess operations—from cell line selection to final filtration—can influence the consistency and purity of biologic drug substances.
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DRUG DEVELOPMENT

What is Antibiotic Resistance?

The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.
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TROUBLESHOOTING

Choosing Containment Strategies For Highly Potent APIs

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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OUTSOURCING

Outsourcing of Biomanufacturing in 2016

Growth may be slowing, but outsourcing activity remains healthy.
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ASK THE EXPERT

Reporting Quality Metrics to FDA

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
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EU REGULATORY WATCH

EU on a Mission to Boost R&D

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.
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FROM THE EDITOR

Can Pharma Shake Off that Tainted Image?

Pharma understands the importance of patient centricity, but the problem is the gap between intent and action.
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Webcasts

Optimizing M&A Integration for Customer Success: The CMO Perspective

On Demand
Merger and acquisition (M&A) trends in the contract services and biopharma space are set to continue in the coming years. Although M&A at contract manufacturing organizations (CMOs) can be a stressful time for clients, customers should know that M&As offer various opportunities for continuous improvement and the service providers that go through M&A integration most frequently are likely to be among the best proponents of the process. Learn best practices in approaching integration planning. Find out why change management is vital during acquisitions and learn what you should be communicating during integrations and when you should be talking to the CMO.
Sponsored by AMRI

Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs

On Demand
Poorly-soluble APIs present formulation and development challenges. Excipient selection and manufacturing process development are crucial. Continuous twin-screw granulation is gaining acceptance as a manufacturing technology to address issues presented by these APIs and offers high production capacity in a small footprint. Learn how to improve the solubility of poorly water-soluble active ingredient using twin-screw wet granulation and proper excipients.
Sponsored by BASF