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Top Stories
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
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Skin-focused company LEO Pharma acquired Bayer's prescription treatment portfolio.
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Industry News
Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.
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Girish Malhotra argues in CPhI Annual Report that shorter approval times and financial incentives are needed to promote manufacturing improvements.
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Supplier News
An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.
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Alcami and the University of North Carolina Wilmington received a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals to prepare students for careers in pharmaceutical sciences.
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Bio/Pharma News
Pfizer Consumer Healthcare is recalling one lot of Children's Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.
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Bristol-Myers Squibb appointed a new executive vice-president and chief commercial officer from within the company, effective immediately.
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Regulatory News
The European Commission (EC) has approved GlaxoSmithKline's (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
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A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.
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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.  Learn More |
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EXCIPIENTS
Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.
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ANALYTICS
Determining how much containment is needed for API handling requires evaluation of multiple factors.
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EQUIPMENT
Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.
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OUTSOURCING
Real-life examples illustrate how to reduce the risks for each transferring partner and ensure that the development process meets regulatory requirements.
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Events
September 24–26, 2018
October 9–11, 2018
October 9–11, 2018
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eBOOKS
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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