COLD CHAIN

Cold Chain: Going the Extra Mile

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.
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OUTSOURCING

Macro Matters

Heightened global uncertainty could slow bio/pharma development activity.
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PEER-REVIEWED RESEARCH

Error Assessment of Drug Concentration in Multicomponent Pharmaceutical Mixtures

A novel method, based on differential calculus, was used to calculate the maximum potential error associated with the drug concentration in pharmaceutical mixtures composed of an infinite number of ingredients measured on an infinite number of balances with different sensitivities. The method was further applied to calculate the ingredients’ least allowable quantities. This approach ensures that the pharmaceutical formulation is prepared within a given maximum permissible error in drug dose.
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EUROPEAN REGULATORY WATCH

EMA Outlines Network Strategy for Next Five Years

The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.
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US REGULATORY WATCH

Innovative Therapies Require Modern Manufacturing Systems

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
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API SYNTHESIS AND MANUFACTURING

Faster, Cheaper, and Greener

Hazardous reagents can simplify processes and provide higher yields and purities.
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TROUBLESHOOTING

Preventing Film Coating Problems by Design

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.
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STATISTICAL SOLUTIONS

Measurement Uncertainty without the Math

Performing a measurement uncertainty calculation is often seen as problematic.
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ASK THE EXPERT

Creating Robust CAPA Systems

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.
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VIEWPOINT

Innovating for Innovation

Suppliers must develop new technologies to drive the bio/pharma innovation engine.
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Webcasts

Comparing Performance of Gelatin Capsules and the Next Generation of HPMC Capsules

On Demand
New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules and early research into HPMC’s role as a functional excipient.
Sponsored by Capsugel

Best Practices for Effective Product Transfer

On Demand
Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
Sponsored by Rottendorf Pharma