Pharmaceutical Technology-05-02-2014

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.

Mass Spectrometer Enhances Performance in Protein Analysis

Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.

Tony Mitchell of Pharma Tech Industries discusses the handling and packaging of pharmaceutical powders.

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

Zero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers.

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

Aggregation System Improves Analysis of Sub-Visible Particles

With the rising threat of antibiotic resistance and a diminishing R&D pipeline for novel drugs, Europe must step up its game to address this growing problem.

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.

USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.

Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements.

Pharmaceutical Technology spoke with Gloria Gadea-Lopez, associate director of Shire, and Martin Dittmer, PharmaSuite product manager at Rockwell Automation, about how manufacturing execution systems (MES) can improve productivity and the current challenges faced by companies implementing MES systems.

Changes are needed to maintain US biopharma innovation leadership.

Drug developers are taking a wait-and-see approach to the use of cocrystals.

New formulations and expanded vaccine production are encouraged.

Microscope Enables High-Resolution Materials Analysis

The CMO industry's value proposition is limiting its market penetration.

Biopharma companies should not overlook India's growing market.

Laser Diffraction Software Supports Analytical QbD

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