Pharmaceutical Technology-11-02-2013

New regulation offers patients in Brazil greater access to experimental drugs.

Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.

Predicting long-term storage stability of a given protein and formulation is desirable for effective screening and optimization early in the development process. Multiple routes to aggregation during storage to suggest that multiple measurement types should be made to probe different aspects of protein behavior.

The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.

Automation System Improves Operational Insight

Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

The benefits of solvent-free processes and techniques specifically optimized for coating new dosage forms such as orally disintegrating granules are reviewed.

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

Pharmaceutical companies are using formulation strategies as a lifecycle management tool to maximize product value and preserve their revenue streams.

Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.

Pharmaceutical companies have long recognized the need to protect their market position long before their products come off patent. Pharmaceutical Technology spoke to Neal Hansen, managing director of the consulting firm, Hansen Strategy, about key considerations in product lifecycle management

Wireless Network Monitors Air Cooled Heat Exchanger

Database Improves Process Efficiency

System Links Packaging Operations

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.

The JOBS Act and FDASIA show early signs of accelerating drug development.

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