Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Frontrunners in Bispecific Antibodies

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Articles

Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more...

Week of Nov. 16, 2009: GSK and Nabi Form Nicotine Vaccine Agreement; Eli Lilly Research Exec to Retire; More...

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

A consortium led by GlaxoSmithKline (UK) intends to deliver a "step change improvement" in pharmaceutical tablet manufacturing in the UK by "substantially" increasing the country's manufacturing efficiency.

UK Backs Continuous Processing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Novartis reported that German regulatory authorities approved its adjuvanted cell culture-based Influenza A (H1N1) 2009 monovalent vaccine, Celtura. The company also said it will acquire a stake in Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical.

Novartis Updates Vaccine Progress in Germany; Acquires Chinese Vaccine Manufacturer

The European Medicines Agency, the European Center for Disease Prevention and Control, and the Heads of Medicines Agencies issued a European strategy for H1N1 vaccine benefit–risk monitoring.

EU Issues Strategy for Influenza A (H1N1) Vaccine Benefit–Risk Monitoring

Leading experts from an upcoming conference on biosimilars by the Drug, Chemical, and Associated Technologies Association share their insights on the manufacturing and regulatory considerations for biosimilars.

Manufacturing and Regulatory Considerations in Biosimilars

A smart nanocage that can be filled with a medicinal substance and then activated using light has been developed by US researchers.

Light-activated gold cage delivery capsule developed

The European Organisation for Rare Diseases (EURORDIS) has predicted that 100 new designated orphan products will receive marketing authorization between 2009 and 2019, which equates to approximately 10 new products every year.

10 new orphan products a year between 2009 and 2019

Dave Abram is manager of validation and technical services at BioConvergence LLC, 4320 West Zenith Drive, Bloomington, IN 47404, tel. 812.961.1700, fax 812.961.1733.

The author details the factors in formulation design, requirements in facilites and equipment, and validation criteria for aseptic formualtions.

Current Perspectives on Aseptic Formulations

The author discusses the risks involved with aseptic processing, methods and tools used to identify and control risk, and regulatory guidelines relevant to the risk-management process.

Risk Management for Aseptic Processing

Mark Copley discusses the methods used for DPI testing and the challenges presented by the current regulatory framework.