Designing Clean Zones

Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.
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FORMULATION

Developing an Orally Inhaled Dry Powder Formulation—A Complex Itinerary and a Technological Challenge

Successful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance.
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PEER-REVIEWED RESEARCH

Using a Dual-Drug Resinate Complex for Taste Masking

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.
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API SYNTHESIS & MANUFACTURING

New Ways Around Hazardous Reagent Chemistry

Safer reagents and reaction conditions are making many hazardous transformations possible.
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TROUBLESHOOTING

Preventing Common Mistakes in Automated Washing

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.
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OUTSOURCING REVIEW

Another In-House Operation Gets Outsourced

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.
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REGULATORY WATCH

EU’s New Post-Authorization Variations Framework Comes Under Scrutiny

The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.
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Webcasts

Controlling the Physical Properties and Performance of Semi-solid Formulations Through Excipient Selection

Wednesday, June 10, 2015 at 11 am ET
BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.
Sponsored by: BASF

Sample Preparation Technologies for Improved Peptide Quantitation Workflow

Tuesday, June 16, 2015 at 11 am EDT | 8 am PDT | 16:00 BST | 17:00 CEST
Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.
Sponsored by: Thermo Fisher Scientific

Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments

Wednesday, June 17, 2015, 2 pm EDT | 11 am PDT
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by: Tosoh Bioscience LLC