June 2015
Volume 39, No. 6 |
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|Focus|
Randi Hernandez
Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.
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|Featured content|
Adeline Siew, PhD
PAT holds the key to real-time quality assurance and consistent product quality in pharmaceutical manufacturing.
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Eric Bohn
Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.
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PharmTech June Issue
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|PEER-REVIEWED RESEARCH|
Jyoti Mundlia, Rakesh Kumar Marwaha, and Harish Dureja
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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|FORMULATION|
Gonçalo Andrade
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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|API SYNTHESIS & MANUFACTURING|
Cynthia A. Challener
Safer reagents and reaction conditions are making many hazardous transformations possible.
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|TROUBLESHOOTING|
Olivier Van Houtte
Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.
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|OUTSOURCING OUTLOOK|
Eric S. Langer
Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.
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|REGULATORY WATCH |
Jill Wechsler
Regulators and industry seek to streamline and harmonize oversight of postapproval changes.
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Sean Milmo
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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|OTHER FEATURES |
Stephen Wicks, PhD
Will biosimilars share a compendial identity like generic drugs do?
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Rita Peters
Peer-reviewed papers and technical articles can help advance bio/pharmaceutical development.
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Pharmaceutical Technology spoke with David Fitzhenry about the costs of specialty drugs.
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|Webcasts|
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
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
more webcasts
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|on pharmtech tv|
Focus on Biobetters, Part 1
Feeding Powders in Pharmaceutical Processes
Reducing the Cost of Drug Manufacturing
FDA Applications and New Guidance Documents
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|Events|
June 15-18, 2015 | Philadelphia, PA
June 23–24, 2015 | Bethesda, MD
June 23–25, 2015 | Boston, MA
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