September 2015
Volume 39, No. 9 |
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|Focus|
Susan Haigney
QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.
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|SPECIAL ISSUE|
Be sure to check out this month’s APIs, Excipients, and Manufacturing special issue for articles on excipient selection, import testing, PAT, FDA inspections, and cleaning validation, plus a preview of CPhI Worldwide.
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|PEER-REVIEW RESEARCH|
Andrew Teasdale, Katherine Ulman, Jean Domoradzki, Phyllis Walsh
Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting; available information shows that exposure to low-level elemental impurities is unlikely to be a substantive concern for topical drug products.
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PharmTech September Issue
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|REGULATORY WATCH|
Sean Milmo
EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.
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Jill Wechsler
Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
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Kristina Adams, Xiaochuan Yang, Min Li, Thomas O'Connor, Lane Christensen, Frank Holcombe Jr., Andre Raw, Susan Rosencrance, Geoffrey Wu
An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Lisa Tung, Maria Eng
A study of recent inspection observations allows for baseline trending and continuous improvement.
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|FORMULATION|
Adeline Siew, PhD
Experts spoke to Pharmaceutical Technology Europe about the different approaches used in taste-masking and the challenges involved.
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|EXCIPIENTS|
Cynthia A. Challener
The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.
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|FACILITY DESIGN|
Susan Haigney
The industry is moving towards more flexible manufacturing with the use of modular facilities and single-use systems.
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Eric Bohn
Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.
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|API SYNTHESIS & MANUFACTURING|
Cynthia A. Challener
More complex drug candidates require more specialized and selective chemistry.
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|OUTSOURCING REVIEW|
Eric Langer
Suppliers indicate prices for single-use equipment are likely to increase.
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|TROUBLESHOOTING|
Jennifer Markarian
Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile pharmaceutical manufacturing process, including vial filling; operators share best practices for cleaning.
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|ASK THE EXPERT|
Siegfried Schmitt
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.
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|Webcasts|
Poorly-soluble APIs present formulation and development challenges. Excipient selection and manufacturing process development are crucial. Continuous twin-screw granulation is gaining acceptance as a manufacturing technology to address issues presented by these APIs and offers high production capacity in a small footprint. Learn how to improve the solubility of poorly water-soluble active ingredient using twin-screw wet granulation and proper excipients.
Sponsored by BASF
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience
more webcasts
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|on pharmtech tv|
Blow-Fill-Seal for Aseptic Processes
The Human Element in Pharma Manufacturing
Working with CMOs and CDMOs
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|Events|
September 28–30, 2015 | Washington, DC, USA
October 6–8, 2015 | Hannover, Germany
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