April 2018
Volume 30, No. 4 |
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| COVER STORY |
Jennifer Markarian
The pharmaceutical industry is adopting Industry 4.0 and emerging technologies to improve product quality and manufacturing efficiency.
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| API SYNTHESIS AND MANUFACTURING |
Cynthia A. Challener
CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.
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| FORMULATION |
Adeline Siew, PhD
The high viscosity of highly concentrated monoclonal antibody formulations not only presents processing and storage difficulties, but also formulation and delivery challenges.
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| MANUFACTURING |
Jennifer Markarian
Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.
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| PEER-REVIEWED RESEARCH |
Nicole Steiner-Reischütz, Michael Pyerin, Chrysoula Kanakaki, Daniela Neubert, Michael Washüttl, Michael Krainz
Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
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| ANALYTICS |
Cynthia A. Challener
Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.
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| CERTIFICATES OF ANALYSIS |
Agnes Shanley
Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.
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| OUTSOURCING |
Stephen Tindal, Ronak Savla
Formulation expertise can smooth the transition of a prospective therapy from medicinal chemistry to drug dosage form.
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| QUALITY |
Kevin Stembridge, Michalle Adkins
Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
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| EU REGULATORY WATCH |
Sean Milmo
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.
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| ASK THE EXPERT |
Susan J. Schniepp
Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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| EVENTS |
Coventry, UK
24–25 April 2018
Frankfurt am Main, Germany
11–15 June 2018
more events
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