| PARTICLE ENGINEERING |
Jasdip S. Koner, Eman Z. Dahmash, David A. Wyatt, Afzal Mohammed
Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
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| API SYNTHESIS AND MANUFACTURING |
Cynthia A. Challener
Highly complex APIs developed to treat rare and orphan diseases present big technical questions for contract developers.
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| TOPICAL DRUG FORMULATION |
Jason Carbol, Pia Isabel Tan, Yug Varma, David W. Osborne
Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.
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| QUALITY |
Paula Katz, Tamara Ely, Linda Joy, Jessica Ritsick
Drug manufacturers can improve use of quality agreements in contract manufacturing.
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| ANALYTICS |
Feliza Mirasol
Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.
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| PEER-REVIEWED RESEARCH |
Yurii Pidpruzhnykov, Olena Ruban, Tetiana Kolisnyk
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
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| LAB OPERATIONS |
Amber Lowry
New and emerging products advance bio/pharma laboratory operations.
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| COLD-CHAIN DISTRIBUTION |
Agnes Shanley
Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.
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| FROM THE EDITOR |
Rita C. Peters
FDA enforcement efforts and drug approvals trend upward.
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| OUTSOURCING OUTLOOK |
Ronald A. Rader
Development and adoption of new technologies create challenges that may take years to resolve.
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| REGULATORY WATCH |
Jill Wechsler
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
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| ASK THE EXPERT |
Siegfried Schmitt
In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
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