| RAW MATERIALS|
Agnes Shanley
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
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| ANALYTICAL QUALITY BY DESIGN |
Mark Argentine, Kimber Barnett, Marion Chatfield, Elizabeth Hewitt, Patrick Jackson, Shreekant Karmarkar, Ariane Marolewski, Andrea M. Pless, Andy Rignall, David Semin, Mark D. Trone, Qinggang Wang, Zeena Williams, Yanqun Zhao
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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| PROCESS HEATING |
Martin Haagen
Renewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
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| TROUBLESHOOTING|
Jennifer Markarian
The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.
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| CALORIMETRY |
Simon Gaisford
Interpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.
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| QUALITY |
Susan Haigney
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
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| PARTICLE CHARACTERIZATION |
Cathryn Langley
MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.
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| MANUFACTURING|
The transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.
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| API SYNTHESIS AND MANUFACTURING |
Cynthia A. Challener
Advances in process analytical technology have been achieved, but significant challenges remain.
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| REGULATORY WATCH |
Jill Wechsler
Industry fears limited benefits as FDA readies voluntary data tracking program.
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| OUTSOURCING OUTLOOK |
Vicky Qing XIA
New study shows China biopharma companies face staffing shortages.
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| ASK THE EXPERT |
Susan J. Schniepp
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
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| FROM THE EDITOR |
Rita C. Peters
Philadelphia plays host to CPhI North America on May 16-18, 2017.
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| PRODUCT SPOTLIGHT |
The VersaMix Multi-Shaft Mixer, from Ross, Charles & Son, is used to mix pastes, creams, and gel-type products.
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The Thinky PR-1 Nanoparticle Dispersion Machine from Intertronics is a desktop unit that can disperse carbon nanotubes (CNT), graphene, and other 2D nanomaterials within a closed container.
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The Cannabis Analyzer for Potency from Shimadzu Scientific Instruments (SSI) is a high-performance liquid chromatograph (HPLC) specifically for quantitative determination of cannabinoid content.
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The X500B QTOF System is the latest solution in SCIEX's X-Series Quadrupole Time of Flight (QTOF) mass spectrometry (MS) platform.
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