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Felicity Thomas
Lipid-based solutions offer a natural approach to improving the solubility of cannabinoid-derived products.
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| MANUFACTURING |
Isaiah Cedillo, Bill Jarvis, Tony Pavone
Consider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.
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Tim Roach
Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.
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| PEER-REVIEWED RESEARCH |
Donald A. Johnson, PhD, RAC
This paper discusses what causes cross-linking, how cross-linking is addressed with addition of enzymes, and consideration for occasional high results that can be obtained during release testing.
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| ANALYTICS |
Aaron O. Bailey
Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.
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| QUALITY/REGULATIONS |
Lauren Lavelle
Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase
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| OPERATIONS |
Jennifer Markarian
Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products
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Agnes Shanley
Vein-to-vein programs are focusing on data access and traceability.
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| OUTSOURCING |
Agnes Shanley
Quick approval pathways challenge teams to balance compliance with the need for speed.
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| FROM THE EDITOR |
Rita C. Peters
Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.
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| US REGULATORY WATCH |
Jill Wechsler
Increased reliance on foreign producers raises concerns and spurs collaborations.
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| ASK THE EXPERT |
Susan J. Schniepp
CH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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