Pharmaceutical Technology
February 06, 2020
Outsourcing
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2
Quick approval pathways challenge teams to balance compliance with the need for speed.
February 02, 2020
Regulatory Watch
44
2
Increased reliance on foreign producers raises concerns and spurs collaborations.
February 02, 2020
From the Editor
44
2
Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.
February 02, 2020
Ask the Expert
44
2
ICH 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.
February 02, 2020
Regulatory Watch
44
2
The UK and Europe are entering a transitional period, which will involve negotiations across the board, including those on the pharma regulatory landscape.
February 02, 2020
From the Editor
44
2
Amid the rapidly rising cases of a novel coronavirus, concerns are being raised over preparedness and potential disruptions to the pharma supply chain.
February 02, 2020
Operations
44
2
Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.
February 02, 2020
Manufacturing
44
2
Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.
February 02, 2020
Quality/Regulations
44
2
Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase.
February 02, 2020
Product Spotlight
44
2
The Eagle-Omni blister machine from Maruho Hatsujyo Innovations can be used for packaging development, materials testing and production, and forming, sealing, and punching operations at sequential stations.
February 02, 2020
Product Spotlight
44
2
The Ross VMC-1000 VersaMix is a 1000-gallon triple-shaft mixer available on a pivot-design single-post hydraulic lift.
February 02, 2020
Product Spotlight
44
2
Werum IT Solutions launched the new K.ME-IN in January 2020, a biometric authentication solution with a wearable Nymi Band device, for its PAS-X Manufacturing Execution System.
February 02, 2020
Product Spotlight
44
2
The Pharmafill NB1, Series II from Deitz is an automated neck bander that can accommodate shrinkbands and full sleeve labels from .79–10 inches in length.
February 02, 2020
Manufacturing
44
2
Consider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.
February 02, 2020
Formulation
44
2
Lipid-based solutions offer a natural approach to improving the solubility of cannabinoid-derived products.
February 02, 2020
Formulation
44
2
Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.
February 02, 2020
Cover Story
44
2
Analytical solutions are improving for raw material testing, drug product release process development, and more.
February 02, 2020
Analytics
44
2
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.
February 02, 2020
Peer-Reviewed Research
44
2
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.
February 02, 2020
Operations
44
2
Vein-to-vein programs are focusing on data access and traceability.
February 02, 2020
Issue PDF
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Click the title above to open the Pharmaceutical Technology February 2020 issue in an interactive PDF format.