Articles by Cynthia Challener, PhD - Pharmaceutical Technology

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Articles by Cynthia Challener, PhD

Regulatory Initiatives Spur API Supply Chain Security

Several recent regulatory initiatives designed to secure the global pharmaceutical supply chain have been implemented or are in the process of being adopted.
Feb 28, 2014

In order to ensure a safe drug supply chain, governments have implemented both legislated and voluntary programs designed to address problem areas.

Demand Increases for Novel Excipients, but Manufacturers Still Face Challenges

Feb 28, 2014

Drug formulators are looking for new excipients to address solubility and bioavailability issues and extend patent protection, but there are hurdles to using novel, specialized ingredients.

Securing the Global API Supply Chain

Several recent regulatory initiatives designed to secure the global pharmaceutical supply chain have been implemented or are in the process of being adopted.
Feb 2, 2014

Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.

Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity

Automated sample handling, advanced glycan analysis and specially designed columns are helping biosimilar manufacturers speed up confirmation of the biosimilarity of their products.
Feb 2, 2014

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

More Rapid Extractable & Leachable Analyses with Advanced Mass Spectrometers

Advances in technology are improving the sensitivity and accuracy of mass spectrometry increasing its use for the analysis of extractables and leachables.
Feb 2, 2014

Advances in technology are improving the sensitivity and accuracy of mass spectrometry, increasing its use for the analysis of extractables and leachables.

Advanced triple quadrupole technology for improved performance and ease of use

Advanced triple quadrupole technology for improved performance and ease of use.
Feb 2, 2014

Advanced triple quadrupole technology for improved performance and ease of use.

Simple and affordable mass detection for the chromatographer

Simple and affordable mass detection for the chromatographer.
Feb 2, 2014

Simple and affordable mass detection for the chromatographer.

Will CMOs Provide Sufficient Capacity for Growing Biologics Demand

Jan 31, 2014

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

The Role of NMR and Mass Spectroscopy in Glycan Analysis

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.
Jan 2, 2014

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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