Articles by Cynthia Challener, PhD - Pharmaceutical Technology

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Articles by Cynthia Challener, PhD

Experts from Novo Nordisk, Baxter Discuss Technological Advances in Addressing the Challenge of Extractables and Leachables

Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs.
Jul 2, 2013

Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs.

Track-and-Trace Compliance Looming, but Once Implemented Will It Bring Benefits?

Serialization regulations in California and the EU come into effect in 2015 and 2016, and two US federal bills are moving through Congress. What are the implications for the pharmaceutical industry?
Jun 26, 2013

Serialization regulations in California and the EU come into effect in 2015 and 2016, and two US federal bills are moving through Congress. What are the implications for the pharmaceutical industry?

Fujifilm Diosynth Biotechnologies in an Expansion Mode

Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.
Jun 26, 2013

Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.

Cocrystals Can Improve API Properties, But Will the Recent FDA Guidance Slow Adoption of This Technology?

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.
Jun 26, 2013

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

Aseptic Filling is the Next-Generation Application for Single-Use Systems

The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.
Jun 26, 2013

The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.

New High-Throughput Glycan Analysis Improving Cell-Line Selection and Early Bioprocess Development

Until recently, glycan analysis has been a slow, labor-intensive process more widely used late in bioprocess development. New high-throughput methods are changing that.
Jun 26, 2013

Until recently, glycan analysis has been a slow, labor-intensive process more widely used late in bioprocess development. New high-throughput methods are changing that.

Rising Interest in Terahertz Spectroscopy in Pharmaceutical Analysis

Now at a practical size and price, terahertz spectroscopy is advancing as a nondestructive method of analysis for solid forms and tablet coatings.
Jun 12, 2013

Now at a practical size and price, terahertz spectroscopy is advancing as a nondestructive method of analysis for solid forms and tablet coatings.

Mimicking Nature with the Click of a Reaction

Click chemistry has become a powerful tool in drug discovery, chemical biology, and proteomic applications.
Jun 12, 2013

Click chemistry has become a powerful tool in drug discovery, chemical biology, and proteomic applications.

Single-Use Systems and Chromatography Purification Techniques Improve Conjugate Vaccine Manufacturing

Conjugated vaccines are meeting the need for longer-lasting immune responses, but the production process is complex, and manufacturers are looking for simpler solutions.
Jun 12, 2013

Conjugated vaccines are meeting the need for longer-lasting immune responses, but the production process is complex, and manufacturers are looking for simpler solutions.

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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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