Articles by Cynthia Challener, PhD - Pharmaceutical Technology

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Articles by Cynthia Challener, PhD

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.

Will Aseptic Connectors Make Production Outside of the Cleanroom Possible?

Aseptic connectors provide the flexibility and robustness needed for modern parenteral manufacturing operations.
Jun 12, 2013

Aseptic connectors provide the flexibility and robustness needed for modern parenteral manufacturing operations.

Advancing Softgel Technology for Poorly Soluble or Highly Potent APIs

The lipid-based method provides a tool for delivery of highly potent, poorly soluble, and unstable APIs. And new in-process capsule printing and shell technologies expand softgels applications further.
Jun 12, 2013

The lipid-based method provides a tool for delivery of highly potent, poorly soluble, and unstable APIs. And new in-process capsule printing and shell technologies expand softgels’ applications further.

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Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
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