Articles by Cynthia Challener, PhD - Pharmaceutical Technology

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Articles by Cynthia Challener, PhD

Technology Choices in Highly Potent Solid Dosage Manufacturing

Risk management guides decisions in facility design and operation for highly potent drugs.
Jul 2, 2013

Risk management guides decisions in facility design and operation for highly potent drugs.

GE Healthcare, iBio, and Bio-Manguinhos/Fiocruz Advance Large-Scale Plant-Based Protein Production

GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level.
Jul 2, 2013

GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level.

New Chiral Sulfur and Phosphorous Chemistry from Boehringer Ingelheim

New routes enable the efficient synthesis of enantiopure sulfinamides and structurally and sterically diverse P-chiral phosphine oxides.
Jul 2, 2013

New routes enable the efficient synthesis of enantiopure sulfinamides and structurally and sterically diverse P-chiral phosphine oxides.

Addressing Manufacturing Challenges with Nondestructive X-Ray Imaging

Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.
Jul 2, 2013

Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.

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.

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Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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