Cynthia A. Challener

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

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.

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.

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

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 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.

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?

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

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.

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

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

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

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.

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

Adoption of single-use systems and more flexible systems drive innovation.

Greater automation and the adoption of solid versus perforated pans are some recent advances.

The growing demand for targeted biopharmaceutical therapies is driving interest in modular production facilities that can be rapidly constructed while still minimizing risk and cost.

Dynamic testing and advances in shear testing provide better insight into powder physical properties and external variables that affect powder behavior.

New ion-exchange chromatography media are more tolerant of varying conditions, making it possible to eliminate process steps.

Drug manufacturers today are increasingly challenged to find new, effective methods for the delivery of active pharmaceutical ingredients, and many are discovering that orally disintegrating technologies can help.

Advances in monoclonal antibody separation technologies are largely driven by the need to increase efficiencies and reduce cost.

Drug manufacturers today are increasingly challenged to find new, effective methods for the delivery of active pharmaceutical ingredients, and many are discovering that orally disintegrating technologies can help.

New platform technologies and polymer chemistries may facilitate self-administration, longer-term delivery, and targeted delivery of parenteral drugs.

Effective blenders provide efficient, homogeneous mixing and de-aeration for a wide range of formulations

Podcast interview with Nick Johnson, Strategic Marketing Director for Modified Release Technologies at Catalent Pharma Solutions

Results of an American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable survey found that there is real interest in continuous processing and the use of flow chemistry, but hurdles remain.

New capillary-based imaging techniques for protein charge variant analysis are reducing development and start-up times for protein-based therapeutics.

Because peptoids are relatively easy to synthesize, have tremendous sequence diversity, and are more proteolytically stable than peptides and proteins, they have significant potential for use as APIs, drug-delivery agents, and in numerous biomedical applications.

Increasing production efficiency while ensuring high parenteral product quality is the goal of both manual and automated visual inspection systems.

Effective blenders provide efficient, homogeneous mixing and de-aeration for a wide range of formulations.