Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.
PAT Developments Move Continuous API Manufacturing Ahead
Advances in equipment, instrument, and control systems are enabling online monitoring of continuous API manufacturing.
Catalysis, Flow Chemistry Impact API Manufacturing
Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
Seeking Solutions for Oral Delivery of Biologic APIs
Researchers continue efforts to overcome challenges of effective oral delivery of biologic drugs.
PAT for Continuous API Manufacturing Progresses
Advances in process analytical technology have been achieved, but significant challenges remain.
Oral Delivery of Biologic APIs: The Challenge Continues
Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.
Standards Set Excipient GMPs, But Collaboration is Needed
Meeting evolving global requirements for excipients requires close collaboration between pharmaceutical companies and excipient suppliers.
Mass Spectrometry Measures Up to Biologics Drug Analytical Challenges
Mass spectrometry plays and important role in advancing on biologic drug development and manufacturing, but limitations still exist.
Collaboration Key to Meeting Excipient GMP Requirements
Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.
Mass Spec Sheds New Light on Biologics Drug Development
Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
New Drug Approvals Slump in 2016
FDA issued approvals for less than half the number of new drugs in 2016 compared with 2015.
New Catalysts Enable Cross-Coupling Reactions
Alternatives to expensive palladium catalysts are gaining acceptance for commercial API synthesis.
FDA New Drug Approvals Down Significantly in 2016
As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.
New Opportunities for Cocrystals
Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.
New Horizons for Cross-Coupling Reactions
Non-precious-metal catalysts are increasingly employed for commercial API synthesis.
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing models.
Cost-Effective Catalysts Could Replace Traditional Multi-Step Processes
New catalysts show promise for pharmaceutical intermediate and API synthesis.
“Rebirth” of Cocrystals?
FDA redefines cocrystals as APIs and not drug-product intermediates.
Researchers Identify a Greener Fluorination Reaction
A simpler, cost-effective method for the preparation of fluorolactams may be suitable for scale-up.
The Search for Practical and Economical Catalysts
Researchers develop catalysts that mediate complex transformations under conditions appropriate for commercial manufacture.
The Enzymatic Catalysis Route to Going Green
Drug companies and CDMOs seeking greener routes to the production of complex APIs may look to biocatalysis.
The Search for a Greener Fluorination Reaction
Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.
Chiral Advances Demonstrate Promise for API Synthesis
Recent research of efficient chiral synthesis technologies reveals potential uses in API manufacturing.
Going Green with Biocatalysis
Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.
Protein Impurities Pose Challenges
Multiple methods are required for detecting and removing protein impurities.
Flow Chemistry Discoveries Advance Continuous Processing
Research efforts around the world are demonstrating that the application of flow chemistry for small-molecule API synthesis.
Expanding the Chiral Toolbox
Recent chiral advances demonstrate promise for API synthesis.
Ensuring Biologic API Uniformity
Effective harvesting and purification processes play an essential role in ensuring that biopharmaceutical manufacturing processes provide biologic drug substances with uniform and consistent properties.
Steps Closer to the Adoption of Continuous Processing
Application of flow chemistry for small-molecule API synthesis continues to expand thanks to research efforts.
Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing
ADCs Challenge Manufacturers’ Skill Sets
The production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.