Cynthia A. Challener

New catalysts show promise for pharmaceutical intermediate and API synthesis.

FDA redefines cocrystals as APIs and not drug-product intermediates.

A simpler, cost-effective method for the preparation of fluorolactams may be suitable for scale-up.

Researchers develop catalysts that mediate complex transformations under conditions appropriate for commercial manufacture.

Drug companies and CDMOs seeking greener routes to the production of complex APIs may look to biocatalysis.

Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.

Recent research of efficient chiral synthesis technologies reveals potential uses in API manufacturing.

Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.

Multiple methods are required for detecting and removing protein impurities.

Research efforts around the world are demonstrating that the application of flow chemistry for small-molecule API synthesis.

Recent chiral advances demonstrate promise for API synthesis.

Effective harvesting and purification processes play an essential role in ensuring that biopharmaceutical manufacturing processes provide biologic drug substances with uniform and consistent properties.

Application of flow chemistry for small-molecule API synthesis continues to expand thanks to research efforts.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

The production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Determining the appropriate amount and type of screening challenges drug developers when identifying relevant crystalline forms.

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.

Scale-down modeling accelerates the development of downstream biopharma manufacturing processes.

Hazardous reagents can prove to be faster, simpler, cheaper, and greener.

Nanoscale catalysts and engineered nanoparticles show promise for API synthesis and delivery.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

Hazardous reagents can simplify processes and provide higher yields and purities.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

Despite fewer FDA approvals in 2015, the prospects for the API market in 2016 are strong.

Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.

A strong API market is expected in 2016 despite fewer new drug approvals.

Multi-component coupling reactions for the generation of heterocycles in fewer steps reduced processing times, cost, and waste are attracting interest.

In the ongoing search for better fluorinating reagents, solid reagents and new coupling reactions are showing promise.