Cynthia A. Challener

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.

Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C–H silylation reactions

Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C-H silylation reactions.

The use of low-temperature chemistry can often lead to more direct, cost-effective routes to sophisticated pharmaceutical compounds.

Safer solid reagents and new coupling chemistry are important developments.

More complex drug candidates require more specialized and selective chemistry.

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.

Early adopters look to speed up the use of continuous API manufacturing, but lack of expertise hinders adoption of continuous API synthesis.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.

Safer reagents and reaction conditions are making many hazardous transformations possible.

Safer reagents and reaction conditions are making many hazardous transformations possible.

Research groups supported by industry tackle the challenges of continuous crystallization and process analytical technology.

FDA steps up inspections of foreign API manufacturers, thanks to new legislation and changes in policy.

An integrated pilot plant tests heteronucleation and continuous crystallization.

Innovations for tablet tooling and presses improve quality and productivity.

New legislation and changes in policy at FDA are leading to better control of the API supply chain.

Innovative equipment, analytical techniques, software, and modeling systems are improving the tableting process.

Protecting workers, patients, and the environment requires advanced technologies.

Resolution technologies remain crucial for commercial-scale chiral API production.

Ligand-binding assays are fundamental to characterizing biosimilars.

Working with biological matrices and understanding the intended use are crucial.