Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.
Advances in Heterocyclic Chemistry for API Synthesis
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.
Low Temperature Needed for Complex Drug Candidates
The use of low-temperature chemistry can often lead to more direct, cost-effective routes to sophisticated pharmaceutical compounds.
Advances in Fluorination Chemistry for API Synthesis
Safer solid reagents and new coupling chemistry are important developments.
Going Low Temperature
More complex drug candidates require more specialized and selective chemistry.
Excipient Selection for Protein Stabilization
The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.
Accelerating Continuous API Synthesis
Early adopters look to speed up the use of continuous API manufacturing, but lack of expertise hinders adoption of continuous API synthesis.
The Potential of Perfusion
Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
Pursuing Perfusion
Lack of Expertise Hinders Adoption of Continuous API Synthesis
FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.
New Ways Around Hazardous Reagent Chemistry
Safer reagents and reaction conditions are making many hazardous transformations possible.
Advances in Continuous Crystallization
Research groups supported by industry tackle the challenges of continuous crystallization and process analytical technology.
Better Control of the API Supply Chain?
FDA steps up inspections of foreign API manufacturers, thanks to new legislation and changes in policy.
Considering Continuous Crystallization
An integrated pilot plant tests heteronucleation and continuous crystallization.
Specialized Equipment Improves Tableting
Innovations for tablet tooling and presses improve quality and productivity.
FDA Steps Up Foreign Inspections
New legislation and changes in policy at FDA are leading to better control of the API supply chain.
Advances in Tableting
Innovative equipment, analytical techniques, software, and modeling systems are improving the tableting process.
Minimizing Risk during HPAPI Manufacture
Protecting workers, patients, and the environment requires advanced technologies.
Chiral Resolution with and without Resolving Agents
Resolution technologies remain crucial for commercial-scale chiral API production.
Ligand-Binding Assays and the Determination of Biosimilarity
Ligand-binding assays are fundamental to characterizing biosimilars.
Developing and Validating Assays for Small-Molecule Biomarkers
Working with biological matrices and understanding the intended use are crucial.
Dual Sourcing and the Single-Use Supply Chain
API Custom Manufacturing Outlook: More Growth in 2015
Changing dynamics of the pharmaceutical industry are driving demand.
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
FDA Approves Novel Treatments in 2014
FDA approves treatments for new diseases and drugs that operate by new mechanisms.
Novel Technologies Win CPhI Pharma Awards
On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards.
Practical Approaches to Large-Scale Heterocyclic Synthesis
New practical approaches to the synthesis of complex heterocycles are reviewed.
CPhI 2014 Highlights
Selected new technologies, products, and facilities from CPhI Worldwide 2014 are reviewed.
The Challenge of Finding the Unknown
Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.