APIs and Excipients

Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.

Fluorinated molecules play an important role as pharmaceutical compounds. Recent advances seek to overcome the challenges of selective and late-stage insertion of fluorine into small molecules.

Developments involve stereoretentive cross-coupling, enantioselective alcohol silylation, strategies for amplifying signals in circular dichroism spectroscopy, and a synthetic route for the natural product ingenol.

Stapled peptides offer promise to enable cell permeability, binding to therapeutic targets, and modulation of biological pathways.

Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.

The rejection by India's Supreme Court on Novartis' Glivec/Gleevec (imatinib mesylate) and other recent case law raise important issues on patent strategies for solid forms.

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.

Contract API manufacturers proceed with select investment in capacity and service additions.

Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.

As 2012 comes to a close, Pfizer leads among Big Pharma companies for FDA approvals of new molecular entities and biologics.

The promise of antibody drug conjugates is creating a network of partners among large pharma companies and specialized players.

Particle-engineering technologies, such as crystal design for crystallization and producting cocrystals, particle-size reduction, and amorphous solid dispersions, help to optimize delivery of a drug.

Industry and academia advance novel approaches for achieving enanioselectivity.

Approaches to scaling up API syntheses center on ways to optimize process conditions and operability.

Companies roll out expansions in manufacturing high-potency APIs and finished products.

Peptides and related technologies to are starting to improve production.

Targeted polymeric nanoparticles are an important vehicle for controlling and targeting dosing of chemotherapeutic agents.

Advances in palladium-catalyzed hydrogenation, visible-light photocatalysis, and chemocatalyisis for heterocycles are some recent developments.

Excipient manufacturers expand production capacity and partner to broaden their offerings.

Regulatory bodies, standard-setting organizations, and industry seek to tackle the problem of counterfeit drugs and securing the flow of pharma ingredients.

As biopharmaceutical development and commercialization increases, companies are expanding their cold-chain capabilities.

Some recent advances involve strategies for accelerating reaction discovery, approaches for inducing chirality and stereochemical analysis, and applications in nanotechnology for protein elucidation.

Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.

Researchers develop various catalytic approaches for improving yield, purity, stereoselectivity, and process conditions.

The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.

Biocatalysis, chemocatalysis, and other chiral technologies continue to attract the investment dollars of CMOs and fine-chemical companies.

O-arylation and O-alkylation, a one-pot protein synthesis, a combined approach in continued and chemocatalysis, and green-chemistry applications are the target of some recent advances in API synthesis.

The solid form of an API plays a crucial role in drug quality, and advancing methods for screening, detection, and characterization is key.

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

Approaches in using small-molecule and peptide synthesis offer promise in widening the scope of drug candidates.