API Synthesis and Manufacturing, Small Molecule

Access to extremely low and consistently controlled reaction temperatures can improve product yields and selectivities while also reducing costs.

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.

Access to simpler and more direct methodologies for the incorporation of fluorinated substituents remains an unmet need in pharmaceutical synthesis. An analysis of recent trends in fluorination chemistry.

Continuous flow chemistry offers potential for greater control, improved safety and environmental profiles, and efficient chemical transformations.

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

Visual mapping can provide a particle-size distribution estimate.

As contract API manufacturers, fine-chemical producers, and pharmaceutical companies prepare to attend Informex in Anaheim this month, the state of the industry shows improving conditions in certain sectors.

Siegfried Schmitt, a principal consultant with PAREXEL, discusses how the EU's Falsified Medicines Directive will affect US API production.

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.

Recent research on elucidating the structure and sequence of proteins involves examining the effect of microgravity on protein crystallization and a computational model for protein elucidation.

The authors examine the use of various grades of direct-compression mannitol in direct-compression tableting process to evaluate the content uniformity of micronized APIs and excipients in a solid-dosage formulation.

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.

The authors explain chemical transformations that are achievable through certain biocatalytic routes.

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

Flow chemistry and microreactors offer an alternative to traditional batch manufacturing.

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

Flow chemistry and microreactors offer alternatives to traditional batch manufacturing.

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.

Contract API manufacturers and fine-chemical producers roll out capacity and service expansions.

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.

Nanosized systems are important in drug delivery. Such nanosized systems include liposomes, nanocrystals, micelles, colloidal particles, quantum dots, and dendrimers. Dendrimers are class of synthetic macromolecules with highly branched, monodispersed, circular, and symmetrical architecture that are used as carrier molecules in drug delivery.

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.