APIs and Excipients

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

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

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

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

Boehringer Ingelheim has entered into a non-exclusive technology and commercial license option agreement with BaroFold. Under the terms of the agreement, Boehringer Ingelheim will license BaroFold's pressure-enabled manufacturing technology (PreEMT).

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.

Solubilizers play an important role in dissolving poorly soluble molecules. As the number of poorly soluble lipophilic and/or hydrophobic molecules increases-whether as "brick dusts" or waxy substances-the industry is struggling to identify the appropriate lipophilic excipients (surfactants, solubilizers, solvents or polymers) that can be used to develop such poorly soluble formulations into solid dosages and other forms of pharmaceutical products.

Industry and academia advance novel approaches for achieving enanioselectivity.

USP optimizes identification tests and impurities procedures.

A Q&A with BASF moderated by Patricia Van Arnum.

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.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

A complete and unedited audio slideshow of the Excipient Fest roundtable on atypical visible particles

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.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2012 edition from EMD Millipore and Meissner Filtration Products.

Peptides and related technologies to are starting to improve production.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

Industry wants more innovation, but can suppliers meet customer needs?

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.

In this technical forum, experts describe different methods of rapid microbial testing and their applications.

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

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