Drug Development

Articles

FDA's requirements for API manufacturers in regards to ICH Q7.

Adhering to ICH Q7 for GMPs

Visual mapping can provide a particle-size distribution estimate.

Measuring API Particle Size Distribution

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.

Outsourcing Nontraditional Protein Expression Systems

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Pharmaceutical Technology brought together a panel of industry experts for a special forum to discuss solubilizing polymers and the related formulation strategies for poorly soluble drugs.

Advancing Polymers for Solubility Enhancement

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.

Quality by Design in Excipients

The use of various documents and guides by the International Pharmaceutical Excipients Council can facilitate the flow of information among excipient manufacturers, distributors, and users.

Standardizing Excipient Information to Achieve Supply-Chain Security

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.

Cautious Times for Fine-Chemical Producers and Contract API Manufacturers

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

The EU's Falsified Medicines Directive and APIs

Researchers use inorganic catalysts as an alternative to biocatalysts in the selective conversion of sugars to produce chiral building blocks.

Gaining Stereoselectivity in Asymmetric Synthesis

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

Ingredients