Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

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

Fine-Chemical Producers Make Targeted Investments

Shireesh P. Apte, PhD, is a lead scientist at Baxter I.V. Systems Inc.

This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.

Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards

A Q&A with Tony Hitchcock, head of manufacturing at Cobra Biologics.

Viral Vaccine Manufacturing

The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas.

IPEC Releases Revised Excipient Information Package Guidance

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

Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in-vitro cell culture matrices that can offer physiological microenvironments for living cells.

Roche and BioLamina Collaborate on Novel Cell Culture Systems

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

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

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Specially designed excipients, improvements in processing capabilities, and a growing understanding of the hot-melt extrusion (HME) process is increasing the use of HME as an approach for enhancing the bioavailability of poorly soluble drugs.

APIs and Excipients