Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

An industry roundtable representing Metrics, Cambrex, Carbogen Amcis, Euticals, Ferro Pfanstiehl, and SAFC.

Strategies for High-Containment

The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms and APIs of generic drugs.

Moving to Risk-Based Inspections

The author discusses strategies for preventing cargo theft.

Pharmaceutical-Based Cargo Security and Theft Prevention

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

Scaling up API Syntheses

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.

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

Gauging Biopharm Outsourcing

Enhancing bioavailability can be achieved through hot-melt extrusion or spray drying. Patricia Van Arnum interviews Bend Research to find out more about when to use each technique.

Bioavailability Enhancement: When to Use Hot-Melt Extrusion versus Spray Drying

The manufacturing capacity-sharing model in biologics and Merck & Co. and MedImmune ushers in a new paradigm of "co-opetition".

A Manufacturing Capacity-Sharing Model: Merck & Co. and MedImmune LLC

An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.

Market Strengths and Weaknesses in Biosimilars

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

What is Ahead in Chemical API Manufacturing

Holistic open learning networks offer a new drug R&D model for improving research outcomes.

Ingredients