Development

Articles

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Paragon Bioservices to Scale Up Protein Manufacturing

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

Optimizing Development, Manufacturing, and Technology Transfer in the Outsourced Relationship

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

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

Strategies in API Scale Up

This article focuses on the growing need for effective data management in the life sciences industry-especially among smaller pharmaceutical manufacturers.

Improving Technology Transfer

Jim Greenwood is president and CEO of the Biotechnology Innovation Organization (BIO). He represented Pennsylvania’s 8thÂ district in the US House of Representatives from 1993 to 2005.

Ties between the biotechnology industry and university research are crucial.

Technology Transfer: Protecting the True Public Interest

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

Lyophilization: How to Meet Scale-Up Challenges Using QbD

An understanding of the pan-coating process based on first principles can support successful scale up.

A Practical Guide to Pan Coating and Scale-Up

Abishek Kathuria is technical manager at Evonik Pharma Polymers.

There are various theories about how to scale up a solid dosage coating operation in a pan coater. This article provides a basic process understanding and scale-up theory based on first principles.

Pan Coating and Scale-Up: a Practical Guide Based on First Principles

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Critical issues that should be considered when scaling up a hot-melt extrusion process.

Scale-up Challenges in Hot-Melt Extrusion

With the increasing use of hot-melt extrusion, extruder manufacturers have developed mid-size twin-screw extruders that facilitate process development and scale-up to commercial processes.