Manufacturing

Articles

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.

TxCell Launches Industrialization Laboratories and Technology Transfer Academy

Cambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an opportunity to drive sustainable growth. Conclusions from the workshop are presented in this article.

Emerging Markets—An Opportunity for Pharma to Drive Sustainable Growth

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

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

The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.

Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Eli Lilly and GlaxoSmithKline are among several pharmaceutical companies using technology transfer as way to improve health outcomes in the developing world.

Technology Transfer in Global Health Initiatives

The authors highlight the need for a technology-transfer process that is efficient, cost-effective, and repeatable, stressing the importance of process understanding. Read this and other preferred organization articles in this special issue.

Keys to Executing a Successful Technology Transfer

Miron Ludzinski is a senior research scientist at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company.

Madhav Kamat, PhD, RPh, is a senior principal scientist at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08993.

Amol Mungikar, PhD, is a research investigator at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company.

The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.

Evaluating Functional Equivalency as a Lyophilization Cycle Transfer Tool

A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.