Developing and Managing Successful Bio-Outsourcing Relationships

by Clifford S. Mintz, Ph.D.

Published: January, 2006

The bio-outsourcing trend is being influenced by recent developments such as dwindling biopharmaceutical financial support, increasing costs associated with building biomanufacturing facilities, increasing regulatory complexity surrounding biomanufacturing, shortages of qualified manufacturing and technical personnel, and the advent of disposable technologies. All of these topics are covered in detail. The guide will not only serve as a roadmap for achieving best practices in bio-outsourcing relationships but will also serve as a reference source for inexperienced sponsors who need a crash course on developing and managing productive bio-outsourcing relationships.

Overview

D&MD's Developing and Managing Successful Bio-Outsourcing Relationships guide represents the first, concise, easy to follow, one-stop publication that answers all of the seminal questions necessary to create and effectively manage bio-outsourcing relationships. Individuals who read the guide and follow its suggestions should be well on their way to establishing long lasting and productive bio-outsourcing relationships. The guide outlines the essential ingredients that must be included in any successful bio-outsourcing relationship between sponsors and contract manufacturers. It also includes a directory of current contract biomanufacturing companies and providers.

Receive answers to key questions such as:

> Why do companies outsource biomanufacturing?

> How does a company determine whether outsourcing is right for them?

> What legal, business, and financial issues need to be considered before entering into a bio-outsourcing relationship?

> What are best practices for managing an effective bio-outsourcing relationship?

> What are the future trends for the bio-outsourcing industry?

Market Opportunities

> Emergence of disposable technologies industry, e.g. new bioreactors, purification equipment, plastic storage containers, new culture media etc. to support the emerging bio-outsourcing industry

> Increasing numbers of companies that specialize in the design, construction of both stainless steel and disposable manufacturing facilities

> Growth of the CBMO industry in Asia, India, Latin America and South America, a source of skilled and inexpensive labor

> Companies that specialize in biomanufacturing and regulatory compliance training (conventional and e-based) will emerge to support the personnel needs of the burgeoning CBMO industry

Chapter Summary

1 What is Bio-Outsourcing?

2 Is Bio-Outsourcing Right For Your Company?

3 Finding and Choosing the "Right" CBMO

Factors to Consider

The Selection Process

4 Getting Started: Negotiating and Crafting the Quality Agreement

5 Best Practice for Bio-Outsourcing Relationships

Overview

Process Management

Ensuring Successful Technology Transfer

Who is Responsible When Things Go Wrong?

Training Personnel

Organization

Governance and Relationship Management

Project Teams

Man in the Plant

Performance

Importance of Metrics

Quality Systems and Ensuring Regulatory Compliance

Information Systems

6 Future of Bio-Outsourcing: Impact of New Technologies and Emerging Markets

7 CBMO Directories

Format: Printed
Table of Contents
Price: $795.00 / GBP397.50