Introduction and Acknowledgements

Welcome to BioPharm International's Guide to Formulation, Fill, and Finish, focused on pharmaceuticals — mainly proteins — produced by biologic means. Because of the tremendous development costs and the special needs of fragile proteins (most of which must be delivered by injection), the early and continuing efforts of those who determine the "recipe" and assure its stability and effectiveness are critical to the complex, interconnected stages of drug development.

The development process does not even begin until formulators accumulate enough data to assure that the drug candidate has a chance of succeeding. Bioanalysts ensure that the protein of interest remains viable through all stages of development and scale-up. Formulators examine how the product should be packaged, what it will be mixed with, how long it will last on the shelf (and under what conditions). Even before they know whether the drug will be tolerated by human subjects in clinical trials, they must decide whether it will be a liquid or freeze-dried formulation. They even have to consider, years before the drug may be approved, whether the ingredients they use are allowed in other countries in which the drug might be marketed.

The means of delivery into the patient's body isn't the only type of "drug delivery" of concern here. A biopharmaceutical has to get from the manufacturer to the clinic in the first place without suffering damage from heat, cold, or other physical stresses that occur during transportation. And with that need, a whole new set of regulations comes into play.

Acknowledgements

BioPharm International

thanks the following industry professionals for their help in preparing this guide.

Siddarth Advant, Director of Pharmaceutical Sciences and Stability, Diosynth

Tom Anchordoquy, Assistant Professor, University of Colorado School of Pharmacy

William M. Arden, Marketing Manager, Bosch Packaging Technology

Narlin Beaty, Chief Technical Officer, Chesapeake Biological Laboratories

Frank Bedu-Addo, Vice President, Purification Operations and Biopharmaceutics, KBI BioPharma

John Bontempo, Consultant in Biopharmaceutical Product Development

John Carpenter, Associate Professor, University of Colorado School of Pharmacy

Rajesh K. Gupta, Senior Consultant, Biologics Consulting Group

Chris Holloway, Group Director of Regulatory Affairs, ERA Consulting Group

Jean Huxsoll, Senior Director, QA, Chiron

Rajesh Krishnamurthy, Scientist in Formulation and Stability, Human Genome Sciences

John McEntire, Pharmaceutical Development Consultant

Tom Ransohoff, Senior Consultant, BioProcess Technology Consultants

Una S. Ryan, Chief Executive Officer, AVANT Immunotherapeutics

Bret Shirley, Senior Scientist in Formulation Development, Chiron

Krish Venkat, Director, Analytical Services, GlaxoSmithKline