Manufacturing Technology

Single Use, Process Management


The Holy Grails of biopharmaceutical production effi ciency are low installation and operating costs, coupled with short startup and rapid turnaround times that result in enhanced plant flexibility, all partnered with world-class vendor quality and regulatory support.

The pharmaceutical industry faces increasing challenges from globalization, government regulation and pressure to reduce prescription drug costs.

BARBARA A. PALDUS, MARK SELKER and ALFY RIDDLE, from Finesse, discuss changes in bioprocessing.

Single-use technologies are being used by many biopharmaceutical manufacturers to improve facility throughputs, by significantly reducing downtime between campaigns. Adoption of disposables also promotes the development of a multi-purpose plant design because of the inherent flexibility of disposable systems.

Chris Watts Ph.D., Team Leader, Standards and Technology, FDA/CDER/OPS, takes a look at FDA initiatives that help mitigate risks in drug development.

 
 
The success of recombinant DNA technology derived biopharmaceuticals has necessitated the construction of large manufacturing plants...
Richard Forsyth, an Associate Director with GMP quality in Merck & Co. Inc., discusses the cleaning validation process, visual residue limits and disposable technologies.
Jason J. Kamm, Managing Consultant with Tunnell Consulting, and Philippe Cini, Ph.D., Vice President of Tunnell Consulting, discuss the advantages of a proper PAT platform.
Humberto Vega, Process Engineer of Bio Sterile Validation with Merck & Co., and Timothy J. Schultz, Process Scientist of Commercialization with Merck & Co. discuss the history of disposables and how they are being applied today.
 
 

Carol Rozwell
Jason J. Kamm
Philippe Cini
Dr. Hans H. Schicht
Richard Forsyth
Lewis T. Kontnik