Essays on Cgmp

Commercializing Biotechnology in Early-Stage Ventures.

Introduction: Ajinomoto Althea, Inc. is a drug manufacturing and contract development organization that provides clinical drug manufacturing and process development services to various global pharmaceutical and biotechnology firms. The company claims to be capable of fully supporting early stages clinical requirements via commercial manufacturing.

History and Background Information:

Althea Inc. was founded in 1998 by Francois Ferre, Ph.D. and Magda Marquet, Ph.D. and its first products were gene quantification assays and plasmids kits. The company delved into manufacturing microbial biologics in 2000, and by 2003, the company was now offering finish and fill manufacturing services to meet client demands. In 2008, due to ...

Question 1

Testing alone cannot be used as the only measure of ensuring the quality of a product. The quality is based on the desired purity, strength, identity, and other characteristics. Hence, the FDA can only protect the average consumer by assuring the final good meets the criteria for effectiveness and safety. Otherwise, simply inspecting the international manufacturing facilities does not help the average buyer. The organization needs to establish a quality system that will oversee the measurements, evaluate and document the changes, and provide an action program that will address the issues that affect the product quality and performance (Buckley ...