Essays on Good Manufacturing Practice

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 ...

Introduction

Pharmaceutical companies should create and follow a standard operating procedure by implementing a cleaning validation to ensure future patient safety. Validation has received great attention by the FDA in recent inspections. Manufacturers must validate their cleaning process to ensure compliance with GMP regulations 1. One of the main keys in the manufacturing of dosage formulation is to develop cleaning procedures that will remove all types of residues from the equipment and containers. The goal of Cleaning Validation is to ensure effectiveness in cleaning equipment, and to prevent pollution and cross contamination of drug products to ensure the quality, safety; efficacy and ...