Biotech

Introduction

The biotechnology industry is based largely on a recombinant DNA method of making proteins-such as human insulin and other therapies-in cultured cells under controlled manufacturing conditions. From early beginnings in the 1970’s the industry has grown to over £500 billion turnover and continues to grow at a fast rate. Some predict that in the future biotechnology products will be around 50% of all drugs. Fermentation is the basis of most commercial biotechnology manufacture followed by technology to extract and purify the key product from the large volumes of fluid involved in fermentation. The Biotech industry is regulated by the U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA).

A key challenge of the biotechnology industry is the cost of manufacture and purification of the products. Considerable capital and operational investment is required to manufacture a relatively small volume but highly effective product. Controlling the fermentation is complex as it is biological reactions and measurement inside the fermentation stage is difficult due to the two or more phases present.

Solution

Process tomography can provide benefits in process understanding, process control and process development. For example, electrical tomography can provide information on the quality of suspensions, performance of chromatography columns, mixing and homogeneity in process vessels.

As part of its validation offering for the p2000 Electrical Resistance Tomography system, ITS is able to supply the following:

Quality Management System

Validation Policy, QMS Document Register, Approach to Validation Procedure

Specification Phase

Validation Plan, User Requirement Specification, Functional Specification, 21 CFR Part 11 Assessment, Requirement Traceability Matrix

Design Phase

Configuration Spec, System Hardware Build

Testing Phase

FAT Spec, FAT Execution & Reporting, Site Installation, User’s Manual

Qualification Phase

IQ, OQ & PQ Protocols, IQ, OQ & PQ Execution and Reporting, SOP – Normal Operation, SOP – System Administration, SOP – Maintenance & Calibration, SOP – Backup & Restore, Training, Validation Report