Plant Design and Manufacturing Principles in DNA Vaccine Production

Bachelor Thesis , 2017 , 37 Pages , Grade: 80.0

Chemistry - Bio-chemistry

This paper covers a detail design and cost (to an accuracy of +/- 20 percent) for a new manufacturing facility to produce DNA vaccines to be built on a greenfield site. Applied current good manufacturing practice (cGMP) and complied with all the regulatory guidelines set up by various agencies.

The demand for DNA vaccines in large quantities at high purity for gene therapy is on the increase. As it helps to stimulate antibodies production in human and provide immune protection against many diseases such as cancer, malaria, HIV and other diseases and have potential advantages over conventional vaccines.

Contents

Abstract

1.0 Introduction
1.1 Aims/objective

2.0 Detail of the process
2.1 Process description
2.2 Raw material required
2.3 Equipment required
2.4 Staff Involved

3.0 Design of Manufacturing facility
3.1 Plant location
3.2 Plant layout
3.21 Layout of the Plant site appendix 1
3.22 Layout of the Production House appendix 2
3.3 Manufacturing Flow.
3.4 Room Specification data sheets appendix 3

4.0 Plant Services, Systems and Utilities
4.1 Heating, ventilation and air-conditioning (HVAC) system
4.2 Water
4.3 Clean steam.
4.4 Heat and power
4.5 Cleaning Systems
4.51 Clean in Plane (CIP)
4.52 Sterilise in Place (SIP)
4.6 Cleanrooms
4.7 Process control & instrumentation Instrumentation

5.0 Process Validation and cGMP
5.1 Process Validation
6.0 Gannt Chart
7.0 Costing
8.0 Conclusion
9.0 References

Appendix
Appendix 1 Layout of the Plant site
Layout of the Production House Appendix 2
Gantt Chart Appendix 4
Costing Appendix 5

• College: University of Birmingham (Engineering)
• Course: Chemical Engineering
• Grade: 80.0
• Author: Sharyar Ahmed (Author)
• Publication Year: 2017
• Pages: 37
• Catalog Number: V903166
• ISBN (eBook): 9783346248244
• ISBN (Book): 9783346248251
• Language: English
• Tags: Plant Design, Chemical Engineering, DNA Vaccine, Bio Pharmaceutical, engineering, Manufacturing Principles