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.
Inhaltsverzeichnis (Table of Contents)
- 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
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
This report outlines the detailed design and cost evaluation for a new manufacturing facility dedicated to producing DNA vaccines, to be constructed on a greenfield site. The facility will adhere to current good manufacturing practices (cGMP) and comply with relevant regulatory guidelines. The report aims to provide a comprehensive plan for the construction and operation of the facility, encompassing aspects such as plant layout, manufacturing flow, services and utilities, process validation, and cost analysis.
- Design and construction of a cGMP-compliant DNA vaccine manufacturing facility
- Detailed process analysis and flow for DNA vaccine production
- Integration of essential plant services and utilities
- Process validation and quality assurance for DNA vaccine manufacturing
- Cost analysis and economic evaluation of the project
Zusammenfassung der Kapitel (Chapter Summaries)
The report begins with a detailed introduction to the importance of DNA vaccines and the increasing demand for their production. It highlights the need for compliant manufacturing facilities to meet this demand. The following chapters delve into the specific process details, including fermentation, recovery, and product purification. Detailed descriptions of the facility's layout, room specifications, and key utilities are also provided. Subsequent chapters cover process validation and cGMP implementation, and the report concludes with a Gantt chart and a comprehensive cost analysis.
Schlüsselwörter (Keywords)
The core focus of this report is the design and construction of a DNA vaccine manufacturing facility. Key areas of focus include cGMP compliance, process design and validation, plant services and utilities, cost evaluation, and regulatory requirements. The report emphasizes the need for a robust and controlled manufacturing environment to ensure the safety, efficacy, and quality of DNA vaccines.
Frequently Asked Questions
What is the focus of this DNA vaccine manufacturing report?
The report details the design and cost evaluation for a new cGMP-compliant manufacturing facility for DNA vaccines to be built on a greenfield site.
Why is the demand for DNA vaccines increasing?
DNA vaccines are increasingly needed for gene therapy and to provide immune protection against diseases like cancer, malaria, and HIV, offering advantages over conventional vaccines.
What does cGMP stand for in this context?
cGMP stands for "current Good Manufacturing Practice," which refers to the regulatory guidelines and standards set by agencies to ensure product quality and safety.
What are CIP and SIP systems?
CIP stands for "Clean in Place" and SIP for "Sterilise in Place." These are automated systems used to clean and sterilize production equipment without disassembling it.
What utilities are essential for a DNA vaccine plant?
Essential utilities include HVAC systems for air control, purified water systems, clean steam, and specialized cleanrooms to maintain a sterile environment.
What is the accuracy of the cost evaluation in this report?
The cost analysis provided in the paper is estimated to be accurate within a range of +/- 20 percent.
- Citation du texte
- Sharyar Ahmed (Auteur), 2017, Plant Design and Manufacturing Principles in DNA Vaccine Production, Munich, GRIN Verlag, https://www.grin.com/document/903166
