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CHEP8026 - Process Technology Transfer

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Title:Process Technology Transfer
Long Title:Process Technology Transfer
Module Code:CHEP8026
 
Duration:1 Semester
Credits: 5
NFQ Level:Advanced
Field of Study: Chemical & Process Eng
Valid From: Semester 2 - 2018/19 ( January 2019 )
Module Delivered in 3 programme(s)
Module Coordinator: NIALL MORRIS
Module Author: Caroline OSullivan
Module Description: The process of transferring products and processes from research scale to manufacturing scale or from one location site to another site. Involves: life cycle studies, raw material impacts, pilot plant studies, validation, commissioning and cleaning.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Assess critical issues in the transition from research project to product launch in the Pharmaceutical and/or Medical Device industry.
LO2 Create and troubleshoot a technology transfer protocol for a Pharmaceutical scale-up / Pharmaceutical process / Medical Device product transfer.
LO3 Critically analyse the key technology transfer aspects of the validation process.
LO4 Develop a QbD approach to a pharmaceutical unit operation.
LO5 Develop a plan to implement a technology transfer project and critically evaluate its success.
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.

No requirements listed
 

Module Content & Assessment

Indicative Content
Introduction to Technology Transfer
Concept of Technology Transfer: sender and receiving units, transfer examples, considerations, importance to industry, regulatory drivers and regulators. Case Study: multi-use facility design
Drug and Manufacturing Development Process
Regulatory framework and lifecycle for pharma and biopharma products: drug development process from discovery to drug registration. Product lifecycle: bench top reactions to manufacturing scale. Process development: chemical development phase; process operations development; product-process support phase. Scale-up considerations: planning; trouble-shooting; health, safety and environmental impact; technology transfer aspects. Case studies: chemical synthetic routes and biopharmaceutical processing.
And/or Medical Device Development Process
Regulatory drivers and framework for medical device products: product lifecycle; product classifications; scale-up considerations; preclinical and clinical trials. Product routes to market: pre-market approval (PMA) and 510K. Case studies: medical device scale up from concept to production.
Validation in Technology Transfer
Validation introduction: definitions; benefits; strategies; models. Pre-validation steps: system impact assessment and commissioning. Equipment qualification steps: design (DQ), installation (IQ); operational (OQ); performance qualifications (PQ). Process validation (PV): definitions and considerations. Change control and revalidation. Case studies: HVAC system (office and clean room environments); reactor vessel.
Cleaning Validation
Validation versus verification. Importance of cleaning validation. Regulatory drivers. Elements of cleaning validation: strategies; Clean-In-Place and Clean-Out-Place (CIP and COP) systems and operations; verification methods; establishments of limits and documentation. Case studies: cleaning validation for a biopharma manufacturing process by Genentech; validation of a CIP system. IQOQ of a CIP skid: IQOQ protocol development; understanding of PID for a process water tank and CIP tank and corresponding line, equipment and instrument lists; critical component impact assessment; traceability matrix; IQ/OQ tests and GMP test sheets.
Quality by Design (QbD)
Concept of QbD. ICH Q10 guidelines. Critical to quality parameters (CQA and CPP) for pharma and biopharma processes. Overall strategy steps involved in QbD. Quality risk management and risk assessment tools. Case studies: Application of FMEA in upstream processing; QbD using risk analysis and mitigation matrix (RAMM); production of monoclonal antibodies; chromatography unit operation; operation of a bioreactor.
Successful Technology Transfer
Goals of technology transfer: regulatory and business perspectives. Technology Transfer project roadmap. Common errors made.
Assessment Breakdown%
Course Work30.00%
End of Module Formal Examination70.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Project Case study relevant to the pharma/medical device industry on critical issues in technology transfer and how to resolve them. 1,2,3,4,5 30.0 Week 10
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3,4,5 70.0 End-of-Semester
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The institute reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class Room Instruction 2.0 Every Week 2.00
Lecturer-Supervised Learning (Contact) Project Guidance 1.0 Every Week 1.00
Independent & Directed Learning (Non-contact) Student Input 4.0 Every Week 4.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class Room Instruction 2.0 Every Week 2.00
Lecturer-Supervised Learning (Contact) Project Guidance 1.0 Every Week 1.00
Independent & Directed Learning (Non-contact) Studnt Input 4.0 Every Week 4.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 

Module Resources

Recommended Book Resources
  • International Society for Pharmaceutical Engineering 2014, ISPE Good Practice Guide: Technology Transfer, 2nd Ed., International Society for Pharmaceutical Engineering [ISBN: 979 1 9363797]
  • David J. Am Ende (Ed) 2010, Chemical Engineering in the Pharmaceutical Industry R&D to Manufacturing, John Wiley & Sons Inc https://www.dawsonera.com/readonline/9780470882214 [ISBN: 9780470882214]
  • Warren D. Seider 2009, Product and process design principles, John Wiley Hoboken, NJ [ISBN: 9780470048955]
  • Anurag S. Rathore (Editor), Process Validation in Manufacturing of Biopharmaceuticals, Third Edition Ed., CRC Press [ISBN: 978-1-43-9850]
  • Robert A. Nash, Alfred H. Wachter 2003, Pharmaceutical Process Validation, Third Edition Ed. Ed., Marcel Dekker New York [ISBN: 9780824708382]
Recommended Article/Paper Resources
  • Rathore, AS, and H. Winkle. 2009, Quality By Design for Biopharmaceuticals, Nat. Biotechnol., 27, 26-34
  • Brindle, A & Davy, S & Tiffany, D & Watts, C. 2012, Risk Analysis and Mitigation Matrix (RAMM) - A risk tool for quality management., 32, 26-33
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_ECPEN_8 Bachelor of Engineering (Honours) in Chemical and Biopharmaceutical Engineering 8 Elective
CR_EPIAI_9 Certificate in Process Industries Advancements and Innovation 2 Mandatory
CR_ECHBI_9 Master of Engineering in Chemical and Biopharmaceutical Engineering 2 Mandatory

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