VALD09002 2019 BIOPHARMA PROCESS VALIDATION

General Details

Full Title
BIOPHARMA PROCESS VALIDATION
Transcript Title
BIOPHARMA PROCESS VALIDATION
Code
VALD09002
Attendance
N/A %
Subject Area
VALD - Validation
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Stage
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler, Colin Fowley, Sharon Barrett
Programme Membership
SG_SBIPR_E09 201900 Certificate in Science in BioPharmaceutical Processing SG_SBIOP_M09 201900 Master of Science in Biopharmaceutical Science SG_SBIOP_O09 201900 Postgraduate Diploma in Science in Science in Biopharmaceutical Science
Description

The objective of this module is to give students a thorough appreciation of process validation considerations associated with the manufacture of biopharmaceuticals. The approach characterises the process development of a biopharmaceutical from when it progresses from the research entity off the laboratory bench, and forward to the initial clinical trials phase right up through to full scale manufacturing.

The focus is on the rational and science based decisions in determining the critical process parameters and quality attributes, and the subsequent setting of the manufacturing operational limits, with the ultimate goal of validating the full scale manufacturing process.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Describe and critically evaluate process validation considerations for biopharmaceuticals.

2.

Outline the standard industry validation definitions, terms and methodologies.

3.

Analyse and identify the process validation prerequisites in terms of validation planning and validation work flow.

4.

Evaluate the various process development considerations for the full scale manufacture of biopharmaceuticals, such as analytical methods, manufacturing equipment, facilities and process technology.

5.

Develop suitable validation approaches to achieve process validation over the product lifecycle.

Teaching and Learning Strategies

This Module will be delivered part time.

This will include online lectures augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment. 

Module Assessment Strategies

This Module is 100% Continuous assessment

Continuous assessment-1 (20%)

 Will involve a short written assignment Assignment. This will focus of which on current and future regulatory guidance or relevant Validation trends.

 

Continuous Assessment Continuous assessment-2 (30%)

Will be a live online quiz, long answer question (LAQ) format. Covering a broad range of topics across all three stages of process validation.     

 

Written project report (40%)      

Detailed reported critically evaluating various aspects of the lifecycle approach to validation.

 

Continuous Assessment Technical Presentation (10%)

Covering an industry relevant validation activity.

Repeat Assessments

Repeat continuos assessment 

Indicative Syllabus

1. Describe and critically evaluate process validation considerations for biopharmaceuticals.

Analysing prerequisites  to process validation, 

Focusing on stage 1 process design

2. Outline the standard industry validation definitions, terms and methodologies.

Discussion of the latest FDA, EMA and ICH guidances.   

3. Analyse and identify the process validation prerequisites in terms of validation planning and validation work flow.

Analysing prerequisites  to process validation, 

Focusing on stage 1 process design

Focus on process characterisation, defining CCP and CPA 

4. Evaluate the various process development considerations for the full scale manufacture of biopharmaceuticals, such as analytical methods, manufacturing equipment, facilities and process technology.

Focus on phase two and qualification requirements pre and post PPQ consideration.  

5. Develop suitable validation approaches to achieve process validation over the product lifecycle.

Examination of QBD concepts, CPV and the lifecycle approach. 

 

The following is a summary of the main topics included in this particular module:

o   Regulatory requirements of biopharmaceutical manufacturing: ICH, FDA and EU guidelines, including current emphasis on risk and scientific based philosophies

o   Design, development and execution of a process validation study

o   Nature of a protein, its conformational shape and structure, and how it's manufactured.

o   Preservation of the fragile protein components throughout the manufacturing process and the validation of this.

o   Profiling techniques for proteins and nucleotides in order to characterise the moieties, and assist in the development of specific-activity protein assays.

  • Fundamental biological concepts applicable to industrial biotransformations, and validation considerations: for example recombinant DNA technology, antibody manufacture, mammalian cell cultures and microbial cell fermentations
  • Protein purification techniques, with a view to preserving the efficacy and integrity of the proteins, and increasing specific activity with the least number of processing steps while achieving acceptable viral clearance.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous assessment-1 (20%) will involve a short written assignment Continuous Assessment Assignment 20 % Week 4 1,2
2 Continuous assessment-2 (30%) will be a live online quiz, long answer question (LAQ) format Continuous Assessment Assessment 30 % Week 10 1,2,3,4
3 Written project report (40%) Project Project 40 % End of Semester 4,5
4 Technical Presentation Continuous Assessment Individual Project 10 % Start of Semester 4,5

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 7 Weekly 7.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Module Resources

Non ISBN Literary Resources

ICH, International Conference on Harmonisation (ICH) guidelines Q7, Section 18., ICH, 2003

PDA Technical Report-42 (2005) and PDA Technical Report-42 (2013)

ISPE, ISPE Base line Guide No. 6., ISPE, 2004

Kelly, D., Validation of Biopharmaceutical Manufacturing Processes., American Chemical Society, 2003

Journal Resources

Various 

URL Resources

Various 

Other Resources

EU cGMPs Eudralex Annex 2 online (http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm)

Current FDA guidance for process validation.

United States code of federal regulations, series 600, available online (www.fda.gov)

Additional Information

None