VALD09002 2019 BIOPHARMA PROCESS VALIDATION

Describe and critically evaluate process validation considerations for biopharmaceuticals.

Outline the standard industry validation definitions, terms and methodologies.

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

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

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

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. 

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 continuos assessment 

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.