VALD09005 2016 Bioprocess Validation
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.
On completion of this module the learner will/should be able to;
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.
Explain the necessity for post validation activities such as change control, ongoing process monitoring and process revalidation have in maintaining the validated state.
Develop a system of documentation necessary to support process validation activities such as protocols, operation and maintenance.
Contribute to the execution of process validation methodology, and develop the overall report to the process validation study.
Teaching and Learning Strategies
Online live and recorded lectures will be provided and there will be various forms of teaching and learning resources employed. Extra reading of peer reviewed journal articles and reviews will be provided.
Module Assessment Strategies
The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ’s/SAQ’s/LAQ’s, project assignments, written validations programmes, mini research projects, oral presentations, vivas etc.
The following is a summary of the main topics included in this particular module:
Regulatory requirements of biopharmaceutical manufacturing: ICH, FDA and EU guidelines, including current emphasis on risk and scientific based philosophies
Design, development and execution of a process validation study
Preservation of the fragile protein components throughout the manufacturing process and the validation of this.
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
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQs, project assignments, practical work, essays, oral presentations, vivas etc.||Continuous Assessment||UNKNOWN||100 %||OnGoing||1,2,3,4,5,6,7,8|
Full Time Mode Workload
|Independent Learning||Not Specified||Self Study||7||Weekly||7.00|
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
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)