BIO09087 2019 Quality Control Testing for Biologics.
This course is designed to provide specialised knowledge in the theory, practice and interpretation of the various assays and instrumentation routinely employed in a biologics quality control (QC) testing laboratory. Biologic therapeutics have numerous critical quality attributes (CQA’s) that can potentially impact drug safety and efficacy. Consequently, many orthogonal techniques are required for the analysis of biological drugs. This course guides students through the CQAs of biologics (ICH Q6B) as well as core analytical methods and platforms routinely employed in a QC testing laboratory to measure them. The necessary skills and competencies will be acquired through a combination of lectures, hands-on practical training and demonstrations plus self-study. The course will cover methods such as spectroscopic, chromatographic, electrophoretic and mass spectrometric approaches for the analysis of biological drugs plus new and emerging technologies as they arise.
On completion of this module the learner will/should be able to;
Describe test specifications, CQA’s and the routine testing strategies typically employed for the routine analysis of biologics.
Outline and evaluate the main QC test methods and bioanalytical instrumentation routinely employed in the analysis of biologics by sourcing and interpreting the theory behind the methods from a wide range of information sources to demonstrate an in-depth knowledge of the subject matter.
Perform a range of analysis and interpret and critically evaluate the data obtained from practical’s and demonstrations and solve/troubleshoot analytical problems.
Develop professional practice skills including time-management, scientific writing and oral communication skills.
Teaching and Learning Strategies
This module will be delivered full time and will include lectures, laboratory practicals (at IT Sligo), and a one day site visit to the pilot scale Bioprocessing facility at NIBRT for practicals, demonstrations and a tour of the facility. Laboratory practicals in IT Sligo will take place over 3 full days during the course of the semester. It is intended to run the practicals in this format as it simulates a 'real' work environment in a QC laboaratory. This teaching and learning strategy will be augmented by both independent and directed learning strategies. Moodle will serve as the repository for educational resources (e.g., lectures, online resource information, access to journals etc) and also as a means of assessment (e.g. quizzes, uploading of assignments, practicals etc.).
Module Assessment Strategies
This module will be assessed using a combination of end of semester final exam (25%) and continuous assessment of theory (25%) and laboratory practicals (50%).
The continuous assessment and course work will involve one MCQs mid semester (10%) to monitor progress during the course, one project assigned early in the Semester with a submission date later in the Semester and a presentation following submission of the project (15%). The project and presentation should demonstrate the student's ability to critically evaluate an aspect of Analysis of Biological Drugs and to demonstrate effective communication skills. The final exam will offer students the opportunity to communicate their knowledge and understanding of the module content during a closed book exam the last teaching week of Semester (25%).
Laboratory skills, report‑writing and critical analysis of results will be assessed as part of the continuous assessment aspect of this module which will be examined through the submission of lab reports, data analytics and problem solving approaches. A minimum of 75% attendance at laboratory sessions is required.
Repeat continuous Assessment and/or final exam.
LO1) Describe test specifications, CQA’s and the routine testing strategies typically employed for analysis of biologics.
The learner will be able to explain the specifications and acceptance criteria for biotech products (ICH Q6B), including CQA’s such as residual host-cell protein, DNAs, endotoxin, protein aggregates, and biological potency that can potentially impact safety and/or efficacy of the product. They will also be able to explain routine stability and lot release testing regimes.
LO2) Outline and evaluate the main QC test methods and bioanalytical instrumentation routinely employed in the analysis of biologics by sourcing and interpreting the theory behind the methods from a wide range of information sources to demonstrate an in-depth knowledge of the subject matter.
Participants will study the theoretical aspects of spectroscopic, chromatographic, Realtime PCR, electrophoretic and mass spectrometric approaches for the analysis of biologics. Students are expected to critically review key literature to acquire an in-depth knowledge of the subject matter.
LO3 Perform a range of analysis and Interpret and critically evaluate the data obtained from practical’s and demonstrations and apply scientific and technical information to solve/troubleshoot analytical problems.
The range of laboratory‑based practical’s covered may include some or all the following assays/instrumentation; Spectrophotometry and Protein assays; Sodium dodecyl sulfate‑polyacrylamide slab gel electrophoresis (SDS‑PAGE), Capillary Electrophoresis (CE), Immunoassays, Polymerase Chain Reaction, Realtime PCR, Liquid Chromatography and Mass Spectrophotometry. Additional laboratory-based practical’s/demonstrations will be offered as new and emerging technologies/test methods emerge.
Students will also perform data analysis and solve/troubleshoot analytical problems. Completed work will demonstrate the knowledge, skills and competency appropriate to a level nine module.
LO4) Develop professional practice skills including time-management, scientific writing and oral communication
Critical thinking skills will be developed through critical analysis of theoretical and laboratory data and the presentation of results in the format of both oral and written formats.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Continuous Assessment||Continuous Assessment||Multiple Choice||10 %||Week 8||2|
|2||Project Project plus Project Presentation||Continuous Assessment||Project||15 %||OnGoing||4|
|3||Practical labs and demonstrations||Practical||Practical Evaluation||50 %||OnGoing||3,4|
End of Semester / Year Assessment
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Final Exam||Final Exam||Closed Book Exam||25 %||End of Semester||1,2,4|
Full Time Mode Workload
|Laboratory Practical||Science Laboratory||Laboratory Practicals and demonstrations||30||Once Per Semester||2.00|
Required & Recommended Book List
2019-04-15 Introduction to Pharmaceutical Analytical Chemistry 2e Wiley
ISBN 9781119362722 ISBN-13 1119362725
The definitive textbook on the chemical analysis of pharmaceutical drugs fully revised and updated Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals. This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension. Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject Examines various analytical techniques commonly used in pharmaceutical laboratories Provides practice problems, up-to-date practical examples and detailed illustrations Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.
Analytical Techniques for Biopharmaceutical Development. Author(s): Roberto Rodriguez-Diaz, Tim Wehr, Stephen Tuck. ISBN 9780824722258. Publisher Boca Raton CRC Press, 2005.
Various reading sources will be either provided or recommended by the module tutor in Moodle.
Links to journals will be provided in Moodle.
Links to other resources will be provided in Moodle.