BIO08030 2019 ANALYTICAL TESTING OF BIOPHARMACEUTICALS

General Details

Full Title
ANALYTICAL TESTING OF BIOPHARMACEUTICALS
Transcript Title
ANALYTICAL TESTING OF BIOPHARM
Code
BIO08030
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Sharon Barrett
Programme Membership
SG_SMEDI_H08 201900 Bachelor of Science (Honours) in Science in Medical Biotechnology SG_SMEDI_K08 201900 Level 8 Honours Degree Add-on in Science in Medical Biotechnology
Description

This course is designed to provide specialised knowledge in the theory, practice and interpretation of the various assays and instrumentation routinely employed in a routine biologics quality control (QC) testing laboratory. This course guides students through the core analytical methods and platforms routinely employed in a QC testing laboratory. 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.

Learning Outcomes

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

1.

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.

2.

Perform a range of analysis and interpret and critically evaluate the data obtained from practicals and demonstrations and solve/troubleshoot analytical problems.

3.

Develop professional practice skills including scientific writing report writing and oral communication skills.

Teaching and Learning Strategies

This module will be delivered fulltime. This will include lectures and laboratory practicals in IT Sligo 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 (e.g. quizzes, uploading assignments and laboratory reports).

Module Assessment Strategies

This module is 50% Continuous Assessment and 50% Final Terminal Exam.

The module will be assessed using a combination of end of semester final exam (50%), continuous formative assessment  plus laboratory based practicals and demonstrations (50%).

The continuous assessment and course work will involve one MCQs mid semester  to monitor progress of the theory during the course. Laboratory skills and data analysis plus report‑writing ability are assessed continuously as part of the practical work performed during the module (50%).

One final terminal exam will exmine the theory content of the module (50%).

 

Repeat Assessments

Repeat continuous Assessment including practical reports and/or final exam.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

LO1 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.

Participants will study the theoretical aspects of spectroscopic, chromatographic, PCR, Realtime PCR, electrophoretic and mass spectrometric approaches for the analysis of biologics. Students will also be introducted to protein characterisation, release testing and stability testing. Students are expected to critically review key literature to acquire knowledge of the subject matter.

LO2 Perform a range of analysis and interpret and critically evaluate the data obtained from practicals and demonstrations and solve/troubleshoot analytical problems.

The range of laboratory based practical's/demonstrations covered may include some or all the following assays/instrumentation; Spectrophotometry and Protein assays; Sodium dodecyl sulfate polyacrylamide slab gel electrophoresis (SDSPAGE), 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 eight module.

LO3 Develop professional practice skills including scientific writing report writing and oral communication skills.

Critical thinking skills will be developed through critical analysis of theoretical and laboratory data and the presentation of results in both oral and written formats.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Practical Evaluation Assessment of practicals and continuous assessment of theory Continuous Assessment UNKNOWN 50 % OnGoing 2,3
             
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam UNKNOWN 50 % End of Term 1,2,3
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 2 Weekly 2.00
Laboratory Practical Science Laboratory Laboratory Practical 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 3 Weekly 3.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Required Reading
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.

Module Resources

Non ISBN Literary Resources

Recommended book list will be provided in Moodle page.

 

Analytical Techniques for Biopharmaceutical Development. Author(s): Roberto Rodriguez-Diaz, Tim Wehr, Stephen Tuck. ISBN 9780824722258. Publisher Boca Raton CRC Press, 2005.

https://the-eye.eu/public/Books/Medical/texts/Analytical%20Techniques%20for%20Biopharmaceutical%20Development%20-%20R.%20Rodriguez-Diaz%2C%20et%20al.%2C%20%282005%29%20WW.pdf

Journal Resources

http://biomanufacturing.org/uploads/files/380009860690819115-chapter-7.pdf

URL Resources

https://bioprocessintl.com/category/analytical/qa-qc/

http://www.biopharminternational.com/

https://www.fda.gov/iceci/inspections/inspectionguides/ucm074918.htm

https://www.ema.europa.eu/en/documents/scientific-guideline/specifications-control-tests-finished-product_en.pdf

https://drug-dev.com/category/analytical-testing/

https://drug-dev.com/special-feature-analytical-testing-of-biologics-biosimilars/

Links to other resources will be provided in Moodle.

 

Additional Information

None