BIO09035 2019 BIOANALYTICAL TECHNIQUES

General Details

Full Title
BIOANALYTICAL TECHNIQUES
Transcript Title
BIOANALYTICAL TECHNIQUES
Code
BIO09035
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler, Sharon Barrett
Programme Membership
SG_SBIOP_M09 201900 Master of Science in Biopharmaceutical Science SG_SBIOP_O09 201900 Postgraduate Diploma in Science in Science in Biopharmaceutical Science SG_SQUAL_E09 201900 Minor Award in Science in Bioanalytical Techniques SG_SBIPR_E09 201900 Certificate in Science in BioPharmaceutical Processing
Description

This module aims to provide students with a detailed knowledge and understanding of the various analytical test methods used in a biopharmaceutical Quality Control laboratory. The module will focus on the scientific principles behind each method, analytical platforms used and their application in biopharmaceutical analysis.

Learning Outcomes

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

1.

LO1) Describe test specifications, CQA’s and the routine testing strategies typically employed for analysis of biologics.

2.

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.

3.

LO3 Formulate and communicate judgements with regard to current and emerging biopharmaceutical analytical techniques and instrument platforms.

4.

LO4) Develop professional practice skills including time-management, scientific writing and oral communication skills.

Teaching and Learning Strategies

This module will be delivered on-line and the primary mode of dissemination will be lecture delivery either using both live and recorded lectures.  This format will be augmented by both independent and directed learning strategies. A learning platform (such as moodle) will be used as a repository of educational resources (e.g. journals, online resource information) and also as a means of assessment (e.g. quizzes, uploading of assignments etc.)

 

 

Module Assessment Strategies

This module will be assessed using 100% continuous assessment. Continuous assessment of the course will include two MCQs during the Semester (20%) to monitor progress during the course and one final long answer questions exam which 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 (30%).

The students will also be assigned a project early in the Semester with a submission date later at the end of Semester and a presentation following submission of the project (50%). The project and presentation should demonstrate the student's ability to critically review an aspect of Analytical testing of Biological Drugs and to demonstrate effective communication skills. The miniproject is a MANDATORY form of assessment this module.

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, etc.).

Students may elect to take a laboratory module to complement this theory module at a later date in NIBRT. 

Repeat Assessments

Repeat continuous Assessment and/or final exam.

 

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

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 Formulate and communicate judgements with regard to current and emerging biopharmaceutical analytical techniques and instrument platforms.

Participants will complete a project on a current or emerging biopharmaceutical analytical technique. They can choose to work on a project of their own choosing or be assigned a project by the lecturer. 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 skills.

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

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ Continuous Assessment Multiple Choice 10 % Week 5 1,2
2 MCQ Continuous Assessment Multiple Choice 10 % Week 9 1,2
3 Project and Presentation Project Essay 50 % End of Semester 3,4

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 LAQ Final Exam Closed Book Exam 30 % Week 12 1,2,3,4
             
             

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

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

 

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

Recommended book lists will be supplied in the Moodle page for the subject.

 

Journal Resources

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

Various reading sources will be either provided or recommended by the module tutor in Moodle.

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.

Other Resources

Moodle and link to Live Lecture room will be provided.

Additional Information

None