BIO09035 2019 Bioanalytical Techniques

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

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.

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

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

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.)

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 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 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.