BIO09087 2019 Quality Control Testing for Biologics.

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.

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.).

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.