BIOC09002 2023 Cell processing 2 with QC Analytical Techniques

Describe the production cycle of a therapeutic cell product from donor to patient, being cognisant of the phenotypic and functional characteristics of cell therapies, patient safety, GMP and other regulatory conditions.

Describe and evaluate different transfection techniques for cell modification

Appraise new technologies for cell sorting, formulation etc and compare different methodologies for different cell products

Formulate judgement on appropriate QC tests and analyse simulated QC data

Construct proposals for an application of cell therapies to meet an unmet clinical need and defend safety, societal and ethical impacts of these technologies.

A virtual learning environment (e.g. Moodle) will be used as a repository of educational resources and as a means of assessment. Self‑directed, student‑centred, independent learning is a core aspect through completion of module coursework.

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, essays, oral presentations, vivas etc. An example of the end of semester assessment could involve students synthesising and defending new technologies, which will also be assessed via oral presentation.

Repeat continuous assessment of the failed elements, in line with marks and standards

• Describe the production cycle of a therapeutic cell product from donor to patient, being cognisant of the phenotypic and functional characteristics of cell therapies, patient safety, GMP and other regulatory conditions.

1. What are stem cell therapies / what are CAR-T / CAR-NK therapies / new and emerging cell based therapies (e.g. exosomes)
2. Allogenic V Autologous
3. 3D culture
4. Cell washing and cell selection- evaluate marketed cell processing systems for isolation, harvesting, and final formulation of cellular products / cryopreservation
5. Regulatory requirements of allogeneic donor recruitment / bone marrow (starting material) collection. 

• Describe and evaluate different transfection techniques for cell modification

1. Introduce viral / non viral vectors
2. Current / emerging transfection strategies and their advantages / disadvantages  

• Appraise new technologies for cell sorting, formulation etc and compare different methodologies for different cell products
  1. Cell Selection / expansion/ activation – e.g. magnetic bead based or antibody coated culture bags etc
  2. Scale up technologies
• Formulate judgement on appropriate QC tests and analyse simulated QC data
  1.  QC release tests (e.g. identity, potency, viability etc)
  2.  Release requirements
• Evaluate the ethical and societal impact of these cell products.
  1. Guiding ethical principles will be applied to case scenarios, and concepts such as irreducible uncertainly, translational distance, beneficence V non maleficence etc. explored in introducing these cell products
  2. Societal questions on the value of these technologies will be explored