Aline Hughson

Main work involves process development and technology transfer for gene therapy: - Upstream process optimization, from shake flasks and 250 mL bioreactor to 200 L bioreactor - Clarification - Downstream optimization - Tangential Flow Filtration (TFF) - Technology Transfer

My work at The Cell and Gene Therapy Catapult involved the development of a next generation platform for allogeneic stem cell production which encompassed several features of bioprocessing, with optimisation of cell expansion, scale up, harvest and concentration. I worked on a project that developed a process to produce exosomes from neuronal stem cells. This was a pre-clinical project to determine therapeutic potential of exosomes for a number of indications. Optimal neuronal stem cell expansion conditions were successfully determined by screening multiple cell support structures and different coatings for cell expansion and growth. The optimal conditions were then scaled up into stirred tank reactors which also required the optimisation of several process parameters: cell attachment strategy, seed density, microcarrier concentration, impeller speed, feeding regime etc. Maintaining cell adherence to the support structure was especially challenging during scale-up. I also worked on cost of goods reduction project for induced pluripotent stem cells production in suspension using microcarriers

Duties included planning and logistic control of purchasing, receiving, storage, distribution and disposal of medicines and health products in accordance with the internal rules and corresponding ordinances; distribute the required medication to patients; provide pharmaceutical support to outpatients, inpatients or day hospital patients, promoting the safe and rational use of medicines and related products; provide training and development of technical staff at the pharmacy; maintain and control stock; prepare purchase orders for medications; management of federally controlled prescription drugs; conducting periodic inventories.

My duties included the reconciliation of historical batches of the medicinal products and medical devices produced, aid in the release of the finished product through the sales and distribution system, archiving all documentation, control and treatment of non-compliance in the documentation and preparation of management reports.