When introducing a regenerative medicine cell based product to a commercial setting, there are a number of things to take into consideration to ensure a commercially viable and safe product for patient use.
In this Q&A interview, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some great insights into the commercial manufacturing scale-up process of cell therapies.
The level of process efficiency behind today’s cell and gene therapies is said to rest at a low. The manufacturing behind them is mostly manual, due to the treatments mostly being within early development stages. There are, however, some cases where companies utilise partly automated solutions.
In regards to the progress required behind this market in regards to process excellence, Elena Meurer, Head of Pharmaceutical and Technical Development at apceth GmbH & Co.KG sees two major routes towards improvement.
For small autologous products - develop a strategy to produce everything at the patient side in the clinic, so for a closed automated system which will allow manufacturers to avoid the use of clean room. It is however not possible if the manufacturing of a cell product is lengthy due to a cell expansion phase. In this case, a simple, robust process should be developed to ensure the product’s success, as the patient material is valuable. Secondly, the adoption of allogenic manufacturing of huge batches that would allow for the cost minimisation.