Therapeutics


The modern challenges of cell therapy While cell therapies show great promise in bringing innovative and much needed treatments to patients, there are a number of key issues currently limiting their broader adoption. Safety concerns over the administration of live cells to patients, uncertainties over the way in which these therapies should be regulated, unknown downstream effects and the need for sufficient investment to fully com- mercialise research are all challenges that must be overcome in order to accelerate further develop- ment of cell therapies. Because of the huge potential for variability


within treatments, an additional challenge in cell therapy is the need for robust manufacturing pro- cesses that consistently deliver safe and effective products. Cell therapy manufacturing processes can range from the simple expansion of autologous cells that will be administered back to patients, to the complex genetic manipulation of allogeneic cells that could be stored and banked for the treat- ment of multiple patients. The regulations sur- rounding cell therapies must therefore be suffi- ciently broad to cover this wide range of therapeu- tic processes, while still safeguarding product safe- ty and quality. From a manufacturing point of view, autologous cell therapies can be more challenging to produce


Drug Discovery World Summer 2018


than allogeneic cell therapies, as each dose is a sin- gle batch and is derived from a different source. This presents problems for cell culture, as cells from different patients will behave in distinct ways and source material will contain a variety of cell types with various growth and differentiation capabilities. Additionally, if the cells are stored together there is an increased risk of contamination across batches. In contrast to autologous cell cultures, allogene-


ic cell therapy manufacturing processes are less prone to cross-contamination as they are usually derived from a single large batch. However, other manufacturing challenges remain. Maintaining product consistency throughout the different stages of development is often a difficult task as there are many variables that can affect cell growth. As such, developers of cell therapy prod- ucts must consistently monitor their processes and adopt the best cell culture methods to ensure that products are produced with the desired critical quality attributes.


Avoiding contamination in cell cultures Underpinning the major advances in cell therapy research is the need for robust cell culture condi- tions. Contamination of cell culture experiments is one of the most common problems encountered in


75


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80