Commercialization: Gene therapy process map

The emerging field of cell and gene therapy (CGT) has only recently started being commercialized and so standard methods for generating therapeutic products continue to change. Companies are developing their own procedures and many are following general biologics processes, which often do not apply to CGT. These divergent processes mean there is often confusion and inconsistency in the field – compounded by significant gaps in information describing industrial practices. This is why BioPhorum’s Cell & Gene Therapy Commercialization Workstream has generated a set of common CGT process maps that provide a superb education tool for companies and people new to the area.

The maps summarize the general, high-level process steps in CGT and can help readers quickly understand the normal manufacturing processes and can be used by novices to help them understand CGT or experts to help them share their expertise and let them take a deep-dive into the detail.

The gene therapy process maps can be used as an initial introduction to the in vivo gene therapy manufacture processes and act as an educational tool for people new to the field. The baseline maps can also be used to help drive discussions and identify specific areas that require further expansion. Example process maps (shown in the appendices) include those covering precursor adherent transient transfection (aTT) and downstream drug substance manufacture.