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 cell therapy process maps reflect the current state of selected manufacturing processes within the cell therapy field. They form a common frame of reference for scientists and engineers working within the field and support collaboration to enable process improvements benefitting future cell therapy patients. Example process maps (shown in the appendices) include those covering autologous cell therapy: viral gene editing manufacturing process and allogeneic cell therapy: iPSC generation and cell banking.
Without these maps, companies might find it takes longer to find a common language and reach common solutions. The maps will help align terminology, understanding and key processes, not just across the industry but within companies. They also provide a common frame of reference and will help prevent misunderstandings when solutions are being developed.