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.
“There is a wide variety of therapy types manufactured by member companies and within each therapy type there are many different technology platforms or possible unit operations,” said Scott Probst, Unit Head of Technical Development and Support at Bayer Pharma.
He added that because people had very different backgrounds, knowledge and experiences “it was necessary to define a common context in which we could discuss development or manufacturing challenges. The maps attempt to represent the spectrum of processes used within our CGT community and serve as a communication platform for our future collaborations.”
The maps 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.
John Kerwin, Senior Manager, Gene Therapy Manufacturing Sciences at Biogen said, “Experts will be able to appreciate the diversity of the approaches described in the maps, and will be able to start to leverage best practices, orthogonal approaches or different platforms and fold these into their current strategy for further optimization.”
Probst added, “For novices, the maps are a good place to start when trying to learn about manufacturing processes with which they are unfamiliar. The maps provide a preliminary orientation to folks who are just getting started and can help individuals start asking insightful questions faster.”
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 & cell banking.
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 Manufacturing.
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.
The Commercialization Workstream will continue to leverage the process maps as tools to identify future challenges and potential mitigation strategies to drive improvement and standardization in CGT manufacturing.
Industry reports suggest there are more than 630 current clinical trials for cell- and gene-modified cell therapies, with nearly 55% of these in Phase II. The numbers are staggering but these therapies pose unique manufacturing challenges – yet unlike the conventional biologics industry, CGT production standards have yet to be established. BioPhorum’s process maps are a great first step to achieve clear thinking about CGT.