What are the major technical obstacles to develop gene and cell therapy?
One of the most revolutionary trends driving the biopharmaceutical sector is cell and gene therapy. According to material published in The Journal of Gene Medicine, by November 2017, nearly 2600 gene therapy clinical trials have been conducted in 38 countries worldwide.
In a recent interview, Ger Brophy offered his perspective on this growing segment of the bioprocessing industry while discussing several key trends and challenges.
Many of the pioneers in cell and gene therapy were small biotech companies. Increasingly, we have all seen increased interest from the mainstream biopharmaceutical industry. Novartis was probably the largest; it started earlier and was successful in getting Kymriah's approval. As companies of this size become involved, we expect them to take advantage of their greater breadth and depth to develop new labels, develop new trials and find ways to manufacture these therapies at scale.
And two of the most critical challenges are scalability and manufacturing capability. If we can manufacture these treatments to scale, can we do so safely, can we do so at a reasonable cost so that populations affected by these diseases can access the treatments?
Variables and modes of failure must be eliminated from the process. If we can improve technologies such as sterile fluid transfer, use excipient technology to further stabilize these technologies and use analytical technology to understand what will make a therapy successful or less successful, we can increase efficacy, decrease risk and lower cost.
This is where Avantor can help, as we supply cell culture components, production chemicals and single-use technologies that assist in these processes. I believe that our knowledge, of cell culture, technology development, sterile fluid transfer, filling and finishing and excipients and the technology surrounding them, will be valuable and applicable in helping make these technologies available at scale.
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