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Although viral vector methods can effectively load cells, they are challenged by logistical and regulatory hurdles. Regulatory concerns about safety (carcinogenicity, unintended activity and toxicity) have resulted in the standard requirement for additional toxicology studies and their associated costs for viral methods. Scalability and consistency concerns also challenge such methods.
With its biologically neutral, FDA-cleared technology, MaxCyte avoids these challenges to cell loading and provides an approach that dramatically accelerates clinical development timelines by avoiding toxicity, reproductive toxicity and carcinogenicity studies due to its inherent simplicity and safety. As an example, one MaxCyte partner was able to submit an IND at least six months earlier than anticipated utilizing alternative methods.
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