OUR SOLUTIONS
AiCella InsightsTM Dashboard
We provide a web-based dashboard and process design “toolkit” with “ChatGPT” like functionality that incorporates analysis of process data to determine critical parameters for CAR-T based therapy development, avoid bottlenecks, and ultimately connect patient clinical responses to key process parameters; The tool will allow visualization of the most impactful process parameters using each of the seven AI algorithms in a user-friendly interface. In addition, the interface will provide the option to perform simulations to further understand how changes to process parameters can potentially impact patient responses.
Wet-lab verification of AI generated process recommendations
AiCella leverages cutting-edge artificial intelligence (AI) technology to generate process recommendations for cell therapy development. We don’t stop at AI-generated insights; we validate these recommendations through rigorous wet-lab verification. Our hands-on approach ensures that AI-driven strategies translate into real-world, reproducible results.
SOPs with recommended best practices
AiCella provides Standard Operating Procedures (SOPs) that encompass recommended best practices for every aspect of cell therapy process development. These meticulously crafted SOPs serve as a guide for your team, facilitating the implementation of optimized processes while maintaining consistency and compliance.
Tech transfer assistance to CDMOs
We understand the importance of seamless technology transfer when transitioning from development to manufacturing or scaling up production. AiCella offers comprehensive tech transfer support, ensuring that your cell therapy processes are successfully transferred to CDMOs, guaranteeing a smooth transition, and maintaining process integrity.
IND filing support
Preparing and submitting an IND application to regulatory authorities is a critical step in advancing cell therapies for cancer treatment. The team at AiCella is experienced with regulatory submissions and provides extensive support in preparing your IND filing, including documentation, data compilation, and regulatory strategy guidance. We work closely with you to ensure your submission meets regulatory requirements and increases your chances of approval.
IP filing support based on InsightsTM-driven elucidation of process development
Our AI outputs generate a computer file of process data that can be used to support intellectual property filings, which is important for companies wishing to protect these critical information.
cGMP-oriented process development
AiCella specializes in the development of cell therapy processes that adhere to Current Good Manufacturing Practices (cGMP) standards. Our team of experts ensures that every step of the process is designed and optimized to meet regulatory requirements, ensuring the safety and quality of cell therapies intended for cancer treatment.
