Cell & Gene Therapy
Digital Intelligence for Advanced Therapies
In cell and gene therapy, the operator is the process. Highly manual workflows, small batch sizes, and zero tolerance for contamination place exceptional demands on every individual involved.
We help CGT teams meet those demands. By transforming critical process knowledge into structured models, objective risk assessments, and targeted training that builds consistent, confident performance.
Trusted by the industry
Cell and gene therapy manufacturing is among the most complex environments in aseptic production.
We support these highly manual, patient-specific workflows with data-driven process understanding.
Operator-Centered Process Design & Training
Risk Assessment & Control
Reproducible Quality Standards
Interested in data-driven process intelligence for cell and gene therapy?
Contact us to learn how we can assist you.
Solutions by Use Case
What the industry says about us
“Through the integration of expert insights, regulatory requirements, VR technology and risk profiling data into our course content, we aim to establish a data-driven approach to training by leveraging these resources.” Read more: Press Release 19 June, 2023
“Normally, there is a certain subjectivity in training. With the Simulator the judgement on mistakes is transparent, and reproducible.”
“The virtual reality environment of the Simulator allows our operators to make mistakes, see consequences and learn from them.”
“In critical aseptic environments, employee qualification is crucial. Innerspace provides the effective training package that complements our program.”
“Since the start of our collaboration 5 years ago, Innerspace made enormous progress in establishing outstanding training tools.”
“I have integrated the VR Simulator at a customers site into an existing training program and was amazed by how easy and fast this project was going.”
“We are thrilled to partner with Innerspace to provide our members and the industry with innovative and effective training solutions that brings the VR cleanroom into any location.” Read more: Press Release 19 June, 2023
FAQ’s
CGT processes are highly manual and involve biological materials where contamination has direct consequences for patient safety, making standardized, structured risk assessment essential. Innerspace addresses this by systematically modeling critical interactions and embedding contamination risk logic directly into process design, documentation, and training.
Reproducibility in CGT depends on consistent operator behavior and a shared understanding of critical process steps, not just documented procedures. Innerspace uses Frame-by-Frame® to build structured process models that capture the underlying logic of each critical interaction. This creates a reliable, reusable foundation that supports reproducible execution even as processes evolve or scale.
Manual processes in CGT leave significant room for variability and human error. Frame-by-Frame® deconstructs each critical step into discrete, observable interactions. Making contamination risks visible, assessable, and trainable before they reach the cleanroom. This allows teams to proactively address risk rather than react to deviations after they occur.
Regulatory frameworks for CGT place strong emphasis on contamination control strategies, process understanding, and operator competence. This includes EudraLex Volume 4 as well as emerging advanced therapy guidelines. Innerspace directly addresses all three by modeling human-environment interactions with scientific objectivity and generating structured, traceable documentation. The result is audit-ready evidence grounded in actual process intelligence, not procedural intent alone.
We’d love to hear from you
Fill out the form, and one of our experts will get back to you shortly. Whether you have a question or need assistance, we’re here to help.