Scaling Cell and Gene Therapies Through Automation

By Andrew Stone, Reuters

Delivering on the promise of cell and gene therapies requires significant process improvements to cut manufacturing time and costs

Automate data capture and build the capabilities to leverage it

Automating data capture is a vital part of the improvement journey in CGT. Paperless plants with end-to-end chain of custody are going to be essential to efficient scale-up.

The importance of being able to capture detailed data on critical process parameters from highly integrated processes, starting at R&D and ending in manufacture, is vital so that no data or knowledge is lost.

“Everyone is realising that capturing data at the source is important. You have got to capture data electronically,” says Jeet Sarkar, Vice President and Head of IT at the Center for Breakthrough Medicines. “You cannot serve the patient well without those processes.

“To continuously innovate, to scale up, you need this data available. By constantly monitoring you are reducing errors, making your processes more efficient. Over time you will have the data to understand which batches are going well. Getting to right batch, first time, every time is vital.”

A new generation of ‘plug and play’ manufacturing equipment from active chromatography systems, automated cell culture systems and suspension bioreactors has been built to supply the real-time data required for this end-to-end monitoring and data analysis.

A further key to innovation and driving down costs for the industry will be building the data science teams with the statistical modeling skills to leverage these machines’ ability to gather data in real time.

This essential requirement may be one of the key drivers of outsourcing, Sarkar suggests. More data will drive greater efficiencies and speed of scaleup, which will become core strengths for CMOs, leaving therapy developers to focus on research.

Learning from each other Most development work in CGT is happening in silos but the potential for different players to learn from each other is great. ASC is part of the 20-strong NIH and FDA-led Bespoke Gene Therapy Consortium (BGTC) consortium convened to find ways to share knowledge and experience on improving and streamlining the entire process.

Despite the routes to improvement outlined above, a significant barrier remains: regulation. A particular source of friction slowing the speed of improvements is the regulators’ bandwidth to keep up with new and innovative process improvements that are taking place in real time today. The task of evaluating emerging technology to ensure patient safety is of course essential but as currently configured the regulatory process requires the pioneers to take big risks up front and hope for approval at the tail end of their investment decisions.

CBM is a cell and gene therapy contract development, manufacturing, and testing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

Co-locating manufacturing, process development and analytical services prevents delays and handling errors. Our purpose built 700,000 sq. ft. manufacturing center is future-proofed in terms of infrastructure within and around the site. The current facility sits on over 1 million sq. ft. of space, allowing for future expansion to match the growing demand of the cell and gene therapy industry. Internally, the suites have been designed so that complementary services and labs are adjacent or nearby, to ensure we can accelerate time to market without compromising quality.