Why cell &gene C(D)MOs benefit from digitalization

The cell & gene therapy industry (CGT) is growing at a staggering 30% CAGR and is estimated to reach $14B by 2025. At the same time, search for talent and laboratory capacity is getting harder. Thus, more and more CGT companies rely on Contract Development Manufacturing Organizations (CDMO) for manufacturing with adherence to stringent regulatory cGMP conditions.

CGT manufacturing for both autologous (patient to patient) and allogenic (donor or cell bank to patient) treatments face difficult issues such as a complex supply chain, strict traceability conditions, variability on patient and cellular level and a tight scheduling of the batch disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for the critically ill patients.

Electronic batch recording is vital

CGT companies are emerging from years of laboratory scale development through preclinical tests and pivotal clinical trials to ultimately reaching FDA approval and product commercialization. Digital solutions such as a robust Electronic Batch Recording system (EBR) become vital.

The guidelines on Advanced Therapy Medicinal Products (ATMP) by EMA as well as on CGT by FDA dictate donor and recipient identification of the cells over the complete manufacturing process to ensure treatment of the patient with the correct cells, as mistakes in this aspect can have devastating effects. EBR enables the identification of the material at any point in time and in relation to used equipment or locations, facilitating drastically the ATMP/CGT compliant procedure. Given that the raw material for these processes are actual patient cells extracted in a clinic, a failed batch is devastating and could mean loss of a patient’s life. A failed batch due to poor paper record handling must be avoided at all costs.

A crucial component in reducing Cost of Goods Sold (COGS) in developing CGT therapies is through increased efficiency of the manufacturing process. Automation provides a suitable option to address this challenge. Manufacturers who have become early adopters of digitalization, automation and continuous improvement are reaping huge benefits. They have minimized the use of paper, automatized calculations and sped the design of manufacturing batch records. What’s more, they have reduced cGMP deviations and more quickly released manufacturing batches based on review by exception, which aligns with right first time initiatives. Especially the manufacturing of cells that are delivered fresh to the hospital for treatment results in time-critical batch release and supply chain prerequisites that can only be met by digital collection of all required data.

Automated processes are a good starting point

CGT manufacturers rate manufacturing process stability and scalability as their top two considerations throughout clinical trials. They equally rank process variability, scale-up ease and reduced cycle time as motivation for automating both their manufacturing processes and supply chain. In this vein, a CDMO/CMO that already has a fully digital facility with EBR capability can help achieve these goals.

The detrimental impact of Covid-19 has challenged CGT sponsors with a stoppage of clinical trials and supply chain hurdles. In the manufacturing domain, both in-house and contract manufacturers have implemented strict guidelines to ensure employee safety. Manufacturers, who had embraced digitalization, quickly rebounded to get systems back online to meet delivery deadlines. In addition, automation facilitated the process as fewer hands touched the process or final product, thereby drastically reducing risk for contamination and the amount of four-eyes-principle steps.

Cell therapy sponsors select CDMOs

CGT sponsors have two options for how to manufacture: build an internal manufacturing capability or employ a CDMO/CMO. Investing in their own manufacturing facility would develop internal expertise, optimize processes, control manufacturing capacity, and potentially save money in the long run, if the drug commercializes.

However, utilizing CDMOs/CMOs can help provide flexibility in capacity planning, reduce commitments to evolving technology platforms, and reduce initial investments. CDMOs/CMOs have existing cGMP facilities designed to comply with regulatory authorities. More importantly, they have a skilled workforce who can execute the process, manufacture the product and deliver it to hospitals and clinics. Some CGT sponsors employ a regional manufacturing model and use CDMOs/CMOs to manufacture their products in various geographical regions. Concurrently, smaller scale sponsors are utilizing co-working or collaborative spaces such as The Center for Breakthrough Innovation (King of Prussia, PA, USA) and the Cell and Gene Catapult (Stevenage, UK) for meeting their development and manufacturing needs.

Digitalization improves efficiency and reduces risk for errors

Sponsors’ demands are growing and complex, which have many CDMOs/CMOs pushing to become leaner and digital. EBR solutions ensure being agile enough to meet sponsor requirements of patient delivery deadlines and frequent schedule changes. Digital data are easily accessible with digital systems automatically tracking updates to the process.

Given the volume of different manufacturing processes in the CGT space, CDMOs/CMOs must continuously manage customers’ work instructions and Standard Operating Procedures (SOPs) which change regularly. Operator training, manufacturing recipes and product specifications also vary and need to be updated frequently. Digital systems provide operator guidance through the updated processes, reducing the training effort and the risk for errors drastically.

With cloud-hosted digital EBR solutions, CGT companies can even better focus on their core business while leaving the application and infrastructure support to the supplier. IT responsibility can thus being reduced by 75 %. Upfront investment can be decreased by up to 65 %, with minimized costs for deployment and operations.

In conclusion, digitalization is a huge facilitator for CDMOs/CMOs.

A cloud-hosted digital EBR solution coupled with a flexible scheduling solution and integration to other supply chain and IT systems is the “need of the hour” today. With an EBR, ATMP/CGT sponsors can monitor the CDMO/CMO process right from their desk. The most important compliance parameters of chain of identity, chain of custody, chain of condition and limited time horizon for critically ill patients can be monitored right at one’s fingertips. Any events, delays or changes can be addressed immediately.

With some upfront initial effort, CDMOs/CMOs will save a lot of effort downstream when data is integrated across the enterprise and quality and production teams are relieved of an enormous documentation burden. CGT companies who have adopted EBR have reported an 83% decrease in data input errors and more than 87% decrease in review time after production completes by embracing the review by exception paradigm.

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