GMP-compliant Data Management for Advanced Therapies
Advanced therapies are revolutionising the way we treat cancer
Advanced therapies, or cell-, gene- and immunotherapies are revolutionizing the way we treat cancer.For example, have a look at Kymriah, a groundbreaking leukaemia treatment involving the genetic enhancement of the patient’s own immune cells. These novel treatments provide hope for many diseases for which there are currently no real cures, such as arthritis, multiple sclerosis, Crohn’s disease, diabetes, etc. However, the complex production processes and the stringent regulatory landscape for advances therapies are a significant hurdle for the widespread availability of these therapies to patients in need.
Variable production processes
The production process of advanced therapies are extremely challenging. Most of these therapies are ‘autologous’, meaning that the patient himself is also the donor of the biological material that is used to make the therapeutic product. The first step is to source the starting material from the patient. This material is then processed via a chain of unit operations, which can include complex tasks like gene transfers and cell expansion steps, to yield the final biological product.
Since the batch size is small (i.e. often equal to 1) and the field is still developing, many of these unit operations rely significantly on manual input from a cleanroom operator or lab technician.
As a result of the starting material that is not perfectly controlled because of the inherent biological variability between donors, and the (semi-)manual process steps that introduce operator-induced variability, the manufacturing of advanced therapies cannot be completely standardised.
Stringent regulatory landscape
Notwithstanding this variability, the production processes of advanced therapies need to comply with the same stringent regulations as other medicines, for example Good Manufacturing Practices (GMP). The goal of GMP is to maximally ensure the quality and safety of a medicinal product. The manufacturing processes therefore require extensive record keeping, process validation, report generation and personnel qualifications. You can imagine that combining variability with stringent regulation is a challenging endeavour for any manufacturer of advanced therapies.
Tsunami of paperwork
In practice the reconciliation between variability and regulation is unfortunately often based on numerous record keeping tasks for scheduling the processes, executing the processes (i.e. the batch record), logging the process data and preparing the release documentation with all the required QC/QA reports.
These record keeping tasks require many different departments to collaborate. Additionally, records pass from person to person multiple times, which complicates the data management even more.
The personalised nature of most advanced therapies require that this paperwork is done for every single patient. This means that, contrary to classical medicines, it is hard to achieve ‘economies of scale’ since 1 batch can only be used to treat a single patient. The data acquisition, management and reporting therefore quickly becomes a burden for the manufacturers of advanced therapies. In order to ensure efficient data management that actively assists in the regulatory compliance of the manufacturer, integrated software platforms are needed that are able to handle the (biological) variability in the processes.
Figure 1: The data management challenge for advanced therapies consists of a non-stop tsunami of paper-based processes that require multiple handovers between many different departments and data management tools.
Toon Lambrechts, Co-founder and CEO at MyCellHub
MyCellHub is committed to the complete digitalisation of manufacturing workflows for advanced therapies. The software platform streamlines the data management and analysis of GMP-compliant workflows in order to minimise operator errors, reduce the reporting burden and bring down the production costs of advanced therapies. Additionally, the platform enables advanced data analytics to gain valuable insights for process optimisation.
The MyCellHub platform consists of 2 parts:
- A tablet application specially designed for use in cleanroom and laboratory environments. This application provides interactive work instructions to the cleanroom operator on how to execute the operations. The tablet app and work instructions are designed in a way that the process variability can be reduced as much as possible. At the same time, the tablet application collects all process information in real time and transforms this information into the batch record automatically.
- A browser application that centralises all collected data. The data from the cleanroom is centralised in a database that is accessible to the user via a web interface in a standard browser. In this interface operators and managers can automatically generate process reports, consult product inventory levels, generate data analyses and plots,…
The software provides an integrated tool for bioprocess tracking and helps manufacturers of advanced therapies comply with relevant regulations.
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