Controlling quality and variability in drug manufacturing is essential to the safety and efficacy of pharmaceutical products. In biomanufacturing, increased adoption of automated systems is helping to facilitate these tasks while standardizing production. By using automation to minimize human interaction and time and resource requirements, you can increase your product’s speed to market and mitigate many of the risks and costs associated with commercialization.
These innovative solutions improve manufacturing efficiency and support rapidly growing industry sectors, such as cell therapy. Cell therapies have burst onto the market with great promise to improve patient treatment options and alter clinical care. With the cell therapy market expected to reach over $8.8 billion by 20271, digitizing operations while keeping pace with this emerging space can prove challenging. To safely meet increasing demand, we need to reexamine how best to apply automated solutions.
Chronicle™ automation software by Cytiva is a purpose-built manufacturing execution system (MES) designed and verified for cell therapy manufacturing. Chronicle software accounts for the special considerations needed when working with these unique, highly personalized products. Automation experts face unfamiliar challenges in integrating these types of tools, as setting up a facility for cell therapy manufacturing is significantly different than doing so for traditional biomanufacturing.
Below are six common misconceptions that can potentially hinder the successful execution of an MES for cell therapy.
1. Implementing an MES requires a significant up-front investment.
The costs associated with configuring a general-purpose MES to meet the needs of the cell therapy industry can be significant. This is due to the time and expertise required for configuration and validation, as well as heavy up-front licensing fees.
A purpose-built system already configured for cell therapy manufacturing can lower these up-front costs, especially if a pay-per-use model is utilized. Similar to how cloud computing services and technologies replaced the need for traditional data centers, a pay-per-use MES would allow you to pay based on how many batches you intend to process, from just one at a small scale to many at a larger scale. This gives you the opportunity to utilize the system as you grow, providing flexibility in a rapidly expanding market.
2. I need someone to do the digital conversion from paper to electronic standard operating procedures for me.
Converting from paper to electronic standard operating procedures (eSOPs) for a drug development process offers numerous benefits and can be facilitated independently, with the proper tools. However, there is a major difference between simply entering data into a computer system for storage and management versus taking the step toward implementing an automated solution for added efficiency and flexibility. The latter might be intimidating to bioprocessing experts who have never relied on this type of technology, leading them to believe that bringing in a third-party consultant is necessary.
A user-friendly automation software that includes templates for building eSOPs and can easily integrate instruments popular in cell therapy facilitates simplifies this otherwise overwhelming task. And, most importantly, this unified platform empowers experts who understand the processes best to fine tune operations and maximize control and efficiency.
3. MES software needs to be GAMP Category 4.
The GAMP™ guidelines for ensuring pharmaceutical software is appropriate for use include five categories that outline validating and testing requirements. The vast differences between traditional bioprocessing and cell therapy manufacturing can sometimes lead manufacturers to believe they need an MES that is GAMP Category 4.
GAMP Category 4 means the MES must be configured to meet the needs of this growing market and comes with a significant amount of work, including configuring the software to ensure it meets your specific needs, building extensive user requirement specifications, creating documentation to verify functionality, and investing in the necessary resources for validation. You would need a knowledgeable team with experience in cell therapy to complete these activities; however, using a GAMP Category 3 software that is already configured for cell therapy eliminates these steps, saving considerable amounts of resources and time.
4. The MES needs to monitor only what happens inside the factory.
In traditional bioprocessing, an MES is used to track and document raw materials throughout the manufacturing process until they come together in the final product. With the personalized nature of cell therapy, the collection of patient cells ― or raw materials ― often takes place at the patient’s bedside, not at a manufacturing facility. The cells are then cryogenically preserved for transport, requiring an MES that can monitor, control, track, and document the chain of custody.
An MES for cell therapy can provide hospital personnel with eSOPs outlining how to extract patient material and pack it into a shipper (possibly cryopreserving at the hospital) to be sent to the manufacturer. The therapy will go back into a shipper after it has been produced and cryopreserved at the manufacturing facility. The MES can then track the cryopreserved therapy back to the hospital to make sure it has not been mishandled or stored improperly. Lastly, the treatment is unpacked and thawed before patient administration. With a purpose-built MES overseeing this entire process, all critical data is accessible from beginning to end to help safeguard the chain of custody.
5. The hardest part of implementing an MES is configuring the software to implement our process and validating that configuration.
Configuring and validating a general-purpose MES for cell therapy manufacturing will likely present a major and costly challenge. Using an MES built specifically for cell therapy allows you to focus on the obstacle of implementing a new automated solution, including the subsequent adjustment to new business processes and workplace culture. This change cannot and will not happen overnight. Instead, change begins at the top with senior leadership doing everything they can to involve their staff in the transition. They should identify champions (those involved in the conversion) and celebrate early wins as demonstration that the system works. Identify the pain points within your organization and use those as a catalyst in transitioning towards an electronic system. As more success stories emerge, there will be a greater chance of organizations embracing MES implementation.
6. An MES implementation and the conversion from paper to digital must be done all at once with a single cutover date.
This misconception often goes hand in hand with the change in culture that is critical for the success of a new MES. If you force a single cutover date rather than giving your employees time to adjust to and accept the transition, you might set yourself up for failure before you even begin. Work as slowly as necessary through the process to avoid a major upheaval to your culture.
Cell therapy is a new frontier for many in this industry and adjusting to the difficult but exciting changes it brings will take some time. However, when done right, automation and MES implementation can put you at a significant advantage over your competitors, while also giving you the tools you need to produce cell therapies with the high level of safety and efficacy patients deserve and require.