The quality of starting materials can have an enormous impact on the potency, purity, and safety of a cell therapy product. Flaws in the collection or transportation methods used can adversely impact the ability of a final product to meet its quality target product profile (QTPP), which may impede the successful commercialization of a cell therapy product.
Joseph Vitale, PhD, Director of Account Management at Hitachi Chemical recently participated in a panel alongside Amy Hines, BSN, RN, Director of Collection Network Management for Be The Match BioTherapies, Richard Smith, New Business Development Consultant for Be The Match BioTherapies, and Sanjin Zvonić, PhD, Vice President of Process Science & Manufacturing at WindMIL Therapeutics.
During this panel discussion, these four cell therapy experts discussed:
The importance of high-quality starting material for the success of new cell and gene therapies;
Challenges associated with cell collection and the resource burdens currently impacting collection infrastructure;
The need for standardized cell collection processes to obtain consistent, compliant, and high-quality starting materials;
Proven strategies for the effective and efficient qualification and onboarding of collection sites; and
Efficiencies that can be gained by leveraging partners with established relationships in the apheresis and collection environment.
Here are a few highlights from the webinar, which can be accessed on the BioInsights website:
Effective Training is Critical to Consistent Cell Collection
One of the first things that Elisa Manzotti, CEO/founder of BioInsights and the webinar’s moderator, mentions in the introduction of the discussion is that, “The success of a cell or gene therapy really depends on the collection of high-quality starting material—which in turn relies heavily on apheresis and collection professionals receiving applicable, highly-specialized training.” Without the right training, the staff managing the starting material collection process may not be able to effectively follow safe and effective collection methods.
The on-boarding process for collection sites may play a critical role in ensuring that collection personnel have received such training. As noted by Amy Hines in her presentation:
“Developing and managing our network relies on several factors: we need to understand the collection network environment, we constantly advocate and consistently provide support for collection sites, we maintain open channels of communication, we provide onsite support to collection sites as needed, and we facilitate knowledge sharing among sites following the same collection protocols.”
This support goes beyond simply providing one-off training to collection staff. Instead, Amy Hines (and Be The Match), recommends providing continuous learning and support to ensure that collection practices stay compliant with process specifications.
No Two Apheresis Centers Are Exactly the Same
In her presentation, Amy Hines notes that different collection sites may have different internal processes for managing collected cells, which will impact the journey of the cells. She states, “If you know one apheresis center, you know one apheresis center.” The onboarding process for a new starting material collection site needs to account for this fact.
For example, some collection centers may require that starting materials be subjected to onsite testing before being moved out, while others may not. Accounting for these types of differences is crucial for ensuring that the quality and viability of starting materials is not impacted by them.
Collection Processes Often Need to Be “Personalized”
During the Q & A portion of the webinar, Joseph Vitale discusses how the variability of starting materials and indications impacts the collection process:
“Being able to have good control at the clinical sites—it’s more than just having standard kind of apheresis or bone marrow collection procedures. On the apheresis end, they also have to be personalized, in a manner, to the indication that you’re treating… the more variable the incoming product, the more complex the manufacturing process gets. And, that’s a major issue with the industry—which I believe to be the only industry in the world where your starting raw material is variable.”
Achieving “Personalization” of processes remains a major challenge, however, due to the potential differences in starting materials.
Clarifying what is wanted from the starting material—which may vary based on the indication being treated—is crucial for ensuring efficacy. Richard Smith, when asked about his experience in dealing with variable source material quality, stated that one major concern was for apheresis professionals to have “Concise and clear protocols defining what is wanted and what is not wanted in the product… anything that can be done to clarify what is wanted and what is targeted is going to be important.”
Standardizing of Apheresis Processes is the Key to Scaling Cell Therapy Manufacturing
In a patient-specific cell therapy manufacturing process, it is effectively impossible to achieve ROI improvements by simply scaling up production—each therapeutic cell treatment has to be manufactured on a 1:1 basis. Making more doses per patient is a waste of materials and resources. Due to this, standardization helps to make costs more predictable and controllable. This is crucial for achieving long-term commercial success with a patient-specific cell therapy product. However, it is also important for patients. As Amy Hines mentioned, “It’s the patients that win when we’re able to come up with standards that improve quality—that improve efficiency that bring these therapies to the bedside much more quickly and safely.”
To watch the completed webinar, fill out the form on the BioInsights website. For more information and insights into cell therapy manufacturing and how to achieve long-term commercial manufacturing success, reach out to our team today.
PCT TeamOur leaders have worked on some of the major cell therapies of the past 10 years, and have extensive experience in pharmaceutical-grade quality and operations.
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