PanTHERA CryoSolutions had the opportunity to sit down with David Lewandowski, presently Director of Business Development, at AmplifyBio, to chat about the some of the challenges the cell therapy space faces and the emerging key enabling technologies.
Photo credits to PR Newswire
David Lewandowski has many years of leadership experience in the field of Advanced Therapies. He has been instrumental in bringing together this community and its thought leaders to tackle the challenge of safely and effectively transporting critical starting materials and advance therapies from the point of manufacturing to the point of care.
David is a member of the Leadership Advisory Council for the Advanced Regenerative Manufacturing Institute (ARMI), Past President of the International Society for Biological & Environmental Repositories (ISBER) and serves on working groups to advance cryopreservation and cold chain distribution with the Standards Coordinating Body for Regenerative Medicine (SCB) and International Society for Cell & Gene Therapy (ISCT).
David has held various leadership and business development positions with Azenta Life Sciences, Cryobiosystems and Genentech.
Thank you David for meeting us today! Could you please give us a quick introduction of yourself?
I have been in life sciences my whole career. It’s been exciting because seeing how the industry grew, and along the way, learned about cryobiology through working with biobanking, and spearheading the development of the ISBERG Cryogenic Storage Facility Best Practices document. This document was developed with the expectation of helping people who are working with cryogenic temperatures, to ensure that they have made the necessary checks concerning the products and being safe throughout the process. I have supported a range of organizations and research groups, beginning in the discovery phase, all the way through manufacturing and the distribution of cell therapies, in terms of handling cryogenic temperatures, which carries a lot of risks, and because cell and gene therapy products are being transported from one place to another and changing hands so many times in the manufacturing process.
Documentation in the cell and gene therapy world can come in different ways. Whether it is for personnel, or for equipment, or having the right software programs. It is matter of trying to understand how products can be implemented to make the processes easier. But cryogenic storage has not been the easiest task to execute. Having seen so many different programs and being in this particular industry for so long, the workflows and the bottlenecks and the challenges that people have with scaling advanced therapies, is definitely an area that needs to be tackled.
Interesting! Can you share with us some of the challenges that the cell and gene therapy industry face?
I think there’s probably three outstanding challenges. The first challenge is the knowledge and understanding of cryogenic temperatures, and what these mean in terms of how they are able to protect their products. People have always assumed that the freezing process/aspect is very easy. Because once its frozen, its frozen. However there have been research groups such as the Society for Cryobiology which have demonstrated that there is a science behind freezing and that it is much more important to pay attention to the process of freezing, which can be a make or break to research projects or potential life-saving therapies.
The second challenge is around workforce development. Workforce development has been a challenge that we’ve seen in the biobanking industry for several years. When you have a collection with such high value, they need to be cataloged and organized in a specific way so that they can be easily found, tracked, and used appropriately over time. It involves freezers full of vials, donning the PPE equipment and tracking them. It is a great way, in my opinion to get into the industry and the workforce but it is not a job where people are spending their entire careers on. So, the turnover rate is high, and there is a need in the industry to nurture researchers and talent in this industry.
The last challenge is the tracking of transient warming events. It is easy to track the temperature of a product when it is in the freezers, or shipping containers with the newer technologies that are always available with location and temperature tracking. It is easy to track the product in a stable environment. But what happens when the product is received, or transferred from the shipping container to a freezer or vice versa? There are many instances where the product is moving through ambient air and these instances, can impact the product very quickly, more quickly than what most people think. This aspect of transient warming however, is not well tracked or researched.
And why do you think at this point, there has not been much research or tracking done on transient warming events?
There has been research done, in posters and papers but not nearly as robust. It would be great to gather a small group of experts to do a larger scale review of transient warming events. I think the biggest barrier/challenge to this is that everybody’s product is a little bit different, and it is hard to present the data when the nature of the products is not the same.
Are there any significant key enabling technologies that you feel are emerging?
I would say, on more general terms, I think that some of the barcoding and RFID technologies that are emerging could make a difference for tracking at cold temperatures and ensuring that you have the right product. Another one will be automated storage. With collections getting larger and larger, automated storage will make sense when you can get more data concerning the collection, such as where was the product, who touched it, when was it touched and at what temperature. Onboard inventory management can make a huge difference when everything is tracked and accessible in real time.
Also turning our lens on PanTHERA and the novel Ice Recrystallization Inhibitors (IRIs), and how it is giving that cushion to the products when it comes to transient warming events, can make the difference. We know a major cause of cell death is recrystallization and that can occur during transient warming. If left out long enough, the product can become unstable. By focusing on the transient warming events, and giving the products that cushion, can improve the likelihood of success.
And while transient warming events and how to reduce the effects of transient warming has been getting more attention than it has in the past, we still have a lot of work to do.
This conversation has been edited for brevity and clarity.
About PanTHERA CryoSolutions
PanTHERA CryoSolutions is a Canadian corporation that designs and manufactures cryopreservation solutions for cells, tissues and organs for research and clinical markets. Our patented ice recrystallization inhibitor (IRI) technology exceeds other products by providing superior cryopreservation and increasing post-thaw cell recovery and function for our customers. The technology enables the use of significantly less costly storage and transportation systems limiting the need for liquid nitrogen use for some cell therapy applications
