Isolere Bio Team Readies for Oral Presentation, Poster and Exhibit Booth at ASGCT 2025
The Isolere Bio team is excited to announce our attendance at ASGCT's 28th Annual Meeting next month in New Orleans! We’re also excited to announce that both of our abstracts were accepted; one for an oral presentation and one for a poster presentation! If you’re planning to be in New Orleans for ASGCT 2025, here are a few of the ways that you can find us:
Sponsor Booth # 1848
All Week
Drop by and chat with the team in-person at Booth #1848!
Led by our Business Development Manager, Ashley Wilson, and Field Application Specialist, Tori Robinson, we will be walking individuals through our IsoTag™ Regent technology, answering your questions, and handing out some fun giveaways. Be sure to stop by or schedule a specific time to meet with the team.
Jennifer Haley,
Associate Director, Applications Development
Will be presenting:
Neutral pH Elution of AAV using Affinity Liquid Phase Separation (ALPS) in Centrifugation and Tangential Flow Filtration (TFF) Formats for Flexible Downstream Processing
Session Title: Downstream Manufacturing for AAV Vectors
Date: Thursday, May 15, 2025
Time: 2:15 PM - 2:30 PM Central Time
Room: NOLA Theater C
The purification of adeno-associated virus (AAV) using Affinity Liquid Phase Separation (ALPS) introduces a novel method that challenges traditional gene therapy production paradigms. The IsoTag™ AAV reagent combines an affinity ligand with a stimulus responsive, phase separating biopolymer to purify AAV based on size and affinity in a single process without chromatography. The ALPS process was implemented in a centrifugation format to screen binding and elution conditions for AAV9 in parallel, utilizing only 1mL of harvest per condition. This screen identified a neutral pH elution buffer that allows for >90% recovery of AAV9, comparable to results achieved with a standard pH 3.0 elution. This elution buffer was tested in a tangential flow filtration (TFF) setup utilizing hollow fiber filters, demonstrating centrifugation screening results were translatable to scalable ALPS-TFF process. The ALPS TFF process developed at the 1L scale was then scaled to 2L and 16L by maintaining a constant filter loading, shear rate and flux for viral genome capture and recovery >95% by ITR2 qPCR in less than 4 hours for all three scales. Finally, an ALPS-TFF process was developed using flat sheet cassette format with externally validated data, demonstrating flexibility of the IsoTag™ AAV ALPS technology for AAV affinity purification. The IsoTag™ AAV reagent allows for neutral pH elution of AAV in a high throughput centrifugation format as well as scalable TFF processes to address a wide range of AAV affinity purification applications.
Authors: Jennifer Haley, Sophia Petraki, Chris Ocker, Jarrett Dobbins, Kimberly Anderson
If you are not able to attend, learn more about how IsoTag™ AAV Reagent helps concentrate and purify AAV in under 4 hours without the use of affinity chromatography.
Sydney Bear, Scientist
Will be presenting:
Combining Fixed Bed Bioreactor and Liquid-Phase Affinity Purification Technologies for Next-Generation, Low-Cost Lentiviral Manufacturing
Session Title: Thursday Poster Reception
Date: Thursday, May 15, 2025
Time: 5:30 PM - 7:00 PM
Room: Poster Hall I2
Manufacturing lentiviral vectors (LVVs) presents significant challenges due to their complex production process and stringent safety requirements. The delicate nature of these viral vectors demands precise conditions for cultivation and multiple, low-efficiency purification steps, often leading to low yields and high costs. Additionally, ensuring consistent quality and functionality while adhering to rigorous regulatory standards adds further complexity to the LVV manufacturing pipeline. Despite these difficulties, LVVs are invaluable tools in gene therapy and biomedical research, as evidenced by the approval of several lentiviral-based therapeutics with significant clinical benefits, albeit with high drug costs impairing broad adoption. Here, we combine flagship technologies from Isolere Bio and Univercells Technologies to remedy the inefficiencies found throughout LVV manufacturing and drive down costs significantly.
Univercells Technologies scale-X™ fixed-bed bioreactor technology has demonstrated high yields of infectious LVV production in batch and perfusion mode from R&D to commercial scale. The structured fixed-bed within the scale-X bioreactor enables high-density cell culture within a small footprint. LVV production with the scale-X bioreactor achieves upstream titers comparable or up to 3-fold higher than standard flask process and up to 10-fold higher than competing bioreactor technologies. Viral molecules produced in scale-X have also shown to contain up to 10x lower host cell protein and DNA levels compared with traditional methods, potentially simplifying clarification and downstream steps.
Isolere Bio’s IsoTag™ LV affinity reagent enables non-chromatographic purification of lentiviral vectors with high recoveries and purity, minimal unit operations, and total processing time under 8 hours. Traditional downstream processing requires multiple steps – typically a TFF, AEX, and SEC, with LVV losses seen at each stage. With IsoTag LV that is reduced to a single TFF operation due to the on-command droplet forming technology. LVVs are sequestered into highly pure, reversable droplets and quickly purified using microfiltration via TFF. With this process, LVV is concentrated 100X with 30% functional recovery and > 2 LRV of host cell proteins and DNA.
In this study, for the first time, we combined the two complementary technologies to both produce and purify high quality LVV at half the cost of traditional processes, while decreasing total manufacturing time by one week, and halving the required amount of consumables. Only two pieces of equipment (scale-X bioreactor and TFF) were required to manufacture LVV from start to finish in a proof-of-concept study. We were able to blend these upstream and downstream technologies and add IsoTag LV directly into the scale-X bioreactor, streamlining processing. Importantly, due to minimal purity requirements for the IsoTag process, we were able to remove the nuclease treatment and clarification steps. This did not impact purification performance nor the purity profiles in the final product.
In conclusion, by pairing disruptive upstream and downstream technologies, we demonstrate the possibility of redefining lentiviral vector manufacturing in a simplified, low-cost workflow. We expect this novel approach to facilitate the production of more accessible cell and gene therapies worldwide.
Authors: Sydney Bear, Mauri Belasko, Thomas Robert, PhD, Sheldon Doxilly, Nikki Votaw, PhD
If you’d like to learn more, explore our resources on IsoTag™ LV Reagent now!