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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Accelerating advancement in gene therapy by improving downstream purification of viral vectors

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Significant advances have been made in the area of gene therapy where the adeno associated virus (AAV) sub-classes have emerged as the vector of choice for many of these therapies due to improved safety and efficacy. While the majority of AAV-based gene therapies are still in early and mid-phase, large scale manufacturing platform technologies including downstream purification are a challenge the field faces to meet market demands.

Traditional purification methods for viral vector manufacturing usually involve multiple steps of chromatography, such as ion exchange and hydrophobic interaction, which leads to cumulative yield loss and ultimately increased cost. Density ultra-centrifugation can also be utilized, however the complexity of scale up significantly limits the use of this method downstream. Recent advancements in AAV affinity chromatography have significantly improved the process for a number of AAV serotypes, but a major hurdle still, was the lack of an industrialized platform to consistently purify AAV vectors at large scale. With the development of the pan-tropic AAV affinity resin, POROS™ CaptureSelect™ AAVX, this need got fulfilled.

During this presentation we outline the benefits of implementing affinity chromatography as a platform in the downstream purification of viral vectors, using the CaptureSelect™ technology as the basis of generating high-binding affinity ligands. The data presented will reveal the benefits of affinity chromatography related to specificity, capacity, process yields as well as process scalability and flexibility for the purification of a broad range of AAV serotypes. The utilization of these resins has demonstrated to be a significant improvement to the downstream process of AAV viral vectors, by reducing the number of purification steps and maximizing productivity, offering scalability and process consistency.


Orjana Terova, Senior Product Manager, Bioproduction Division,Thermo Fisher Scientific

Orjana Terova is Senior Product Manager for Purification products within the Bioproduction Division at Thermo Fisher Scientific. Orjana has a M.S. in Chemistry from University of New Hampshire (in 2008). She also has 11 years of industrial experience at Thermo Fisher Scientific. Her expertise includes a strong technical background in small molecule and bead chemistries, new product development and commercialization. In her current role Orjana is responsible for managing globally the POROS Chromatography product line, including life cycle product management, implementing programs to drive business growth strategy and support of the global sales organization.


Dr Hetal Brahmbhatt, Principal Investigator, Viral Vector Services, Thermo Fisher Scientific

Dr. Hetal Brahmbhatt is a Principal Investigator in the Science and Technology Team, Pharma Services, Viral Vector Services at Thermo Fisher Scientific. She has a PhD in Biochemistry and Biomedical Sciences from McMaster University where she characterized small molecule modulators of apoptotic proteins. In her previous role at Thermo Fisher Scientific (former Brammer Bio), she developed and established downstream purification processes for clinical manufacturing of several gene therapy viral vectors. In her present role, she contributes to the development of platform processes and technologies for the manufacturing of viral gene transfer vectors.

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