Seminars & Webinars
2021
Presenter: Ivana Petrović Koshmak
Event: 2nd Annual Gene Therapy Analytical Development EU
Date: May 26, 2021
Abstract:
In-process analytics of vector capsid production is a critical optimization target in development of AAV-based gene therapy products. In this presentation we introduce a fast at-line HPLC based system that enables differentiation of vector capsid and empty capsid production in transfection mixtures. Case study results demonstrating the effects of different process variables on capsid production and assembly are shown and insights about purification are also discussed.
Attachments
Presenter: Aleš Štrancar
Event: Genetic Vaccine Development for Infectious Diseases Summit
Date: May 20, 2021
Abstract:
- Developments in gene therapy and threat of pandemics requests novel technologies to allow for efficient manufacturing of very large biomolecules and nanoparticles within short time.
- Convective Interaction Media with open channel structures resulting in no shear forces allows for fast and very efficient manufacturing of mRNA, pDNA, Adeno and other VLP based Covid vaccines.
- Ultra-sensitive DNA assay and fast in-process control using PATfix systems are introduced for production of safer Covid vaccines.
Attachments
Presenter: Aleš Štrancar
Event: ASGCT 24th Annual Meeting
Date: May 13, 2021
Abstract
Adeno associated virus (AAV) is the leading vector in the field of gene therapy because of its low toxicity, good overall safety profile, and ability to maintain stable expression for long periods of time. It is therefore crucial to develop a robust and high efficiency platform for its manufacturing.
Therapeutic applications of AAV-based gene therapy vectors require the process and product related impurities to be removed, as they represent serious safety threats as well as burden the economics of manufacturing.
Attachments
2020
Presenter: Aleš Štrancar
Date: October 27, 2020
Gene Therapy for Rare Disorders Europe 2020 (digital event)
Bullet points:
- Buffer optimisation and proper column ligand selection (CIM QA, CIM PrimaS or new CIM EF) allows for >90% full capsid production
- Introduction of Specimen allows for production columns checking before use
- Using ultracentrifuge with set of HPLC detectors allows for prompt orthogonal verification of the full capsid purity
Attachments
Presenter: Aleš Štrancar
Date: August 27, 2020
2nd Bacteriophage Therapy Summit 2020 (digital event)
Many of the most compelling applications of bacteriophages involve human therapy, some pertinent to gene therapy, others to antibiotic replacement. These applications require removal of host cell contaminants to acceptable levels, including proteins, DNA and, most of all, endotoxins. This presentation will highlight some of the challenges with effective endotoxin removal, and introduce a new chromatography product that achieves good endotoxin removal while maintaining high recovery of bacteriophage. Case study data will be shared documenting the performance of a platform purification method that enable complete bacteriophage purification within a single shift. Fast analytical methods for qualification of raw materials and tracking phages through the steps of a purification process will also be presented.
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Presenter: Pete Gagnon
Date: 23rd of January 2020
Place: Miami, FL (Phacilitate World Stem Cell Summit)
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2019
Presenter: Ales Strancar
Date: 20th of November 2019
Place: Boston, MA (Gene Therapy Analytical Development Summit)
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Presenter: Pete Gagnon
Date: September 18, 2019
Place: Boston, MA (Exosome Based Therapeutic Development Summit 2019)
Attachments
Presenter: Ales Strancar
Date: 19th of June 2019
Place: Biomanufacturing Training & Education Center (BTEC) in North Carolina