Seminars & Webinars
2021
Published: Cell & Gene Therapy Insights 2021; 7(10), 1437
Date: November 15, 2021
Presenter: Nejc Pavlin, Project Manager in Process Analytics Development department
Watch the video or read the poster to learn:
- The importance of pDNA as an enabling product in the production of mRNA, AAV, and other therapeutic vectors
- How the PATfix™ pDNA platform using CIMac™ pDNA column offers fast and efficient solution for problems related to pDNA upstream and downstream processes
- How the PATfix™ pDNA platform can be used to optimally adjust pDNA production and purification procedures of pDNA according to your needs, increasing pDNA yield and purity and reducing the cost of its production
Attachments
Presenter: Ivana Petrović Koshmak, PhD
Event: Late Stage Bioprocessing & Viral Vectors 2 11 November 2021
Date: November 3, 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.
One of the key challenges in manufacturing viral vectors is to increase the ratio between empty and full capsids. The most efficient way is to design the USP to result in less than 10% of empty capsids. This can be realised by process optimisation using at-line PATfix analytics to allow for analysis of the full and empty capsids ratio during the virus expression.
Fast and reliable at-line analytical methods to allow for process optimisation USP and DSP, and assessing the purity of the final product using PATfix system will be presented.
Attachments
Published: Cell & Gene Therapy Insights 2021; 7(8), 1125
Date: October 4, 2021
Presenter: Hana Jug, Project Manager in process development for viral vectors and vaccines
Watch the video or read the poster to learn:
- Why downstream processing remains one of the main bottlenecks in adenoviral vector manufacturing
- How an adenoviral vector purification platform using CIMmultus™ QA as the key purification step, secures a fast and robust process with better purity
- CIMmultus™ QA offers high capacity and high yields of adenovirus, results in cost reduction and overcomes raw material supply bottlenecks
Attachments
Presenter: Aleš Štrancar
Event: BPI and Cell & Gene Therapy Bioprocessing & Commercialization 2021
Date: September 28, 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.
One of the key challenges in manufacturing viral vectors is to increase the ratio between empty and full capsids. The most efficient way is to design the USP to result in less than 10% of empty capsids. This can be realised by process optimisation using at-line biochromatography analytics to allow for analysis of the full and empty capsids ratio directly in the harvest.
The residual empty capsids can be further removed by polishing purification step using different anion exchange columns.
Fast and reliable at-line analytical methods to allow for process optimisation and assessing the purity of the final product using PATfix system will be presented.
Attachments
Presenter: Aleš Štrancar
Event: BPI and Cell & Gene Therapy Bioprocessing & Commercialization 2021
Date: September 30, 2021
Abstract:
Global demand for pDNA production is at an all time high, due to increased need from Gene Therapy ramp-up. pDNA, as an enabling product, is critical in production of mRNA, AAV and other therapeutic vectors. Increasing yield and purity in the production of pDNA is a vital step in meeting such demand. Supporting reliable in-process control during pDNA purification, PATfix pDNA analytical platform is enabling rapid process development and optimization while providing a reliable analytical platform for production runs.
Attachments
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
Messenger RNA is poised to become a major contributor in the fields of gene therapy and vaccines. Making this a practical reality requires purification technology that accommodates its unique features and challenges. Some of those challenges are inherent to mRNA. Others are byproducts of RNA synthesis.
This presentation addresses both and introduces a coordinated purification toolbox to advance the evolution of mRNA therapy.
Attachments
Presenter: Ingo Nagler
Date: June 3, 2020
Biomanufacturing and Cell & Gene Strategy Meetings (Proventa International's online meetings)
Click here to listen to BIA's Keynote Presentation
Attachments
Presenter: Ingo Nagler
Date: May 14, 2020
Asia’s SARS-CoV-2 Vaccine Development Challenges (Corona360 In-Conversation webcast series)
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2019
Presenter: Ales Strancar
Date: 20th of November 2019
Place: Boston, MA (Gene Therapy Analytical Development Summit)
Attachments
Presenter: Ales Strancar
Date: 19th of June 2019
Place: Biomanufacturing Training & Education Center (BTEC) in North Carolina