Seminars & Webinars
2021
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.
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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.
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Presenter: Rok Sekirnik
Event: mRNA Therapeutics Summit
Date: July 14, 2021
Abstract:
The recently demonstrated efficacy of mRNA-based Covid-19 vaccines has shown the promise of this therapeutic format, but also highlighted the need for higher efficiency of mRNA production to meet enormous needs for global vaccine supply. Typical mRNA production process involves three key steps: 1) plasmid DNA (pDNA) production in supercoiled (sc) isoform, linearization and purification, 2) in-vitro transcription (IVT) reaction and 3) mRNA purification. Here we present a chromatographic toolbox for integrated mRNA production from pDNA to mRNA purification, including in-process analytics.
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Presenter: Aleš Štrancar
Event: TIDES mRNA Digital Week
Date: June 28, 2021
Abstract:
A new purification approach starting from E.Coli all through to mRNA production is presented here. This new approach integrates a pDNA linearisation step before polishing (removal of linear and open circular isoforms) of plasmid DNA. The polishing step, placed after enzymatic linearisation, purifies linear pDNA from enzyme and other unwanted process impurities. The linearised plasmid DNA is then used in IVT for production of mRNA. Fast in-process analytics allows for transcription number well above 100 in reproducible manner.
This approach further introduces mRNA purification tools for improved contaminant removal. The altered sequence of purification and linearisation reduces the overall number of purification steps required, improves recoveries, while the complete process results in extra low protein impurity and very efficient dsRNA removal.
The participants would get insight into the mRNA production steps, their optimisation and tools to allow for robust process. The analytical tools to allow for safe product will be highlighted, too.
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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.
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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.
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Event: BioProcess International COVID-19 Therapeutic Development & Production
Date: April 27, 2021
Developments in gene therapy and the threat of pandemics requires novel technologies to allow for efficient manufacturing of exceptionally large biomolecules and nanoparticles within a short time. Novel vaccine platforms such as mRNA enable the industry to meet its highest goals: decreasing footprint while increasing efficiency and throughput. However, to respond with agility and prepare for future outbreaks, the mRNA platform must be further optimized.
In vitro transcription (IVT), the enzymatic process used for mRNA vaccine production, is different from biological fermentation processes as it requires linearized plasmid DNA. The linear isoform is produced with restriction enzymes from open circular and supercoiled pDNA. Employing a traditional pDNA manufacturing process, which removes multimers as well as linear and open-circular isoforms, reduces production yield.
However, when pDNA and mRNA are treated as a single production process, the purification steps are optimized, yields improved, and overall production costs reduced. This presentation will describe how Convective Interaction Media monoliths can be used to efficiently purify a board specter of mRNA and cover all production scenarios.
This presentation illustrates fast in-process control methods using the PATfix system, which can ensure the rapid production of the safest possible Covid-19 vaccines while reducing manufacturing costs.
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Event: Nucleic Acids- cGMP Production of mRNA & pDNA (virtual edition)
Date: February 1, 2021
Our new Head of Process Development for mRNA and pDNA purification, Rok Sekirnik, presented our Chromatographic tools for high-yielding mRNA production process as workshop.
Click here to listen to the workshop.
Event: Nucleic Acids- cGMP Production of mRNA & pDNA (virtual edition)
Date: February 3, 2021
Our CEO, Ales Strancar presented our Integrated Production Process of mRNA from E. coli to Highly Purified mRNA
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2020
Presenter: Aleš Štrancar
Date: od demand, October 19-22, 2020
Cell & Gene Therapy Bioprocessing & Commercialization (digital event)
Established processes for pDNA manufacturing include purification steps designed to enrich the supercoiled (sc) isoform. Homogeneous supercoiled isoform improves cell transfection efficiency in fermentation processes and is favoured in cell culture production systems. In vitro transcription (IVT), the enzymatic process used for production of mRNA vaccines differentiates itself from biological fermentation processes by the need for linearised plasmid DNA. The linear isoform is produced with restriction enzymes from open circular and supercoiled plasmid DNA. Employing a traditional pDNA manufacturing process, which removes linear and open-circular isoforms, will therefore reduce the production yield. When plasmid DNA and mRNA are treated as a single production process, the purification steps can be optimised, yields improved, and the overall production cost reduced.
A new purification approach starting from E.Coli all through to mRNA production is presented here. This new approach integrates a pDNA linearisation step before polishing of plasmid DNA. The polishing step, placed after enzymatic linearisation, purifies linear pDNA from enzyme and other unwanted process impurities. The linearised plasmid DNA is then used in IVT for production of mRNA. This approach further introduces mRNA purification tools for improved contaminant removal. The altered sequence of purification and linearisation reduces the overall number of purification steps required, improves recoveries, while the complete process results in extra low protein impurity and very efficient dsRNA removal.
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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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.
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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
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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: 19th of June 2019
Place: Biomanufacturing Training & Education Center (BTEC) in North Carolina