Seminars & Webinars
2022
Event: Cell and Gene Therapy Insights webinar
Date: June 7, 2022
Presenter: Nejc Pavlin
Pre-developed and validated PATfix analytical methods using different column chemistries enable:
- Effective control over linear plasmid upstream and downstream,
- IVT reaction optimization for mRNA synthesis,
- Control of yield, purity and downstream process of mRNA,
- mRNA formulation and stability analysis,
- Scale-up optimization.
In this webinar, will discuss a robust analytical tool PATfix™ platform, and its specific methods for pDNA and mRNA analytics that enable efficient monitoring of key upstream and downstream process steps will be showcased.
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: 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: 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
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
Attachments
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
2019
Presenter: Ales Strancar
Date: 19th of June 2019
Place: Biomanufacturing Training & Education Center (BTEC) in North Carolina