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Seminars & Webinars

2021

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

Click here to listen to the presentation.

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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  

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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.

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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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To listen to audio podcast online click here.

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Presenter: Ales Strancar

Date: 19th of June 2019

Place: Biomanufacturing Training & Education Center (BTEC) in North Carolina

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