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Seminars & Webinars

2021

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 HPLC to allow for analysis of the full and empty capsids ratio during the virus expression.

Fast and reliable in HPLC methods to allow for process optimisation USP and DSP, 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 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 HPLC 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 in HPLC 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: 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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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.

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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

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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