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Seminars & Webinars

2022

Speaker: Mojca Tajnik Sbaizero, Project Manager 

rAAV downstream process using monoliths contains a series of steps that are mutually dependent. Therefore each step should be optimized for sufficient outcome. Standard 96-well design offers a great advantage for screening many samples and conditions. It supports small sample intake and process automatization. We will present example of multi-parallel screening of different mobile phases for rAAVcapture step using CIM SO3 0.05 mL Monolithic 96-well Plates. Optimization of capture step leads to increased process productivity and product purity, as well as improves later polishing step. High vector recovery and greater reduction of impurities were confirmed on preparative scale chromatography resulting in successful implementation of screening tools for process development optimization.

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Event: LCGC Live Webcast

Date: March 17, 2022

Presenters:  

Rok Zigon, Project Manager; Process Development Dept.

Blaz Goricar, Project Manager; Process Analytical Technology Dept.

Key learning points:

  • Rapid downstream process of AAV using monoliths, with emphasis on PATfix HPLC analytical tools
  • Orthogonal analytics are paramount for AAV characterization
  • Integration using PATfix enables fast evaluation of empty-full ratio

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Event: Cell and Gene Therapy Insights webinar

Date: February 17, 2022

Presenter: Ales Strancar, Managing Director

Key learning points:

  • One of the key challenges in manufacturing viral vectors is to increase the ratio between empty and full capsids.
  • When the expression in the cell line results in less than 10% full capsid it is quite impossible to reach better than 90% full in the final product. It is therefore mandatory to optimise the USP to result in better empty/full ratio.  
  • This can be efficiently realised by 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 removed by polishing step using different anion exchange columns.

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2021

Published: Cell & Gene Therapy Insights 2021; 7(12), 1661

Date: December 20, 2021

Presenter: Maja Leskovec, Head of Process Development Viruses (viral vectors and vaccines)

Watch the video or read the poster to learn:

  • Importance of sample pretreatment before first chromatographic step
  • Rapid downstream process of AAV with emphasis on chromatographic step of CIMmultus SO3 capture
  • Three different ligands full enrichment of AAV
  • Why orthogonal analytics is the key in downstream development and what are the options

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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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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 

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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: 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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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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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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