Viral Vector Vaccines

Viral vector-based vaccines constitute a promising part of the biopharmaceutical pipeline, addressing many unmet indications. More than 40 vectors are used in the field of viral vectors for gene therapy and vaccines, with adenoviruses and modified vaccinia ankara viruses used most frequently for vaccine applications, adeno-associated viruses used more commonly for gene therapy, and lentiviruses typically used for gene-modified cell therapy. In order to leverage the full potential of viral vector-based vaccine development, many are looking to innovative technologies to support more productive, intensified, and flexible processes.

Viral Vector Vaccine Platform

Learn why viral vectors are one of the most commonly used platforms in vaccine manufacturing.

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Viral Vector

We invite you to discover the Sartorius toolbox of technologies, dedicated to the production and purification of viral vectors. As you explore our generic process overviews for enveloped vectors, non-enveloped vectors and commonly used vectors, such as adenovirus, AAV, lentivirus and MVA, you can click on each step to reveal the challenges that manufacturers face when working with viral vector-based vaccines– and discover how Sartorius offers unique solutions to meet those needs. You will also find relevant literature on available technologies for the process steps.  


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Generic Viral Vector Vaccine

Cell Line / Strain Selection 

Seed Expansion

Virus Propagation

Clarification

Bioburden Reduction 

Concentration / Diafiltration

Virus Capture Chromatography

Polishing Chromatography

Concentration / Diafiltration

Sterile Filtration

Other Technologies

Viral vector quantification, meaning the measurement of viral vector particle concentration in a defined volume, is invaluable information that’s needed as close to in real-time as possible when developing a viral vector. Existing techniques all have limitations, so employing complementary novel technologies are necessary to ensure rapid and precise quantification.

Need

Solution

Virus infectivity tests can take days or weeks to get results – rapid detection analytics are needed to address that critical issue

ELISA and PCR methods are faster than infectivity tests, but there is a higher incidence of error variability since they measure virus building blocks and derive total titers from these numbers, leading to a need for alternative, reliable analytics

Situations often demand ready-to-use analytics, but ELISA and PCR need development and validation time to ensure method robustness

A lot of virus samples are generated during process development and manufacturing of viral vectors, highlighting the need for an easier workflow allowing rapid quantification of virus samples

The Virus Counter® Platform, a unique and rapid virus quantification method, is the only system able to directly quantify assembled viruses (protein and nucleic acids) for real-time insight

  • Real-time quantification for process monitoring and production optimization can deliver a single sample measurement in three minutes
  • Total viral particle quantification
  • High-specificity and universal ready-to-use quantification reagents
  • The Combo Dye® reagent enables measurement of all viral vectors
  • The Virotag® (antibody-based reagent) enables measurement of specific viral vectors
  • Software-assisted system operation and data analysis limits the risk of variability

Application data:

Advanced chemometric methods such as Design of Experiments (DOE) and Multivariate Data Analysis (MVDA) give broad visibility into data, ultimately leading to greater process reliability and robustness in addition to cost savings

Need

Solution

Quality by Design (QbD) relies on DoE to understand critical process parameters, which is dependent on implementing many experiments – a tool that can help design and plan experiments alleviates the burden

Process Analytical Technologies generate a lot of data that is difficult to analyze, resulting in significant demand for a tool to evaluate  historical data in order to identify correlations, do troubleshooting and gain process understanding

Most viral vectors developers and manufacturers are not statisticians and rely on user-friendly interfaces and software

The Umetrics® suite includes three user-friendly and intuitive software solutions designed for process developers and manufacturers to support data analytics through unique data visualization, extensive wizard functionality and customizable plots to maximize usability and versatility

  • MODDE® is an advanced, high-quality DOE solution designed for ease of use. The benefit of DOE is to gain knowledge and estimate the best operating conditions of a process or product, and with MODDE® ® the graphical interface and analytics support make it easy to interpret results with complete confidence
  • SIMCA® Multivariate Data Analysis (MVDA) software is used for scale and batch-to-batch comparison investigations. SIMCA® transforms data into visual information for easy interpretation, enabling decisions and actions to be taken rapidly and with confidence. SIMCA® helps to analyze process variations, identify critical parameters and predict final product quality. An overview of the process status can be obtained in a few clicks
  • SIMCA® online is a highly efficient software for real-time multivariate statistical process monitoring & control. SIMCA®-online provides a complete set of interactive and visual monitoring tools to production teams, to ensure that batch and continuous operations run smoothly

These software solutions are fully integrated in most Sartorius systems and are available as stand-alone program

Application Data:

The increasing development of single-use technologies with integrated single-use sensors has not only enabled real-time data gathering and analysis, it has resulted in process efficiencies, reduced risk of contamination, improved operator safety and overall titer improvements 

Need

Solution

Viral vector manufacturers want to better understand and control their processes, which are very complex and highly regulated, but to do so requires real-time measurement of critical process parameters to allow process monitoring, set-point control (feed control and bleed control), event time point predictions (harvest and infection) and timely identification of process deviations

A range of PAT sensors would be required to effectively apply QbD principles and ensure consistency in product quality and quantity, quickly identifying and correcting process deviations to reduce the risk of lost batches

The ability to integrate PAT into single-use systems would mitigate risk of spillages and contamination during sampling

BioPAT® toolbox, an expending range of fully qualified single-use sensors, are integrated across the Sartorius portfolio making Sartorius the market leader for PAT

  • Available in process development and manufacturing technologies for full process understanding, monitoring and control
  • Data analysis is straightforward thanks to the full integration in the Sartorius products & technologies
    • BioPAT® Viamass for inline monitoring of viable cell density and automated cell bleed control
    • BioPAT® Trace for online monitoring of glucose and lactate and automated feed control
    • BioPAT® Xgas for inline monitoring of CO2 and 02
    • BioPAT® Spectro platform for Raman spectroscopy integration in Ambr® and STR bioreactor systems for non-invasive, inline measurement of multiple analytes
    • BioPAT® Single-Use Sensors for accurate monitoring of critical process parameters, including pH, conductivity, dissolved oxygen, flow rate and pressure. These sensors are integrated throughout Sartorius portfolio of Bioprocessing Systems, according to each unit operation’s specific needs

Application data:

Adenovirus-Based Vaccines

Adenoviruses are non-enveloped DNA viruses commonly used as viral vectors, offering a wide range of advantages:  

  •     Can be easily genetically manipulated
  •     Are non-replicating
  •     Accept large transgene DNA inserts
  •     Generate a robust transgene-specific T and B response

They were first evaluated as a vector for gene therapy, but are now mostly used for vaccine applications, as well as oncolytic viruses. More than 50% of viral vector-based vaccines are using adenoviruses today. The first adenovirus-based vaccine that made it to the market is against Ebola.  

We invite you to discover the Sartorius toolbox of technologies dedicated to the production and purification of viral vectors. As you explore our generic process adenovirus process overview, you can click on each step to reveal the challenges that manufacturers face when working with adenoviruses – and discover how Sartorius offers unique solutions to meet those needs. You will also find relevant literature on available technologies for the process steps.

Contact a Vaccine Specialist

Adenovirus Vaccine

Cell Line / Strain Selection 

Seed Expansion

Virus Propagation

Clarification

Bioburden Reduction 

Concentration / Diafiltration

Virus Capture Chromatography

Polishing Chromatography

Concentration / Diafiltration

Sterile Filtration

Other Technologies

Advanced chemometric methods such as Design of Experiments (DOE) and Multivariate Data Analysis (MVDA) give broad visibility into data, ultimately leading to greater process reliability and robustness in addition to cost savings.

Need

Solution

Quality by Design (QbD) relies on DoE to understand critical process parameters, which is dependent on implementing many experiments – a tool that can help design and plan experiments alleviating the burden

PAT generate a lot of data that is difficult to analyze, resulting in significant demand for a tool to evaluate historical data in order to identify correlations, do troubleshooting and gain process understanding

Most of vaccine developers and manufacturers are not statisticians and rely on user-friendly interfaces and software

The Umetrics® suite brings together three user-friendly and intuitive software programs designed for process developers and manufacturers to support data analytics through unique data visualization, extensive wizard functionality and customizable plots to maximize usability and versatility

  • MODDE® is an advanced, high-quality DOE solution designed for ease of use. The benefit of DOE is to gain knowledge and estimate the best operating conditions of a process or product, and with MODDE® the graphical interface and analytics support make it easy to interpret results with complete confidence
  • SIMCA® Multivariate Data Analysis (MVDA) software is used for scale and batch-to-batch comparison investigations. SIMCA® transforms data into visual information for easy interpretation, enabling decisions and actions to be taken rapidly and with confidence. SIMCA® helps to analyze process variations, identify critical parameters and predict final product quality. An overview of the process status can be obtained in a few clicks
  • SIMCA® online is a highly efficient software for real-time multivariate statistical process monitoring & control. SIMCA® online provides a complete set of interactive and visual monitoring tools to production teams, to ensure that batch and continuous operations run smoothly

These software options are fully integrated in most Sartorius systems and are available as stand-alone program


The increasing development of single-use technologies with integrated single-use sensors, has not only enabled real-time data gathering and analysis, it has resulted in process efficiencies, reduced risk of contamination, improved operator safety and overall titer improvements.

Need

Solution

Viral vector-based vaccine manufacturers want to better understand and control their processes, which are very complex and highly regulated, but to do so requires real-time measurement of critical process parameters to allow process monitoring, set-point control (feed control and bleed control), event time point predictions (harvest and infection) and timely identification of process deviations

A range of PAT sensors would be required to effectively apply QbD principles and ensure consistency in product quality and quantity, quickly identifying and correcting process deviations to reduce the risk of lost batches

The ability to integrate PAT into single-use systems would mitigate risk of spillages and contamination during sampling

BioPAT® toolbox, an expending range of fully qualified single-use sensors, are integrated across the Sartorius portfolio making Sartorius the market leader for PAT

  • Available in process development and manufacturing technologies for full process understanding, monitoring and control
  • Data analysis is straightforward thanks to the full integration in the Sartorius products & technologies  
    • BioPAT® Viamass for inline monitoring of viable cell density and automated cell bleed control
    • BioPAT® Trace for online monitoring of glucose and lactate and automated feed control
    • BioPAT® Xgas for inline monitoring of CO2 and 02
    • BioPAT® Spectro platform for Raman spectroscopy integration in Ambr® and STR bioreactor systems for non-invasive, inline measurement of multiple analytes


Contact a Vaccine Specialist