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.
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.
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
|
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
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
|
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
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
|