Attenuated and Inactivated Virus Based Vaccines
Viral vaccines include inactivated viral vaccines and live-attenuated viral vaccines. Both rely on a traditional approach i.e.; the disease-causing virus is identified, produced in a bioreactor, and purified. This type of strategy has been used for many diseases with success, and most of the current vaccines against viral diseases use this strategy. This approach, however, does have its challenges:
- Ensuring the capacity of a virus to be produced in a bioreactor
- Identifying the right host cell
- Designing a process tailored to each disease
- Complying with the requirements of production at a high biosafety level to protect operators and the environment
We, at Sartorius, understand the needs of vaccine developers and producers working with viral vaccines and have developed a dedicated toolbox of solutions.
Inactivated Viral Vaccine
Inactivated viral vaccines represent a significant part of the vaccine market, influenza and polio chief among them. In addition to new vaccine developments, process transfers, capacity expansions and continuous improvement can lead to positive disruption in this space with technologies that make safer and more productive processes possible, helping to decrease overall costs.
We invite you to discover the Sartorius toolbox of technologies, dedicated to the production and purification of inactivated viral vaccines. As you explore our generic process overviews for enveloped viruses, such as SARS-CoV-2, non-enveloped viruses and specific viruses such as influenza and polio, you can click on each step to reveal the challenges that manufacturers face when working with inactivated viral 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 Inactivated Virus
Cell Line / Strain Selection
Seed Expansion
Virus Propagation
Clarification
Bioburden Reduction
Concentration / Diafiltration
Virus Capture Chromatography
Polishing Chromatography
Inactivation / Split
Concentration / Diafiltration
Sterile Filtration
Other Technologies
Viral quantification, meaning the measurement of viral particle concentration in a defined volume, is invaluable information that’s needed as close to in real-time as possible when developing a vaccine. 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 based vaccines, 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
|
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 of vaccine 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 programs |
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 |
---|---|
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
|
Application Data:
Live-Attenuated Viral Vaccine
As a result of advances in the fields of molecular biology and genetic engineering, a new generation of live-attenuated viral vaccines is emerging. Vaccines for viruses such as influenza, as well as newer applications such as dengue or respiratory syncytial virus (RSV) are part of this promising pipeline. As is often the case with areas experiencing rapid advancement, innovative technologies are required to keep step with new processes to continuously improve upon safety and productivity.
We invite you to discover the Sartorius toolbox of technologies, dedicated to the production and purification of live-attenuated viral vaccines. As you explore our generic process overviews for enveloped viruses, such as SARS-CoV-2, non-enveloped viruses and specific viruses such as dengue and RSV, you can click on each step to reveal the challenges that manufacturers face when working with live-attenuated viral 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 Attenuated Virus
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 quantification, meaning the measurement of viral particle concentration in a defined volume, is invaluable information that’s needed as close to in real-time as possible when developing a vaccine. 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 based vaccines, 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
|
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 of vaccine 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 programs |
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 |
---|---|
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
|
Application Data: