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Bioprocessing in Vaccine Development and Manufacturing

Solutions for vaccine process development through production

The development of new vaccines is challenging and requires profound knowledge of processes and high-quality equipment. New bioprocess technologies such as single-use equipment and process automation open up novel possibilities for quality control and validation. This is especially important in GMP regulated environments such as in the development and manufacturing of new vaccines.

The COVID-19 pandemic starting in 2020 underlined the strong need for the efficient development of new processes. The fast and reliable tech transfer of these processes to scale up to clinical production volumes is key for the efficient development of new vaccinations.

Vaccine; vaccines; Vaccination development; vaccine bioprocessing; vaccine manufacturer; Eppendorf; Expert partner

Introduction to vaccines and vaccine development

At the beginning of a new vaccine there is the decision about the vaccine type and the selection of the antigen. In vitro and in vivo studies precede the development of a manufacturing process. Get to know more about vaccines and their development.

> Watch Dialogue: All You Need To Know About Vaccines

> Download Vaccine Workflow: Advanced Solutions for Vaccine Discovery and Development

Vaccine Workflow Infographic
Panel Discussion on Vaccine Development

COVID-19 and rethinking vaccine development

A need for new methods to increase speed and yield, and to produce new vaccines in a cost-effective manner in order to remain competitive is a constant concern for scientists, especially in the field of COVID-19. We see a trend towards collaboration in the biotechnology industry in order to accelerate the research, development and large-scale production of new vaccines.

> Watch Panel Discussion: Rethinking Vaccine Development

> Download Editorial: The Role of Bioreactors in the Development of COVID-19 Vaccines

> Download Interview: Important Tools for Efficient Vaccine Development

> or listen to Podcast: Important Tools for Efficient Vaccine Development

Challenges in vaccine upstream bioprocessing

Vaccine manufacturers are facing the challenge of developing new products to serve unmet needs and fulfill the demands in an economically viable way. Upstream bioprocessing is an important piece of the puzzle. Read expert views and case studies on some of the hot topics in vaccine bioprocess development.

 

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eBook: vaccine bioprocessing
Article about Vaccine Reserach and process development

Vaccine research and process development

Modifying vaccines in response to changes by the respective virus or agent is a constant challenge for vaccine manufacturers. Hence, process development is a key element in the creation of improved, more rapid, and lower-cost methods for production. 

 

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Viral vector production

Webinar: Vero Cell Cultivation for Vaccine Production

Anchorage-dependent cells, such as Vero cells, are widely used as a platform for viral vector production. In this webinar our colleague Amanda Suttle demonstrates how different process parameters can be controlled in a perfusion bioprocess to cultivate anchorage-dependent cells.

 

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Interview with Philip Nold and Ankita Desai about viral vector production

Interview: Challenges for viral vector production

Viral vectors are used in molecular biology research, gene therapy applications, and in vaccine development. High yield, scalability, robustness and commercial viability are some of the demands bioprocess engineers impose on bioprocesses for viral vector production. Cell & Gene Therapy Insights has talked with our colleagues Ankita Desai and Dr. Philipp Nold, bioprocess field application specialists, about the challenges they see in upstream bioprocess development for viral vector production.

 

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Application Note on the development of a scale-down model for rAAV viral vector productions with Généthon

Researchers at Généthon® developed a scale-down model for rAAV viral vector production in a Sf9/BEV system using a DASbox Mini Bioreactor System. They reproduced cell growth and production performance. The DASbox system allowed the comparison of different experimental conditions in parallel runs, which accelerated scale-down model development.

 

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Researchers at Cevec Pharmaceuticals adapted the small scale shake flasks rAAV production process to stirred-tank bioreactors and scaled it up from a working volume of 2 L to 10 L, using BioBLU Single-Use Vessels. It led to comparable cell growth and virus production at both scales and to the original shake flask process.

 

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Application Note about rAAV production in suspension CAP GT cells with Cevec Pharmaceuticals
Application Note on transient lentiviral vector production using a BioFlo 320 with a BioBLU 5p

Lentiviral vectors (LVs), which are especially applicable to gene therapy, are promising vector types for the clinical trials of such treatments. This application note describes the first successful experimental setup to cultivate LVs in HEK 293T cells adherently grown on Fibra-Cel® disks in a BioBLU 5p Single-Use Vessel.

 

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Perfusion culture systems

Continuous cultivation techniques and perfusion have the potential to increase the efficiency of biopharmaceutical manufacturing processes. They can help increasing product titers while decreasing production volumes needed. 

 

> Download application: Easy perfusion for anchorage-dependent cell culture

> Download application: High-density Vero cell perfusion culture

> Download application: Small scale perfusion using an ATF cell retention device

eBook on the cultivation of vero cells in packed.bed bioreactors

Vero cells are anchorage-dependent cells that are widely used as a platform for viral vaccine production. In stirred-tank bioreactors, they are grown ordinarily on microcarriers. Fibra-Cel® disks are an alternative attachment matrix because they provide a three-dimensional environment that protects cells from damaging shear forces. The cultivation of Vero cells in benchtop single-use and glass bioreactors with a packed bed made of Fibra-Cel disks has been tested.

 

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Kamal A. Rashid, PhD, Director of the Biomanufacturing Education and Research Center, and Research Professor, Worcester Polytechnic Institute, reports on the cultivation of CHO cells in the BioBLU® 5p Single-Use Vessel in perfusion mode. The packed-bed basket technology, developed by Eppendorf, provides a shear-free environment for the production of animal cells.

 

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Application Note on CHO cell culture
Application Note on leachable studies on mammalian cell culture

Single-use technology

Single-use bioreactors are routinely used in biopharmaceutical R&D and biologics manufacturing. They have the potential to reduce turn-around times and the risk for contaminations and make validations easier. One potential problem of single-use systems, however, is the release of chemical compounds into the culture medium. Standardized tests help investigating the effects of leachables and extractables (L&Es) on cell growth.

 

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Microbial vaccine development

Recent surveys see an increasing demand of microbial expression systems in the biopharmaceutical industry. Their advantages are obvious: Bacterial hosts are easy to cultivate, grow fast, and media are less expensive than complex cell culture media. A growing range of single-use fermentors has the potential to diminish labor costs, shorten turn-around times, and make validation easier.

 

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Application Note on scalability of parallel e.coli fermentations in BioBLU f single-use bioreactors
Interview with Charlotte Mignon, Research Engineer from BIOASTER

BIOASTER® Technology Research Institute (TRI) is working to develop a microbial technology platform to improve safety and efficacy of vaccines and to develop diagnostic tools. They use a DASbox® Mini Bioreactor System equipped with BioBLU Single-Use Vessels in order to enhance their process development efforts.

Charlotte Mignon, Research Engineer at BIOASTER, discussed her motivation on the job, what her research is about and how she spends her free time in an interesting interview.

 

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