Driven by epidemic events and by governmental vaccination programs, there is a rising demand for development of new vaccines and the industry is growing at a double-digit rate. Companies need to set up flexible processes, optimized to balance costs and time-to-market. New technologies such as single-use equipment and automation open up new possibilities in terms of quality control and validation, especially in GMP environments.
The vaccine industry is facing the challenge of developing new products to serve so far unmet needs and fulfilling the demands on dose numbers, both 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.
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.
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.
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.
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.
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: High-density Vero cell perfusion culture
> Download application: Small scale perfusion using an ATF cell retention device
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.
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.
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.
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.
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, Reasearch 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.
