- Vaccine Production
Serum-Free Vaccine Cell Culture Components
Regulatory-Friendly Production of Viral Vaccine Components in VERO Cells
The future of viral-vaccine production lies in scalability, rapid development and production cycles, dependable, consistent yields, and formulation strategies resulting in increased shelf-life and stability of the final product. The mammalian continuous cell line VERO has been developed to satisfy vaccine production requirements and is fast becoming preferred over egg-based methods for industrial-scale production of viral products. Critical to the regulatory success of VERO-derived viral vaccine products are the composition of the cell culture media in which they are grown and the purity and safety of final formulation excipients; media supplements based on bovine serum-derived products or plant hydrolysates are poorly controlled and include undefined additives that may complicate manufacturing and regulatory compliance.
InVitria’s fully recombinant human serum protein supplements, chemically defined media, and excipients are optimized for regulatory-friendly, serum-free growth and maintenance of VERO cells, and commercial-scale production and formulation of viral particles for vaccine applications. All products are manufactured biosynthetically in the US, using recombinant DNA technology in an animal-free host, in an ISO 9001:2015 certified facility. These products are suitable for RUO and cGMP uses and enable the reduction or elimination of serum, serum-purified proteins, and serum-derived contaminants from cell culture media at any scale.
- Reduce or eliminate the introduction of animal-derived, viral RNA and DNA, prion proteins, undefined antigenic molecules, and animal-derived cytokines and hormones.
- Provide better, more consistent, more scalable cell expansion and performance in culture, and higher viral titers, product validation, and clinical safety of downstream clinical products
- Stabilize viral particles for storage and injection without concern for introducing undefined substances into the final formulation
- Eliminate concerns about the fluctuating global agricultural supply chain and limitations on availability of bovine serum
InVitria products for vaccine-related applications include:
OptiVERO Complete Media
OptiVERO complete media is a pre-formulated, serum-free, chemically defined medium optimized for both traditional tissue culture flasks and scalable bioreactor formats. OptiVERO Complete promotes superior expansion kinetics of VERO cells as well as superior viral titers for clinical and commercial manufacturing. OptiVERO Complete takes the guesswork out of transitioning quickly and painlessly to regulatory-friendly, serum-reduced or serum-free cell culture for your RUO or cGMP needs. Read more…
OptiVERO Complete has been tested for its ability to support optimal VERO-based production of clinically relevant viruses, including:
- Influenza A
- Influenza B
Animal-Free, Serum-Free Cell Culture Components and Supplements:
- Cellastim S recombinant human albumin to replace BSA or purified human albumin in VERO cell culture.
- Optiferrin recombinant human transferrin for managing iron in serum-free or serum-reduced culture applications.
- Insulin-transferrin supplements to provide supplemental rh-insulin rh-transferrin, and selenium, with or without ethanolamine and rh-albumin for serum-free or serum-reduced culture applications.
Exbumin Recombinant Human Serum Albumin – the First rHSA Approved for Excipient Applications by FDA and EMA
- InVitria excipient-grade, regulatory-friendly recombinant human serum albumin is manufactured in an animal-free host and has been approved for use in the final formulation of injectable biologics by both the FDA and the EMA, with data from more than 250,000 safe human injections. For example, Exbumin is incorporated into the first FDA and EMA approved Ebola vaccine – ERVEBO. Exbumin is also used to improve viral titer and viability in cell cultures during the biomanufacturing process.
OptiPEAK Media Optimization Services
InVitria offers the experience and know-how to help you supplement your media of choice with its full line of animal-free, serum-free, recombinant individual cell-culture components. Our Product Applications team is ready to help you build a serum-reduced or chemically defined medium optimized to your application.
InVitria Custom Media Formulation Services
Have specific needs or a proprietary cell type or viral particle? To learn more about transitioning your viral vaccine production system to complete, chemically defined, serum-free media, contact us or follow the link to InVitria’s Custom Media Formulation services page.
At a Glance: InVitria Products for Vaccine Applications
|Name||Function||Recombinant||Human sequence||Animal Free||Blood Free||IgG Free||Available grades|
|Defined, Complete Cell-Culture Media Solutions|
|Media Optimization and Custom Media Formulation Services||InVitria’s Product Application Specialists have the knowledge and experience to help you build a custom, scalable, serum-free or reduced-serum solution to meet the needs of your specific combination of cell type, viral particle, and biomanufacturing process.||✅||✅||✅||✅||✅||RUO
|OptiVERO||Serum-free or serum-reduced culture of VERO cells, for propagation and production of adeno-associated virus and lentivirus vectors for cell therapy applications in tissue culture and bioreactors||✅||✅||✅||✅||✅||RUO
|Excipients and Individual Cell Culture Components|
|Exbumin||Excipient-grade, animal-free, serum-free recombinant human albumin to improve stability of viral particles during commercial production. Exbumin is approved for use as an excipient in injectable vaccines and therapeutics.||✅||✅||✅||✅||✅||cGMP|
|Cellastim S||Animal-free, serum-free recombinant human albumin to replace BSA and FBS in serum-free or serum-reduced culture of viral host cells.||✅||✅||✅||✅||✅||cGMP|
|Optiferrin||Animal-free, serum-free recombinant human transferrin for iron nutrition and management in serum-free or serum-reduced culture of viral host cells.||✅||✅||✅||✅||✅||cGMP|
|ITS, ITSE, ITSE+A Insulin-Transferrin Supplements||Provides supplemental rh-insulin rh-transferrin, and selenium, with or without ethanolamine and rh-albumin for serum-free or serum-reduced culture of viral host cells.||✅||✅||✅||✅||✅||cGMP|
*All protein components included in InVitria’s media products are fully human in sequence, fully recombinant, and expressed in a non-animal host. All processing and packaging steps are fully free of animal components and are produced in the US, using cGMP standards in an ISO 9001:2015 certified facility.