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 yields and formulation strategies that increase 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. The composition of the cell culture media is critical to the regulatory success of VERO-derived viral vaccine products so 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.

InVitria’s Products:

• Reduce or eliminate the introduction of animal-derived, viral RNA and DNA, prion proteins, undefined antigenic molecules, and animal-derived cytokines and hormones.
• Provide more consistent and 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 enhanced 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
• Dengue
• Zika

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 enhance viral titer and viability in biomanufacturing processes.

At a Glance: InVitria Products for Vaccine Applications

*All protein components included in InVitria’s media products are fully human in sequence, 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.