the manufacture of killed viruses
Inactivated viruses or killed vaccines are manufactured through the growth of the target virus in cell cultures. Purification is accomplished by the use of advanced chromatographic processes to remove the process-related impurities. Different purification technologies may be used.
The purified virus is then inactivated to lose it´s inherent disease producing capacity using either a physical or chemical Inactivation. A chemical inactivation usually uses formaldehyde, and Heat will often be used as a form of physical inactivation.
Our EU-GMP certifications has covered the manufacture of several inactivated vaccines such as Polio, Hepatitis A, Influenza.
Single-use systems are used broadly to minimize the risk of cross-contaminations.
Process Development capabilities
Our versatile team has an extensive skillset in the development, optimization and validation of bioprocesses related to the manufacture of inactivated vaccines.
GMP compliant capabilities
Naobios is manufacturing vaccines drug substances and small scale drug product based on inactivated viruses and all intermediates (such as cell and virus banks) under the scope of our GMP license.
Our multipurpose site consists of BSL2 and BSL3 laboratories which accommodates aseptic or non-aseptic processes while using state of the art technologies to best meet our sponsors’ technical requirements.
Our downstream equipments ensure scalability and includes modern chromatography tools and filtration steps such as dead end Filtration, TFF (Tangential Flow Filtration) and sterile filtration (whenever possible).
Quality control testing
Characterization and release of produced material is perfomed through the use of fully validated assays available at Naobios, with our sister company’s help, Clean Cells or with tailored analytical development and validation. Testing of the inactivated vaccines follows global regulatory standards and is adjusted according to the clinical stage of the product.
The following pages are there to guide you through our QC portfolio: