Process Train for Both Inactivated & Live Attenuated Virus
Virus-based vaccines consist of either attenuated or inactivated virus. These vaccines can activate all phases of the immune system and offer rapid and durable long-term immunity by eliciting neutralizing antibodies against the target pathogen.
The process to manufacture attenuated virus-based vaccines is complex, consists of multiple steps and must maintain the infective potential of the attenuated virus. While there is a general workflow for production, a templated approach for manufacturing does not exist. Instead, each process must be tailored based on the shape, size, nature, physico-chemical behavior, stability, and host specificity of the virus.
Biopharmaceutical Applications Guide
Brochure: Vaccine Bioprocessing Handbook
Mini-Handbook: Cell-Based Vaccine Bioprocessing
Brochure: Enabling Solutions for Vaccines and Viral Therapies
White Paper: Filtration Strategies for Optimal Development and Purification of a Foot and Mouth Disease Virus
White Paper: Downstream Process Intensification for Virus Purification Using Membrane Chromatography
Application Note: Effect of Benzonase® Endonuclease Addition to Purification of Sabin Polio Virus Type 3
Technical article: Choosing the Optimal Cell Culture Media for Vaccine Production
Technical Article: Choosing the Optimal Vaccine Adjuvant
Article: Nucleic Acid Impurity Reduction in Viral Vaccine Manufacturing
Article: Filter-Based Clarification of Viral Vaccines and Vectors
Upstream culture processes developed for manufacturing of virus-based vaccines must be optimized to meet productivity requirements. This optimization includes the clarification step which is essential for removal of cells and cell debris and to ensure a robust virus harvest. The upstream process is only successful, however, if it can be reliably scaled in order to meet anticipated market demand.
Nucleic acids from lysed cells are a common contaminant in virus-based vaccine processes. Regulations require that the level of carry-over host cell nucleic acid must be below 10 ng/dose of attenuated virus-based vaccine. Benzonase® endonuclease treatment followed by tangential flow filtration is a robust and powerful combination to degrade and then remove residual nucleic acid components.
Benzonase® endonuclease treatment is sufficient to achieve the desired level of purity for most virus-based vaccines during concentration and diafiltration. Chromatography is required, however, to achieve purity goals for next generation virus-based vaccines such as Japanese encephalitis virus (JEV) and dengue virus (DENV). Because each manufacturing process must be tailored to the characteristics of the virus, a toolbox of options for downstream purification is essential to deliver the desired purity while ensuring an optimal recovery.
Even though virus-based vaccines are manufactured using attenuated viruses, ensuring the safety of patients remains an important concern. The final virus vaccine bulk is comparable to that of water. As such, the vaccine can be sterilized using 0.22 µm sterilizing filtration prior to the final formulation and fill finish steps.
Maximize upstream productivity of virus-based vaccines
Ensure robust scalability
We offer the industry’s highest quality sterile filtered liquid capabilities, supplying ready-to-use cell culture media, buffers, CIP and SIP products from GMP facilities worldwide to optimize your biopharma production.
Achieve yield, efficiency and virus recovery goals while ensuring robust impurity removal
Remove cross product contamination concerns while streamlining fill-finishing requirements and complying with current regulatory requirements
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