Optimizing quality and consistency in large-scale virus vaccine production is key to delivering safe and effective vaccines at an affordable price. With robust and reliable ultracentrifugation technologies playing an important role in high-quality virus purification and concentration, we look at how the enhanced reproducibility and workflow reliability offered by the Thermo Scientific™ Sorvall™ CC40NX Ultracentrifuge Series of fully automated, large-scale, continuous-flow ultracentrifugation systems have helped one large vaccine manufacturer to achieve the highest levels of product quality and consistency.
Protecting product integrity in virus vaccine production
A critical step in virus vaccine manufacturing is the separation of the virus from the culture medium, a process that’s often achieved by ultracentrifugation. Product integrity is paramount in delivering safe and effective medicines, and the ultracentrifugation technologies employed in the continuous-flow workflows used to manufacture virus vaccines must therefore minimize product contamination. This can often occur when there is no contamination control strategy in place. With single batches of vaccines worth in the region of USD $500,000, contamination events can be very costly for manufacturers, resulting in entire batches being wasted. As a consequence, these contamination events can drive up the cost to health payers and reduce the amount of money that can be reinvested into vaccine R&D.
For one leading pharmaceutical manufacturer investing in a state-of-the-art virus vaccine manufacturing facility, efficient, large-scale ultracentrifugation technologies were key to their strategy for increasing productivity while safeguarding product quality. In short, they needed a robust solution that would reduce non-quality costs by minimizing product wastage. Delighted with the high levels of process reliability and product consistency that had already been achieved using the Sorvall™ CC40NX Ultracentrifuge Series elsewhere in the business, it was clear that the fully automated ultracentrifugation systems with contamination control strategy were the right technology for the job. The virus vaccine manufacturer’s industry-leading facility now houses multiple large scale ultracentrifuges that operate continuously for around 50 weeks every year, ensuring uninterrupted, efficient production. The new ultracentrifuges have substantially reduced product wastage by assuring the production of consistently pure, high-quality vaccines. And as well as being operationally robust and eliminating downtime due to contamination events, the new systems have been fully contained within clean room environments. That user says they used competitive equipment for decades and now using the fully automated Sorvall™ CC40NX Ultracentrifuge Series makes a great difference in their production day with smoother operation at less cost.
Automation driving quality in virus vaccine manufacturing
In addition to ensuring the highest levels of operational robustness and reliability, the Sorvall™ CC40NX Ultracentrifuge Series have also automated the company’s vaccine production workflows. This has helped the vaccine manufacturer to standardize manufacturing processes and achieve unparalleled levels of product consistency and quality by eliminating the operator variability associated with manual workflows, further reducing product wastage due to defective products. Thermo Fisher Scientific is able to work with customers to develop tailor-made automation and process control solutions, and in this case, we worked with the vaccine manufacturer to develop a customized integrated process control system to bring together all of their instrumentation, workflows and products in a single, simplified system with an integrated user interface. Moreover, to ensure the manufacturer was fully compliant with regulatory obligations, the system met all CFR21 Part 11, USP Class 6 requirements among others.Alternatively, for pharmaceutical manufacturers looking for an off-the-shelf solution, companies can combine Sorvall™ CC40NX Ultracentrifuge Series instruments with the Thermo Scientific™ Automated Integrated Process Control accessory to support their industrial-scale continuous flow needs. By improving product quality and consistency and reducing wastage, the Sorvall™ CC40NX Ultracentrifuge Series of automated, large-scale, continuous-flow ultracentrifugation systems are helping pharmaceutical manufacturers deliver safe, effective and affordable virus vaccines.
Learn more about the Thermo Scientific™ Sorvall™ CC40NX Ultracentrifuge Series.