JULY 202319storage, handling, stock management and delivery of vaccines to the remotest locations. Similarly, GAVI, the major funding agency for vaccine supplies to LMIC across the world also helps in distribution, installation, commissioning, as well as on-site training on cold chain equipments to the countries under its Cold Chain Equipment Optimization Platform (CCEOP). As vaccines are usually supplied in very large volumes, the packaging configuration for vaccines meant for most institutional supplies is usually defined. Over the years, there have also been myriad of technological advancements when it comes to vaccine supply chain including track and trace systems for real-time on-route dynamic logistics planning and monitoring and management of any In-Transit Cold Chain excursions. In most of the institutional supplies, vaccine vial monitors (VVM) are used, which will change color if there is any temperature excursion. That said, there is a need for consistent improvement in this segment as about 20 million children still remain at risk from vaccine preventable diseases in the world due to under or no vaccination. Manufacturing process complexity arises from the need for rapid production and the prompt resolution of technical issues. Whilst traditional manufacturing processes are well established, these require time to scale-up. How can vaccine manufacturing be scaled-up? Rapid scaling-up of vaccine production can be a challenge. This can be primarily attributed to the fact that vaccines can be developed using different platforms like whole virion vaccines, subunit vaccines or viral vectored vaccines and now we even have nucleic acid based vaccines, which may require very different type of manufacturing units.The major factors, which need to be considered for scalingup are process and utility optimization as well as the availability of raw material and consumables besides numerous factors related to facility design, man-material movement and other resources. When it comes to process optimization, one would need to continue improving in the area of biochemical engineering and process quality controls, which can be integrated with computational sciences to develop mathematical models and predictive tools to identify critical process parameters or indicators, which can help to have a better design of experiments. Such an approach drastically narrows down the options as long as the critical process equipments are scaled up linearly to avoid more variables. In fact, many leading industries are already using these methodologies very successfully for traditional platforms and as more data related to newer vaccine platforms emerges, these tools will become even more powerful for scaling up these platforms. Today, there is an increased need to ensure patient safety. How do you see the industry working to attain the same? Vaccination is one of the most successful tools in reducing the burden of diseases and mortality in the world and WHO estimates that vaccination prevents around 3.5 to 5 million deaths every year. However, as vaccines are usually given to a healthy population, safety is definitely of paramount importance. In order to ensure safety, the vaccine developers
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