July 14, 2020
Reducing bottlenecks in COVID-19 vaccine manufacturing
How biopharmaceutical companies in the maze to find a vaccine against COVID-19 are relieved from agile suppliers with simplification processes and open mindsets, such as Single Use Support. Troubleshooting with fast, safe, and scalable single-use solutions has proven its effectiveness in extremis.
First, there was a life science industry that was built up with rigid structures, inflexible processes, and timelines over decades.
Then, with the pandemic outbreak, the drive from biopharma giants accelerated. All resources have been activated to fight for an immediate remedy and to help saving people’s lives. Waiting was not an option. The motivation of staff was enormous and required increased workload of staff with agile working patterns. Working day and night on one common vision to end the spread of the pandemic while news report from further increase of infected and deaths. However, working faster and harder did not necessarily help to overcome all challenges.
Straight-forward thinking, flexibility, and the opportunity for scalability in all directions and yet maintaining maximum patient safety was in demand. Additional challenges such as travel restrictions, lockdowns, static mindsets of companies required simplification of processes. Business partners needed troubleshooting abilities and a sense of customization in their corporate DNA already since its foundation to be of valuable support. Therefore, the industry relies preferably on agile partners with common goals. Out of these reasons, two frontrunning companies in the fight against COVID-19 selected Single Use Support, as supplier of supportive elements. A relief to bundle the researchers’ forces to what it is about: research: “Wonderful to see Single Use Support working together with us to support the common good.”
Starting off in clinical studies
The first test persons receive the injections of the potential vaccine against covid-19 in record time. For safe and sterile transportation of the testing vaccines, the liquids are being filled into single-use bags. To not jeopardize the loss of the highly valuable vaccine these bags are being protected from external influences by RoSS shells and RoSS.KSET by Single Use Support as robust secondary packaging. The drug substance activity is being maintained by fast freezing with the plate-based lab scale freezer.
FDA introduces fast track approvals
Luckily, regulatory bodies do not stop biopharma to thrive for the cause, as the FDA paves the way to vaccine approvals in the fast track. For upcoming studies, the researching companies soon scale up from vials to large volumes at full speed and need equipment to compensate the larger scales.
Clinical phase 3 trial is set. Equipment for bulk drug substance handling is ordered. One whole process stream that is seamlessly integrated into the company’s operational system: in the heart of it, the RoSS shell protects the precious potential vaccine in single-use bags, RoSS.FILL to fill and drain the drug substance fully-automated into single use bags in less than 60 minutes and large scale Freeze/Thaw Platform (RoSS.pFTU) to freeze down to -80°C per batch of up to 200 liters for transportation and to thaw after safe receipt at the fill & finish site . With COVID-19 high priority and fast time delivery, the machines will arrive on time. Instead of 6 months, Single Use Support dedicated to a delivery weeks earlier. Commitment paired with flexibility and the mindset to implement such a process within short time at the vaccine manufacturing site. The fast pace of the equipment helps to diminish downtime of production. More vaccines can be handled in shorter time. The companies’ goals of a timely vaccine maintain on track.
But how to put everything into operation on-site?
The equipment is on its way. But no technician can follow. Travel restrictions make factory acceptance test (FAT) in Austria and site acceptance test (SAT) in the USA void. Virtual meetings to deploy and commission all machines are the operational remedy. Day and night support despite time differences of 6 hours between the USA and Austria.
Also, IQ/OQ performance will be conducted – virtually – for proper qualification and validation tests according to international regulations. Not only regulatory compliance by GMP and CFR Part 11 is secured. Also, COVID-19 local compliance standards are met. With ongoing assistance and consultancy, hurdles are being taken instantly.
The challenges in handling with highly valuable drug substances is no longer a challenge of the researching companies. The end-to-end solution to manage the logistics of drug substances delivered from Single Use Support has fit seamlessly and is already fully integrated into the company’s environment. Project management on eye-level, appreciated flexibility and agility make it run as fast as it can get.
The shared vision to revolutionize the biopharma industry with innovative, fast, safe, and scalable solutions has even fostered the collaboration with Single Use Support. Whenever there might be at a dead-end street, there is a chance for an even simplified way with smaller risk and increased scalability. The biopharma giants can set its full focus on fighting Covid-19. All forces are needed to be successful in the combat. The foundation for it has been laid.
Midst the fight against Covid-19 innovations and agility have truly increased. Faster development has pushed the boundaries and might spill over to other research therapies. The winner of the race will be patient’s health.