Whether large or small, vaccine studies differ from standard drug development in many ways. Sarah Slette, Sr. Study Manager, Vaccines & Novel Immunotherapeutics at Covance, explains the unique challenges her team faces and their solutions to rapidly deliver customized vaccine kits to sponsors' sites across the globe.
The benefits of a co-located, dedicated team
"When we created our purpose-built laboratory focused on vaccine and novel immunotherapeutic clinical solutions, we set it up with a co-located team of scientific and operational experts," said Slette. "This allows our study managers to work closely with the scientific and operational teams and quickly respond to our customers' needs."
Once the required contents of a kit are defined, these specifications are entered into a database and sent to the production team. Here, an automated system can quickly and accurately fill the kits with the vaccine-specific components and ancillary supplies.
"Unlike other CROs, we do our own kit production and don't outsource to third parties," said Slette. "As a result, we can accommodate rapid requests that require a lot of kits in a short amount of time, working directly with our team to optimize the production line."
Consistency is also important for study sites' efficiency. The kit production team has optimized their operations to create 4.6M kits each year with an impressive accuracy of 99.993%.
Handling specialized requirements
The automated kit production system can also handle specialized customer needs such as bagging of samples for multiple timepoint collections or specific custom work to meet assay requirements.
"For example, a flu vaccine study may have an item that is not in a typical kit," explained Slette. "Our team has the ability to reconfigure the production line to adjust for the new item and still produce the kits in the standard time."
A Scalable System
While the production line is known for its impressive high throughput capability, it is used for very specific custom work to meet unique requirements.
"We can do thousands of kits down to just a few kits to gather subjects' samples. Our ability to adapt to a study's needs gives our sponsors the flexibility they need," said Slette.
Once packaged, the vaccine kits are sent to the sites and the resulting samples can be tracked throughout their lifetime to ensure stability and data quality.
"Our logistics team is far-reaching and has full oversight of the couriers. If there are any concerns, we have the ability to quickly mitigate issues," said Daniel Weaver, Regional Logistics Manager of Covance.
"We can arrange for direct shipments from the site to the testing labs for any of your specialty testing that may have critical results for inclusion or exclusion or have a very short stability."
Even in the case of natural disasters or unforeseen events, the team has proven contingency plans in place and boasts a record of >99% sample receipt within stability to help sponsors maximize their sample yield.
Experience where it counts
From customized kits to data delivery, running a vaccine study requires a number of unique considerations. Sponsors often require rapid deployment of customized kits to support their efforts to accelerate subject enrollment and meet milestones faster.
With vaccine-specific expertise and dedicated logistical support, Covance has tailored its agile operations to fully support the needs of a vaccine trial, from enrollment and customized kits to data delivery. Working together, we know how move a study ahead and help sponsors realize additional savings in the process.