Case Study
VaxCyte reduces regulatory filing time by 25% with 1Platform4® Manufacturing.
The Challenge
VaxCyte is on a global mission to engineer high-fidelity vaccines that protect humankind from the consequences of bacterial infections. Their unique cell-free technology platform has enabled them to develop one of the most complex biologics ever attempted. They needed a way to organize manufacturing data to enhance data integrity and streamline regulatory submissions.
The Solution
VaxCyte selected 1Platform4® Manufacturing to be the central point of data collection for Chemical Manufacturing and Controls (CMC) related information. Using 1Platform4® Manufacturing, the CMC team records comprehensive lot genealogy information and ongoing stability data. The resulting data warehouse has reduced administrative overhead by 20% and accelerated submission times by 25% respectively.
Management
for Biotech
service
20%
Reduction in administrative tasks
By consolidating CMC data in 1Platform4® Manufacturing, internal stakeholders can self-serve, which has eliminated customer service requests and freed up 20% of staff time.
25%
Faster Submissions
The ability to generate stability tables and lot genealogy trees with the push of a button increases data integrity and has resulted in a 25% reduction in CMC submission time. Faster submissions mean faster filing, and faster to market.
1Platform4® Manufacturing is easy to use, intuitive, and adaptable. It allows us to capture CMC team data as soon as it is generated which promotes collaboration. The BioIT team worked closely with regulatory to generate data tables suitable for our regulatory submissions. This has streamlined our submission process considerably.
The Benefits
The implementation of BioIT’s 1Platform4® Manufacturing brought transformative benefits to VaxCyte, including:
CMC Team Benefits
CMC Data is stored centrally and the structure enforces data integrity. Staff inquiries have virtually disappeared which frees the CMC staff for other tasks.
Staff Benefits
Staff members can access important CMC Data themselves. Digital records are available with the click of a button which promotes collaboration and enhances quality.
Organizational Benefits
Regulatory submissions take substantially less time to assemble. This means filings can happen faster, which speeds time-to-market.