Expression Therapeutics, Inc. is a fully integrated clinical stage gene and cell therapy company developing novel, potentially curative, therapeutics for deadly childhood and adult genetic diseases.
The company recently built a 43,000 sqft state-of-the-art facility located in Westchester, Ohio to add in-house manufacturing capabilities for its product portfolio.
In this facility, Expression Therapeutics is able to produce lentiviral (LV) and adeno-associated viral (AAV) vectors, cell therapy products and recombinant proteins to speed up development of their clinical programs.
As the company began the planning of their new facility, they decided they needed to implement a modern quality management system that didn’t rely on paper. The company’s major investment in their Ohio operations represented a new phase of growth and Eric Day, Director of Quality Assurance, saw document control efficiency as their biggest challenge.
Efficiency was the top priority. We needed a system that would cut down on the amount of time that it took to move a document from creation through review, approval and issuance.
Our previous experience with paper meant this would take days, weeks, sometimes months to occur.
Expression Therapeutics met with multiple eQMS vendors evaluating capabilities, pricing and customer support.
Ultimately, they chose Qualio over other platforms for the combination of powerful functionality and usability. The company believed Qualio was the best way to move faster and more efficiently.
As a data-driven organization, visibility into KPIs and metrics was a key requirement. The company previously tracked deviations, CAPAs and training in spreadsheets and hard documents. With Qualio, the team could unite their data in one place and proactively pinpoint areas to improve.
We were impressed with the ease of use from validation to implementation.
Our team was excited by how easy it was to use Qualio, create documents, templates and events, and follow deviations and CAPAs to closure.
Qualio helped Expression Therapeutics hit the ground running with an optimized digital approach to quality as they opened their new facility.
In addition to helping the company stay on top of remote QMS work, implementing Qualio’s eQMS has helped in a string of key areas:
1. Saving time with more efficient processes
With Qualio, Expression Therapeutics has been able to realize their goal of being a more efficient and quality-centric business.
The quality team no longer spends time on laborious document management thanks to Qualio’s digital repository underpinned by compliant e-signatures.
In terms of getting documents created, reviewed and approved, that can now be done within a matter of a few minutes or hours.
This speed has had a very large impact on our staff.
2. Paper is in the past
Making the transition from paper to electronic documents can be complex. Expression Therapeutics relied on the Qualio+ team to aid in the digitization journey and build system document templates to drive a consistent, controlled quality approach.
A normally arduous process was described by the quality team at Expression Therapeutics as “in a word, excellent.”
3. Consistent, hands-on partnership
Whether it’s questions about transitioning from paper or working towards audit readiness, Expression Therapeutics enjoys ongoing support with its Qualio+ subscription.
For example, the team needed help creating events to track items beyond typical deviation and CAPA activities, such as cleaning schedules and procedures. Targeted support from Qualio’s team of experts made it happen.
During the evaluation phase, Expression Therapeutics were drawn by Qualio’s commitment to quality and support, and were happy to see that commitment fully materialize as a customer.
With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world.