As our growth continues to soar, we’re excited to see new sectors of the drug development enterprise tapping into the power of QbDVision and Digital CMC. They now include our first collaboration with a contract development and manufacturing organization (CDMO): Vernal Biosciences, an emerging leader in mRNA manufacturing.
New CDMO collaboration takes QbDVision to the cutting edge of contract development and manufacturing
The global pipeline is rapidly filling with cell, gene, and other biologic therapies – technically challenging molecules that require highly specialized development and manufacturing solutions. Vernal Biosciences is part of a new generation of CDMOs built from the ground up, to meet the growing demand for the complex cell-based and genetic material these “third wave” R&D programs require.
Vernal’s focus: creating a simple, scalable platform for on-demand production of high-purity mRNA.
One of the industry’s most in-demand drug substances, mRNA presents a unique set of technical, operational, and regulatory challenges for pharma and biotech companies. Vernal is working to solve them with a digital-first approach that enables rapid project set-up, highly efficient process development, and structured data curation from concept to clinic.
QbDVision is already playing a critical role in their platform strategy. Our product provides Vernal with a unified digital framework for their CMC processes development, teams, and data resources – as well as a springboard to greater efficiency, coordination, and agility across their organization.
Creating a modern process technology stack for biologic R&D programs
Disconnected legacy software tools and their data integrity risks were a non-starter for Vernal and their mission. Instead of adapting conventional methods to complex biologic material, they’re taking a ground-up approach to building a CDMO optimized for state-of-the-art R&D initiatives.
At the heart of that strategy: an array of modern software platforms like QbDVision.
Our software provides Vernal with a fully digital way to collaborate, both within their own team – on key process, risk, and analytics workflows – and also with their customers. QbDVision’s structured knowledge management framework provides an ideal workspace for organizing, tracking, and sharing the critical information that Vernal’s process development experts need, and that their customers will rely on for regulatory submissions, trial initiation, and eventually tech transfer and scale-up.
"More and more life sciences companies and outsourcing partners are discovering that CMC software is an essential tool for twenty-first century drug manufacturers. Transformation isn’t on the horizon for our customers. It’s here, and it’s picking up speed."
Vernal’s leadership team is already seeing the benefits in their processes, timelines, and outputs.
“QbDVision provides the operational foundation of our mRNA platform,” says CEO and Founder Christian Cobaugh. “It provides the knowledge management structure we need to embed quality best practices in every experiment, to make smarter decisions at every step, and to provide our customers with a seamless, fully contextualized process development history that they will need to show their regulators.”
Collaborating with customers along the way – and handing off crucial deliverables at submission deadlines – is the goal for Vernal. “I want to tell our customers that there’s one section of their IND that they never need to think about,” adds Cobaugh, “And that’s CMC. For that, there’s QbDVision.”
Accelerating the next generation of breakthrough biologic therapies
For Vernal, adopting QbDVision is a crucial step in helping innovative drug development teams to access the high purity mRNA they need to advance their early-stage drug development programs.
For us, it’s exciting to see how collaborations with CDMOs like Vernal will continue to evolve and expand our fast-growing user base. Complex biologics – not just mRNA, but also viral vectors, fusion proteins, biosimilars, and more – are already reshaping the future of the biopharma industry. This new generation of bioengineered molecules demands a greater level of sophistication in the application of quality-by-design principles and best practices.
And that’s in our DNA.
“QbDVision provides the knowledge management structure we need to embed quality best practices in every experiment, to make smarter decisions at every step, and to provide our customers with a seamless, fully contextualized process development history that they will need to show their regulators.”
Learn more about our new growth in biomanufacturing.
Adoption of QbDVision continues to accelerate across the life sciences industry, as Digital CMC gathers momentum both with drug developers and their networks of vital outsourced partners. We’re excited to see where this trend will open new opportunities for us to partner with innovators like Vernal Biosciences – and to share more updates as new collaborations take shape.
For information about our product, team, and commercial growth in multiple industry sectors, contact us today.
Vernal Biosciences
Vernal Biosciences is an mRNA manufacturing company that provides high purity mRNA, from concept to clinical trials, on a transactional basis. By reducing barriers to research and clinical mRNA manufacturing, Vernal enables great ideas, present and future, for the application of mRNA. The company is experienced at overcoming the bottlenecks involved in mRNA-based R&D with reliable, high-purity manufacturing, and an approach rooted in a quality-first culture and deep regulatory experience. Vernal currently offers manufacturing-research-use mRNA and is scaling its manufacturing process, which will become an advanced staging ground for clinical manufacturing projects.
