Greenfield CDMO Sees Digital Validation as a Competitive Advantage



Implementing a digital validation lifecycle management solution before a company opens its doors is rare, but then again, so is Theragent. Fully embracing its greenfield status, the startup biotech contract development and manufacturing organization (CDMO) was determined to take advantage of the unique opportunities building from scratch offers, namely the chance to leverage digital automation and other smart factory capabilities from the outset and bypass the challenges mature companies must contend with like outdated legacy systems and processes. These challenges can clog the product pipeline, delaying innovation and the delivery of life-saving therapies.

In the highly competitive CDMO space, expediting speed-to-market is a top priority. Theragent’s executive team recognized that the efficiency and productivity gains of being a digital-first organization would offer a substantial competitive advantage.


Problems with Paper

The validation requirements for a startup CDMO are massive. When validation is conducted on paper in disparate systems through manual processes, it requires enormous time and effort. Mistakes caused by human error are unavoidable. Delays are virtually inevitable.

“Validation plays such a key role in any new life sciences company, and I know from experience that paper-based validation is a huge bottleneck. ‘I need this piece of equipment, or I need this cleanroom, or I can’t store my materials in the freezer because it hasn’t been validated’ are common complaints —everybody is waiting on validation,” said Jeff Masten, Theragent’s Chief Operating Officer. “From day one, we were committed to resource validation properly so these delays wouldn’t happen.”


Unmatched Control and Standardization

Masten and his team chose the ValGenesis Validation Lifecycle Management System (VLMS) over other validation tools because he was impressed with its robust auditing capabilities and the level of control and standardization the system brings to the entire validation process. He believes standardizing on the same digital validation tool used by 30 of the world’s top 50 life sciences companies will set Theragent apart and help them meet customer expectations of on-time product delivery in compliance with regulatory requirements and quality expectations.


Building the Facility and Workforce of the Future

For Theragent, the benefits of digitization are not limited to accelerating compliance, innovation, and time to market. “We’re attracting some of the best talent in the industry, and I believe our commitment to Pharma 4.0, and digitization is a big part of that,” said Masten. “Our employees don’t want to push paper. They want to change our world and transform medicine. We want to make sure they have the tools they need to do it.”

Read the full case study to learn more about how the ValGenesis VLMS helped Theragent accelerate its validation efforts without compromising safety or compliance.


The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.