QbDVision® Briefing Note
Axendia was recently briefed by the executive team at QbDVision® on its unified digital Chemistry, Manufacturing and Controls (CMC) platform. “Our focus is on breaking down the digital divide by simplifying and harmonizing four key areas: Process Management, Tech Transfer, Control Strategy, and Resource Management,” said Luke Guerrero, Chief Operating Officer. To this end, QbDVision offers a structured data platform in the cloud to vertically integrate CMC knowledge and manage workflows over the entire product lifecycle to accelerate therapies to patients.
Pricing Pressures Drives Digital Tech Transfer Adoption
Axendia research shows that accelerating Tech Transfer is a primary focus for organizations in light of pricing pressures. However, Tech Transfer goes beyond moving and scaling up/out manufacturing capabilities.
Luke noted that “Organizations are starting to recognize that Tech Transfer is more than just a manufacturing process, especially when it comes to transferring into manufacturing. They are trying to make sense of the end-to-end digital workflows and recognize that living in that construct requires working with paper. So, our solution is more about mapping and really being able to work back and forth between digital electronic and paper.”
“Many think of Tech Transfer as the translation from late-stage development into commercial, but there are a lot of smaller and equally important Tech Transfers that happen along the way, especially across clinical development. The knowledge gained in these early stages sets a critical foundation for the broader program. The platform we are building and driving, combined with the integrations that we are establishing, helps teams with Tech Transfer throughout the entire lifecycle. This information speeds up in the translation from development ultimately into commercial, and is further accelerated with the layer of MES integration coming in, which we are supporting now as well,” commented Yash Sabharwal, President and CEO.
Barriers to Adoption
Axendia’s research shows that overcoming organizational inertia is one of the biggest barriers to change in life sciences.
Luke explained, “It’s the biggest calamity of all, the transition from a lack of doing anything to all of a sudden starting to do something, creates a lot of activation energy and sometimes it’s vectored in the wrong places.” Companies need to settle on the ways of doing things and promulgate those through the people that are actually doing it. Luke continued, “There is no simple tool that solves that kind of problem. That is a knowledge management problem. Looking for a solution that does this part of Tech Transfer is not going to be successful because the benefits of digitization come over time for the whole, not over one specific area.
“Where to start is the challenge.” As Yash pointed out, “There’s a heavy focus on digitization of primary data because, for many scientists and people, that’s just a more practical problem. So, if they’re trying to figure out how to move away from notebooks, lots of times, they’ll say, ‘we’re just kind of focused on implementing an ELN’ or something like that. So again, it’s solving a narrow slice of a particular operational issue. It’s not thinking about overall operational excellence or efficiency.”
The Elevator Schpiel for Action
“When talking to executives, you need to focus on things like operational efficiency,” said Yash, “You’re discussing things like accelerating a specific workflow that may have a lot of risk. i.e., integration with MES. We’ve demonstrated that you can go from a six-month timeline to a one-month timeline, and that type of efficiency is something that nobody can ignore. What we’re trying to do is show that the efficiencies gained from going in this direction are so significant that you can’t ignore it.”
Yash also mentioned that companies with a high volume of churn amongst employees, or onboarding new employees that lack experience,” the idea of institutional knowledge around templating and embedded workflows that people can just follow, those are conversation pieces being had at the executive level.”
Acceleration Through Integration
Axendia research shows that as biopharmaceutical companies look for opportunities to accelerate innovation cycles, the management of products across the complete lifecycle to support continuous improvement is a strategic imperative.
MES integration to facilitate the creation of standard batch records is critical to enabling digital Tech Transfer. This is an important piece of QbDVision’s new offerings. According to Yash, “this is a bit of a chicken and egg question. I think one of the things you could argue is that the reason there are all these different variations is because of different equipment for different plants and so forth.”
Part of the problem is the fact that there is little standardized and structured information from development to support Tech Transfer and manufacturing execution. As a result, there is often a lot of interpretation and guesswork to scale up what happened in product development into MES recipes to support commercial operations. That interpretation has led to different versions of Unit Operations and batch records as different people implement the same operation across sites and products.
Yash added, “I think one of the reasons that the MES integration came to the forefront this year is that some of our integration partners came to us and said, well, we’re getting a lot of questions about how we get to digital earlier in the lifecycle? Because if we can do that, that can help with the problem of creating a more standardized set of information that can feed into the later stage implementation. Then adjustments that may get made from one site to another, may just be truly site-based and not because recipe writers are interpreting things differently.”
Today, the steps needed to get information from product development to enable an author to create a Batch Record rely on very cumbersome, time-consuming, and manual processes. They rely on manually generated tables, lists, documents, and spreadsheets.
“One of the groups that we work with has done a nice job of building a demo showing how ‘this is the old way to do it, and here’s the new way to do it’. It literally leaves people speechless – the Excel tables are gone!” added Yash.
In Brief
As pricing pressures continue to drive the Biopharma industry to accelerate time to market, Digital Tech Transfer is a primary focus. However, the industry is recognizing that Tech Transfer goes beyond moving and scaling up/out manufacturing capabilities. It requires integrated end-to-end digital workflows across the product lifecycle.
As the Biopharma industry transitions to the Right Side of the Digital Divide, QbDVision’s focus on simplifying and harmonizing Process Management, Tech Transfer, Control Strategy, and Resource Management is well-positioned to support this transformation.
We will continue to monitor QbDVision and provide updates as they become available.
To discuss how this initiative impacts your organization, contact research@axendia.com to schedule an Analyst Inquiry on this topic.
The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.