Emerson Briefing Note
Axendia was recently briefed by Kristel Biehler, VP of Life Sciences, and Bob Lenich, Business Director of Process and Knowledge Management at Emerson. The company recently announced the formation of a Life Sciences Executive Board to develop standards for digitalized recipe lifecycle management during tech transfer, which in turn, will help companies navigate this activity during drug development more efficiently and much more quickly. By optimizing the recipe tech transfer process and enhancing operational efficiencies, these initiatives also enable companies to further protect their margins in their efforts to mitigate the impact of price controls introduced by the Inflation Reduction Act.
Uncovering the Challenge
Challenges during tech transfer – the formalized process for moving manufacture of a treatment from one facility, scale, or development pipeline phase to another – continue to plague the pharma and life sciences industry, contributing to the protracted timelines in getting medicines to market. The longstanding grip that paper and manual-based processes have had on these organizations has persisted despite the growing number of digital tools available. As more work has been done to understand and address the inertia, it has become increasingly clear that the lack of a common language and set of industry manufacturing specification standards has been one of the biggest culprits of a fragmented ecosystem. Reconciling this roadblock and cohesively progressing a digitally transformed tech transfer would enable companies to greatly enhance productivity and efficiency, bringing a single source of truth across the functional groups and partners involved.
Industry Stewardship
With the recognition that minimizing cumbersome and lengthy tech transfers is unlikely to happen without clearly defined industry standards, Emerson publicly announced the formation of a Life Sciences One-Click Technology TransferTM Board on Oct 4, 2023. Companies represented on the Board include FUJIFILM Diosynth Biotechnologies, Merck and Pfizer, who will collectively advise on integrating across the recipe transfer process in collaboration with Emerson’s new Singapore-based Life Science Technology Transfer and Software Research Center. The Research Center will assimilate those inputs as well as other industrial automation standards, to design, develop and verify the new software technology. Standardization paves the way for acceleration of digital technology adoption and ultimately digital transformation.
“The generations of life sciences expertise in the current partners of the One-Click Technology Transfer Executive Board will help ensure successful digitalization solutions also promote scalability, standardization and best practices as they influence the coming decades of life sciences innovation and benefits for patients.”
–Lars Petersen President and CEO, FUJIFILM Diosynth Biotechnologies
Emerson is having similar conversations with other end user companies about joining the Board and according to Bob Lenich, will additionally “broker collaborations with industry organizations like BioPhorum, NIIMBL [National Institute for Innovation in Manufacturing Biopharmaceuticals] and subsequently, with industry standards organizations like ISA [International Association for Automation] to leverage this development for the benefit the industry.” At some point, Emerson would ideally be able “to enlist other technology partners to participate and apply their expertise to this initiative where it makes sense,” says Kristel Biehler. Details are yet to be worked out, but the sentiment demonstrates the need for support that extends beyond Emerson and the Tech Transfer Board. With so many vendors in this space, there is incentive for everyone’s involvement and agreement that any new technology must be easy to integrate into the myriad of existing digital ecosystems.
Digitally Transforming Recipe Management Across the Lifecycle
With the push for digital transformation, the overarching task to affect change can seem particularly daunting when one considers the opportunities for improved efficiencies at each stage of the product lifecycle. There is the traditional aspiration to digitally integrate these stages horizontally, but as Bob Lenich states, “Where Emerson is tackling this issue differently than other solution providers is two-fold: we are focused initially on recipe tech transfer, specifically, and we are intent on enabling simultaneous integration both horizontally and vertically.”
Simplifying “Horizontal” and “Vertical” Transfers via a Standard Product
Image Source: Emerson
The approach requires discipline, and according to Lenich, “it allows us to focus on the transfer process – what is needed to make product at each development stage and how to tell the various execution systems at each stage how to do it.” In this case, it’s less about the manufacturing and process data collected before or after production – it’s about enabling a robust and sustainable, digital recipe management process either in-house, between sites or with external partners at each phase of development. Improvements of the recipe transfer process will yield significant time, resource and cost-savings and will inevitably impart time and cost-savings to other dimensions of the product lifecycle such as regulatory submissions.
Case Study: Achieving the 1-Click Tech Transfer
The team from Genentech’s South San Francisco Clinical Supply Center presented on their success with streamlining recipe management at Emerson Exchange Immerse in October 2023, following up on the facilities selection in May 2023 as the ISPE Pharma 4.0 Facility of the Year (FOYA) winner.
Genentech characterized the near-term value of one-click tech transfer as significant time and cost savings, with recipe transfer timelines reduced by more than 3 months . Longer term, the value will be in implementing an enterprise recipe management system and process knowledge solution with the ability to manage a product over its entire lifecycle. Standardization is an integral design component of the initiative and includes the creation of manufacturing recipe standard object templates that can be easily translated to templates for bills of materials, bill of parameters and the like for use in execution systems. Reconciling common elements like units of measure and naming conventions improve outcomes and pave the way for easier integration across systems both within network and among partner organizations. With standardization, data exchange is easier, fully digitalized and less prone to error. The Genentech team has tested this system with different Manufacturing Execution Systems (MES) with success, an accomplishment applauded by the industry, given that the ability to integrate solutions across multiple system scenarios is what the industry has voiced as an ongoing need.
In Brief
Simplifying and streamlining recipe tech transfer is a crucial element in accelerating drug development and commercialization timelines. The notion that any company will have the luxury of selecting a one-size-fits-all system is archaic at this point. Digital ecosystems vary widely across the industry, and with the push for recipe standardization, Emerson and their partners on the Life Sciences Executive Board are tackling an underlying issue that has long hindered adoption and implementation of digital technologies.
We will continue to provide updates on Emerson as they become available.
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