Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection
By Louis Garguilo, Chief Editor, Outsourced Pharma
Consider these two questions:
How do we select a CDMO?
How do we select a facility?
The second of these should carry as much weight as the first, but often does not. Let's try to change that.
To directly address the importance of specific external facility assessments and selection, we can study the best internal facilities.
Earlier we spoke with Roland Fabris, Managing Director, Site Head, Takeda Austria, about his facility winning the ISP Award in Operations – Facility Fit. That two-part elucidation starts here.
Now we travel across Europe and over to Ireland, to Eli Lilly Kinsale Limited which received the ISPE Award for Innovation and the Overall Award for Facility of the Year in 2024
You’ll find uncanny, instructive commonality between the Takeda and Lilly sites – one prefilled-syringe focused, and the other a peptide-processing platform.
For example, while both facilities are considered brand new, they reside at development and production sites with decades of experience. Both have transformed from predominantly small molecule to today’s advanced modalities.
Lorraine O'Shea, Associate Vice President and Plant Manager for the Small Molecule and Peptides facility at the Lilly Kinsale campus, says the ISPE awards are “a huge boost” to the professionals there, and throughout Lilly.
That’s more than a self-congratulatory reaction. As a sponsor, when visiting a potential manufacturing location, it’s will worth considering this question: Are the employees here genuinely upbeat, proud of their systems, equipment, and the opportunities they offer customers?
What It Takes To Upgrade Successfully
Fundamentally, before upgrading or building out a new facility, the organization at that location must exhibit a desire for innovation and improvement, and the commitment to make it happen.
Specifically at Kinsale, Lilly designed and installed a unique synthetic-peptide manufacturing platform, as well as implemented several new process and execution systems.
Among other novel improvements and integrations, “an original digital solution for material tracking and generating of accurate genealogy for continuous processing was developed, principally for the new hybrid-peptide continuous-manufacturing platform,” O’Shea explains.
She readily offers praise and appreciation for the external partners that are a part of creating and then operating a facility. (I tackled this subject previously: Who Handles Maintenance At Your CDMO? You Should Know.)
“The science and technology were internally delivered,” O’Shea says, “but absolutely, we also rely on our partners to help us to deliver these particularly significant capital investment projects.” She particularly acknowledges Kinsdale’s partners’ prowness for the design and construction elements of the project:
“Lilly is strong in the areas of clinical discovery and development, at coming up with new therapeutic compounds. The company is also very good at the science and engineering – how to make those compounds at scale, and how to revolutionize elements of that manufacturing process.
“But then as regards building facilities, designing them, construction, piping, automation type activities at that scale, that's where we leverage our strong partnerships to add external expertise.
“Some of them are global organizations that are preferred providers of Lilly; some are based locally. Together, these partners are utilized to transform our ideas into reality so we can produce our newest medicines for patients.”
Let's apply those thoughts to three questions of a CDMO you may be considering.
- Is the facility where your work will be done built for, and does it encase and readily support the equipment, technology, and workflow needed for today’s products?
- Is it assisted operationally with a skilled and stable workforce, and include supporting maintenance by competent partners?
- Is the facility a good fit – does it mesh with – your internal capabilities?
New Platforms For Your New Processes
We live in an era of novelty: emerging modalities and added compound complexity require creative development and manufacturing solutions.
From the start-up biotech to a company like Lilly looking internally at its own vast manufacturing network as well as its many CDMO relationships, selecting state-of-the-art facilities has never been more important.
And as I did with Fabris of Takeda Austria earlier, I inquire of O'Shea how a pharma organization with loads of manufacturing options, decides where to place work ,and for example, how it select facilities for upgrades and transformation.
“Among peptide manufacturers, batch manufacturing is well understood,” she begins her reply. “When the decision was made to build a new peptide plant, there was an ask about how can we do this differently and better?
“Essentially, that spurred groups in Lilly R&D and global engineering, in partnership with us here on the Kinsale site, to supply an answer.
“It drove the novel hybrid solution we have here. We put in place continuous chemistry solutions instead of batch. That brought a significant technology change.
“Secondary to a continuous platform, we then asked: How do you most effectively gather data? That drove some advanced analytical solutions. With continuous manufacturing, you have a lot of data generated. How do we manage and make the best use of it?
“In turn, that question led to thoughts about our material tracking system. How do we ensure that we always optimize all parts of our processes, based on that real time data?
“How we effectively combined these novel design elements was integral to Lilly receiving the ISPE award.”
What about the equipment required for a continuous manufacturing platform? O'Shea explains Lilly's global engineering teams were “very heavily involved” in the design of the equipment and its overall connectivity.
Like any new plant, she says, there are diverse new parts that must be designed, and others that already exist but must be optimized.
Lilly leveraged its strong relations with various equipment suppliers, and O’Shea again acknowledges a degree of “local assistance” from long-standing suppliers in Ireland.
What's It Mean To You?
With all this background, then, how does a drug sponsor select an external resource for its outsourcing needs?
We'll give O’Shea the final word here:
“We received the facility award because we embraced new science, new technology, new data approaches, and we have the workforce excited about the opportunity to put all that together.
“There are many elements that go into delivering any advanced pharmaceutical manufacturing plant. Ultimately, we are driven to deliver with quality and speed by our passion to improve the lives of the patients we serve.”
Use this as a benchmark against your perspective CDMO, and most importantly here, to decide how its facilities measure up.
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More specifically on the Eli Lilly Kinsale (Ireland) “continuous hybrid” model in part two.