At Minaris Advanced Testing’s Navy Yard headquarters, BioBuzz kicked off its Philadelphia Insights to Impact (I2I) series with a frank conversation about the discipline that increasingly determines whether a therapy reaches the patient — and when.
Every therapy that reaches a patient passes through a gate most investors never see. Not manufacturing. Not the clinical protocol. The analytical lab — the scientists and methods deciding whether a product is safe, potent, and defensible enough to leave the building. That gate was the subject of BioBuzz’s first Insights to Impact event of the year in Philadelphia, hosted by annual sponsor Minaris at the company’s 140,000-square-foot Navy Yard site.
“Behind Every Therapy: Bringing Medicines to Market” drew a curated audience of industry leaders, founders, and ecosystem builders for two panels and guided tours of the Minaris testing labs. What the speakers made clear, from different angles, is that analytical science has moved out of the back office. In biologics, cell therapy, and gene therapy, it is now a strategic driver — of speed, of risk, of the relationship a developer builds with regulators, and of whether a program makes it.
A Combined CDMO and Testing Platform
Minaris CEO Orla Cloak, Ph.D., opened the evening by framing what the company has become over its first year as a unified brand.
“We are the combination of two legacy companies, Minaris Regenerative Medicine that was focused on CDMO and Wuxi AppTec Advanced Therapies which was both CDMO and biosafety testing. So we’re 100% American owned now. We are headquartered here in Philly.”
— Orla Cloak, Ph.D., CEO, Minaris
Minaris Advanced Therapies is a pure-play cell and gene therapy CDMO with sites in the U.S., Germany, and Yokohama. Minaris Advanced Testing, headquartered at the Philadelphia site that hosted the event, brings more than forty years of expertise in biosafety testing, viral clearance, and potency assay development. The panels returned again and again to a single premise: the testing strategy a developer adopts on day one shapes every downstream decision — manufacturing changes, comparability exercises, regulatory filings, and ultimately the BLA.
Why Analytical Science Is Central to Life Sciences Success
Moderator Joe Payne (JEP Consultant Services) opened with a provocation: if a room of investors walked in right now, how would you convince them analytical science is mission-critical? The panel — Catherine Willis, Ph.D. of St. Jude’s Children’s GMP, Jennifer Hayne of Catalent, and Therese Choquette of Swiss biotech Tigen Pharma — converged on a thesis that held for the rest of the night.
For Willis, whose team manufactures CAR-T for pediatric patients with five-day turnaround times, the stakes are literal: analytics determines whether a patient next door gets the therapy they are already scheduled to receive. She recounted an out-of-specification result on the day of a scheduled infusion where her team’s analytical rigor allowed them to perform investigational testing, file a variance with the FDA, and get the product to the patient inside the eligibility window.
Hayne was candid that when she raises analytics with investors, the response is “pretty lackluster” — but the economics run the other way from how most programs budget them. Analytical investment early is the single most reliable way to de-risk a program later: shorter comparability exercises, faster tech transfer, fewer late-stage surprises. Choquette, part of the Novartis team that took CAR-T from its UPenn roots to commercial, framed the same idea as building a thick “book of knowledge” about the product. Her advice from deep experience: never throw anything away, not even the failures. The bad cells teach the assay what bad looks like.
“We need to build the book of knowledge of the product, and without analytical testing and characterization, we cannot do that.”
— Therese Choquette, CTO, Tigen Pharma
Asked what the industry is most missing, the panel was unanimous: efficiency across the field, not inside any one company. Standardized flow cytometry panels, shared automation, and more pre-competitive collaboration would move every program forward faster.
Modernizing Analytics in a Rapidly Evolving Landscape
Moderator Audrey Chang, CMC Scientific Advisor at Minaris Advanced Testing, was joined by Christopher Larson (VP of QC at Castle Creek Biosciences), Andrea Moore (VP of Analytical Development and QC at AskBio), and Joe Newcome, Senior Director of Analytical Sciences at Minaris. Chang opened on recent regulatory guidance that has moved deliberately away from prescriptive language. For Moore, it opens dialogue with the agency and creates room for new technology. For Larson, it introduces a subtler risk: when regulation no longer says “you must,” the CFO is harder to convince, and work that used to be mandatory competes for funding. For Newcome, speaking from the service-provider seat, flexibility adds complexity — one client’s regulator has heard one thing, another’s has heard another, and the testing partner has to navigate both without a single rulebook.
The AI conversation was candid. Larson pointed to a recent FDA warning letter in which a firm admitted using AI to generate test methods, batch records, and SOPs without human review — and then explained a missed process validation on the grounds that the AI had not told them to do it. Machine learning is not new to QC, the panel agreed; flow cytometry gating and HPLC peak detection have been doing it for decades. The governance principle is unchanged.
“You have to understand what you’re putting into it. It’s only as good as the data. And if no one’s actually looking at what it’s pumping out, you’re just setting yourself up for failure and warning letters.”
— Joe Newcome, Senior Director, Analytical Sciences, Minaris Advanced Testing
On potency, Newcome was direct: do not wait until Phase 3, and do not wait until you are told. Early-phase programs may need more than one assay while mechanism of action comes into focus. Asked how close the industry is to a push-button “QC lab in a box,” the panel was collectively skeptical — combining technologies creates diagnostic problems when one assay misbehaves and needs to be isolated rather than untangled from four others inside a single black box. An audience question on tool developers and standards drew one of the sharper exchanges of the night: Larson placed the responsibility on innovators, arguing it is not some other body’s job to build the reference standards a new modality requires. Chang agreed — standards are universally acknowledged as critical and chronically under-resourced.
What the Room Took Home
- Analytics is strategy, not overhead. Programs that treat release testing as a gate to pass at the end pay for it in time and risk.
- Build the book of knowledge — and keep every page. Characterization data, failure modes, and retained samples compound over the life of a product.
- The ecosystem’s biggest gap is shared infrastructure. Standardized panels, pre-competitive collaboration, and funded reference standards would shorten every timeline in the room.
This was BioBuzz’s first Insights to Impact event in Philadelphia this year, and a strong opening to the series. Thanks to Minaris for hosting, to partner sponsors Conner Strong & Buckelew, CRB, Heffron, Kymanox, and Workforce Genetics, and to the panelists for bringing their knowledge into the room.
Learn more about Minaris Advanced Testing at minaris.com.
