Blueprint for Breakthroughs is a LinkedIn newsletter published by Adrienne B. Mendoza, MHA, SVP BioBridge Global and Chief Operating Officer (COO), BBG Advanced Therapies
Originally published on LinkedIn on July 29, 2025, Adrienne discusses the importance of scaling the process of advanced therapies while keeping GMP quality
In a recent article, I wrote about the access bottleneck in cell and gene therapy, the collection of the starting material (the cells), from patients and donors, and how to consider available solutions there.
Today I’ll highlight another side of the equation because even when the cells are collected, processed, and engineered to become the drug product, there’s still another major gate left to clear:
🧪 Can you prove it works?
In this industry, that means potency testing. And from my perspective, it’s one of the most overlooked bottlenecks in the advanced therapies field today. As new modalities emerge and regulators evolve expectations, the next frontier in potency testing will be speed, automation, and tighter integration between R&D and GMP environments.
🧭 Why Potency is a Pressure Point
Potency assays are the last mile before batch release, and the first thing regulators look for when reviewing how therapies are defined, measured, and scaled.
Yet across programs, it’s still common to see:
- Potency assays being developed late in the lifecycle
- Tests that are can’t validate under GMP conditions (e.g. proven reproducibility, repeatability, linearity, precision, and accuracy)
- Definitions of potency that differ by product, even within similar categories
- A lack of infrastructure to support routine, high-throughput potency testing as products scale
It’s an operational risk. One that can delay a trial, stall a launch, or limit commercial expansion.
💡 The Approach: Treat Potency Like a Core Capability
The BBG Advanced Therapies team built the organization’s contract development, testing, and manufacturing organization (CTDMO) capabilities with it in mind from the start. Here’s how:
🧪 1. Assay Development Embedded in Process Design
We support clients early – during process development, so potency assays are anchored to the mechanism of action and suitable for validation downstream.
→ That early alignment saves time, prevents rework, and builds confidence with regulatory bodies, on both sides of the IND.
🧰 2. GMP-Compatible from the Start
We ask: can this assay hold up to repeat use, under real-world conditions, and still deliver the insights needed for batch release?
Our labs are designed to accommodate that transition, not just with technical capacity, but with documentation, digital tracking, and staff trained for scale.
→ In other words, we don’t just make it work. We make it work at scale.
🤝 3. Cross-functional Coordination
Potency lives at the intersection of science, quality, and regulatory. That’s why our teams are trained to speak across those realms, ensuring that assay strategy, qualification, and release testing move in sync.
→ When the science is clear and the documentation tells the story, regulatory approvals follow more smoothly.
🧭 Why It Matters Now
As the field matures, therapies will live or die not just on what they do in principle, but on what can be proven in practice. That proof lives in potency.
And as therapies move from first-in-human to broader commercial use, we can’t afford to build potency in hindsight. We have to start with it.
Closing Thoughts
Access and potency are two sides of the same coin:
One determines who gets the therapy. The other determines whether it gets there at all.
At BBG Advanced Therapies, we’ve built around both, because getting a product to a patient means nothing if you can’t prove it’s potent, and having a potent product means nothing if it never reaches the patient.
If you’re designing for the future of CGT, potency isn’t just a test. It’s a strategy.
Ready to build a potency strategy that scales? Whether you’re in early development or preparing for commercial launch, our team at BBG Advanced Therapies is here to support you with purpose-built infrastructure, technical expertise, and a deep understanding of what it takes to release with confidence.
📩 Visit bbgat.org, or contact us!
