Questions with Efrain Guzman, Vice-President of Innovation and Business Development, NewBiologix
Q1: Many companies focus on scaling manufacturing, but you often start the conversation with analytics. Why is that?
In viral vector manufacturing, quality starts long before you get to large-scale production. One of the biggest challenges in rAAV manufacturing is knowing exactly what’s inside your viral vector — and what shouldn’t be there. That’s what our analytics platform delivers.
At NewBiologix, we can take samples at every step of the production process — just like a car factory has quality control checks along the assembly line — and quantify and qualify the contents of the preparation. The higher the proportion of functional material, the more potent the product, which means you can deliver less material to achieve the same therapeutic effect. That lowers cost of goods, increases yield, and ultimately ensures your CMC package meets regulatory expectations.
If you don’t start with quality analytics, you risk building your entire program on a shaky foundation — and you can’t fix that later.
Q2: NewBiologix uses both mass photometry and next-generation sequencing for rAAV characterization. What’s special about this approach?
Mass photometry is fast — in just a couple of hours we can determine the empty/full ratio of viral particles — a key quality metric early in process development. But that only tells you if there’s DNA inside; it doesn’t tell you what kind.
At NewBiologix, we also use Multidimensional PCR, an in-house method that’s rapidly becoming a next-generation standard in rAAV analytics. It complements traditional qPCR/ddPCR by providing deeper insight, higher resolution, and greater interpretability — particularly around genome integrity, which is crucial for both clinical efficacy and regulatory approval.
That’s where next-generation sequencing (NGS) comes in, providing the most comprehensive genomic characterization of rAAV vectors available today. It allows us to see not just how much DNA is present, but exactly what it is — spotting potential inconsistencies or unwanted elements at a base-by-base level.
The value isn’t in the equipment alone — many organizations can access similar tools — it’s in how we apply them. Mass photometry, Multidimensional PCR, and NGS together give us a multi-layered view of vector quality: from rapid capsid ratio checks, to targeted genome integrity analysis, to full genomic auditing. It’s like cooking: you can give two chefs the same tools, but the one with the right expertise and recipe will produce a much better dish.
Q3: How does this translate into real-world benefits for your clients?
When your vectors are high quality and free from unwanted elements, you get more potency per dose. That means fewer doses are needed, which reduces cost of goods and increases the number of doses you can produce from a single batch.
You also avoid wasting time and resources. If your starting material is poor quality, you could be spending months — and significant budget — only to find out later that your vector wasn’t suitable for the clinic. Our analytics give clients confidence and assurance in their product from the very start, which is critical both scientifically and financially.
And because regulatory agencies are increasingly scrutinizing vector quality, our approach also helps clients be prepared for those discussions. We’re essentially giving them the cornerstone tools for establishing successful CMC quality and processes.
Q4: If you could give one piece of advice to companies developing viral vectors, what would it be?
Start with quality assurance. Build integrity into your product from day one. The more you know about your vector early, the stronger your program will be.
In this field, quality isn’t just a box to tick — it’s what determines whether your therapy will reach patients safely, effectively, and at a scale that makes it accessible. At NewBiologix, we give clients the confidence to move forward knowing their product high-quality, consistent, and safe for patients.
Learn More: https://145175225.hs-sites-eu1.com/quality-assurance-matters
