“Biotechs need flexibility and have limited budgets, while big pharma looks for long-term partnerships, reliability, scalability, and new technologies.”
Luis Berrade, Senior Director of Global Biologics Testing Sales at Charles River Laboratories, has spent his career helping pharmaceutical and biotech companies bring therapies to market faster and safer. With a PhD in medicinal chemistry and experience spanning both contract manufacturing and testing services, Luis now leads Charles River’s global biologics testing commercial strategy, working with companies of all sizes to navigate the complex regulatory landscape.
In an episode of the PharmaSource podcast, Luis shares his insights on when sponsors should start thinking about testing strategy, common mistakes that create bottlenecks, and how emerging technologies like next-generation sequencing are reshaping the biologics testing landscape.
Start Testing Planning Pre-IND
Many sponsors don’t prioritize testing strategy until it becomes a bottleneck. Luis emphasizes that timing matters.
“Ideally, pre-IND, especially for characterization and release methods, they should be thinking about it before they go into the clinic,” Luis explains. “We face challenges when clients don’t think about whether methods can be validated according to ICH guidelines. They may develop something in a research center or in-house, then realize they cannot validate that method and cannot use it for release.”
Charles River helps optimize methods from both regulatory and scientific perspectives to ensure they can eventually be used for their intended purpose—typically the release of drug substance or drug product.
Common Strategic Mistakes
Luis identifies several pitfalls that complicate development programs.
“Some companies place different assays with different service providers and end up dealing with several vendors for drug substance and drug product release—that becomes a nightmare,” he notes. “We can do pretty much everything under one roof.”
Another frequent issue involves inadequate quality-by-design approaches. “Sometimes we need to optimize methods because they didn’t think properly about the design of the study or conduct a proper quality-by-design approach,” Luis says.
Vendor fragmentation and insufficient method planning during early clinical stages create unnecessary complexity that companies could have addressed upfront.
Supporting Big Pharma and Emerging Biotechs
Partnership needs vary significantly based on company size and resources.
“With biotechs, they need flexibility and usually have limited budgets,” Luis observes, “while big pharma looks for long-term partnerships, reliable programs they can trust, scalable capacity, and new technologies.”
Small companies often worry about getting deprioritized at large providers. However, Luis explains, “we want to be a solution provider, not just a service provider. We don’t neglect small companies. Their treatments could save lives, so they’re important for us too.”
The key differentiator of a successful partnership is open communication. “Trust and communication are critical,” Luis emphasizes. “The more information we get about what clients need and when they need it, the better we can tailor our approach.”
New Modalities and Regulatory Changes
The biologics landscape has evolved dramatically, with antibody-drug conjugates, gene therapies, and cell therapies creating new testing requirements.
“Every modality has different requirements,” Luis explains. “For gene therapy, you need new methodologies and assays, and we see more urgency in getting results. For cell therapies, the timeline is critical because the shelf life is very reduced.”
Charles River supports clients through rapid technologies for autologous products and helps them develop or validate methods for in-house testing when necessary.
Regulatory expectations are also shifting. “The main change has been implementation of the ICH Q5A(R2) guideline,” Luis notes. “NGS has become much more popular for viral safety and genetic characterization. Companies can also leverage prior knowledge for viral clearance validation, helping reduce the scope of studies, cost, and material required.”
Global Presence with Harmonized Protocols
Operating across regulated and semi-regulated markets requires flexibility.
“In regulated markets like the US, Europe, and Japan, testing requirements are similar,” Luis says. “We offer harmonized protocols compliant with USP, EP, and in some cases Japanese and Chinese pharmacopoeias.”
For semi-regulated markets, the approach adapts based on client needs and specific regulatory requirements.
Charles River’s global footprint, with labs in both Europe and the US, combined with its comprehensive service portfolio covering method development, qualification, validation, and characterization, positions the company as a long-term partner for sponsors navigating complex development pathways.
“It’s about being a partner clients can trust,” Luis concludes. “Many of our clients are loyal to Charles River because of their positive experiences working with us.”
