Charles River Laboratories

Luis Berrade serves as the Senior Director of Sales for Biologics Testing at Charles River, bringing more than 14 years of experience in the biotechnology sector. He earned his Ph.D. in the U.S. before beginning his career at a European Contract Development and Manufacturing Organization (CDMO), specialising in biologics manufacturing and testing. Berrade later joined Charles River Laboratories, where he advanced from a Cell Specialist role to his current global leadership position.

Throughout his career, Berrade has developed deep expertise in biologics development, with a particular focus on viral safety and clearance strategies for recombinant proteins and advanced therapies. His combined experience in CDMO operations and testing services provides him with a unique perspective on the complex challenges companies face in ensuring the safety, quality and efficacy of their biologics.

In an interview with Pharma Tech Outlook, Berrade emphasises the importance of biosafety in biologic manufacturing and the advanced technologies that are redefining biosafety testing.

Navigating the Three Pillars of Biosafety in Biologics Manufacturing

For organisations manufacturing biologics—especially complex products like antibodies, vaccines and advanced therapies—biosafety isn’t just a regulatory checkbox. It’s a multilayered challenge built around three critical pillars—raw material safety, rigorous testing and viral clearance.

Raw materials are the foundation of any biologic, and their safety is nonnegotiable. Companies must thoroughly evaluate every component, screening for viral, microbial or other contaminants that could jeopardise the final product. Even a small lapse at this stage can have serious consequences down the line.

Next comes testing—an area that demands both precision and adaptability. Whether it’s a key intermediate, the drug substance or the finished product, each step must undergo stringent testing to detect potential contaminants early. The approach isn’t one-size-fits-all; it needs to be tailored based on the specific molecule and manufacturing process to ensure strong viral safety and microbiological controls throughout

Then there’s viral clearance—perhaps the most complex of the three. While established biologics like recombinant proteins and antibodies often have tried-and-true clearance steps built into production, advanced therapies are a different story. These products are incredibly sensitive, making traditional methods like detergent treatment, low pH or nanofiltration potentially harmful. For cell and gene therapies, this means there’s often no room for error. In such cases, the onus shifts even more heavily onto upstream strategies—sourcing clean raw materials and conducting exhaustive testing—to keep contamination risks at bay.

“I stay deeply connected with our clients to understand their evolving needs and relay those insights to our leadership team. This ensures we’re prioritizing the right innovations— those that genuinely move the needle on both speed and safety”

Modernising Biosafety for Viral Vectors with Next-Gen Tools

As emerging modalities like viral vectors gain traction, their safety demands a more specialised and forward-thinking approach. For therapies involving adenoassociated viruses (AAV), adenoviruses (AV), lentiviruses (LV) and retroviruses (RV), replication-competent virus (RCV) assays are critical to verify the absence of viruses capable of replicating. This step is essential to protect patient safety and maintain therapeutic integrity.

One of the most promising developments in this space is the rise of next-generation sequencing (NGS). This cutting-edge technology is rapidly redefining how viral safety is approached. NGS offers a more comprehensive, sensitive and unbiased method for detecting adventitious viruses, positioning it as a potential replacement for traditional in vitro tests and legacy assays like MAP, HAP and RAP—especially in antibody development.

Looking ahead, NGS may go beyond complementing existing techniques. It has the potential to overtake polymerase chain reaction (PCR)- based methods altogether, becoming the gold standard for viral screening across the biotech industry. As therapeutic platforms become more complex and safety expectations rise, adopting advanced tools like NGS will be critical to keeping pace with innovation without compromising on safety.

Multi-Spike Approach for Greater Efficiency

With growing pressure to bring therapies to market faster, companies are demanding quicker turnaround times for the release of critical intermediates and final drug products. This is where NGS proves invaluable—its speed and sensitivity help cut down traditional testing timelines without compromising safety.

apid stability testing method that delivers faster bioburden and stability assessments compared to conventional techniques. Together, NGS and Celsius are reshaping biosafety testing, offering a smarter, faster and more efficient path to product release. On the viral clearance front, we’ve introduced a multispike strategy to boost speed and cost efficiency.

By allowing clients to spike their materials with Murine Leukemia Virus B (MLVB) and Minute Virus of Mice (MVM) in a single run, we streamline the detection of residual infectivity. This dual-virus approach reduces the volume of material needed, minimises the number of test runs, and significantly lowers overall study costs. For advanced therapies—where production batches are often small and material is precious—this strategy makes a meaningful difference. It’s a smarter, more resource-conscious way to ensure safety while keeping development timelines on track.

Balancing Speed and Safety

Speed and safety are no longer trade-offs in today’s biologics landscape—they’re dual priorities. At Charles River Laboratories, we’re embracing rapid methods like NGS and fast-track stability testing to accelerate drug release while upholding the highest safety standards.

More and more companies are also shifting from quantitative PCR (qPCR) to droplet digital PCR (ddPCR), which requires significantly less material for testing. This is especially valuable when working with limited intermediate or drug product volumes—helping clients conserve resources without slowing timelines.

We’re also looking ahead. AI is opening new possibilities to reduce sample requirements and streamline drug release even further. By integrating AI and digital tools into our workflows, we’re not just speeding up processes—we’re planning smarter, executing more precisely and releasing results faster—all while staying fully aligned with Good Manufacturing Practices (GMP). Quality is the bedrock of our work, and we will never compromise it for speed. But we do recognise that in this industry, speed is essential—and every improvement we make is guided by that understanding.

As a manager, I stay deeply connected with our clients to understand their evolving needs and relay those insights to our leadership team. This ensures we’re prioritizing the right innovations—those that genuinely move the needle on both speed and safety.

At the end of the day, our mission at Charles River is clear—to help clients bring their therapies to market faster, with confidence in the safety and integrity of every batch. It’s a promise that drives our global strategy and one we remain fully dedicated to as we continue pushing the boundaries of biosafety testing.

Faster, Safer, Smarter: The Path Forward in Advanced Therapies

NGS is poised to redefine how we approach drug testing and release. Replacing methods that have been the industry standard for more than 25 years, NGS represents a major leap forward—bringing greater speed, sensitivity and reliability to biosafety testing.

But adopting technologies like NGS isn’t just about keeping up with innovation—it’s about embracing a mindset of continuous improvement. To fully unlock the potential of these tools, we need to remain open to evaluating new approaches while working closely with regulators to ensure they meet, or even exceed, the quality benchmarks set by traditional methods. Innovation must extend across the entire value chain—from manufacturing to testing to product release—always with the goal of delivering safer, more accessible treatments to patients.

My message is simple—keep an open mind. Be willing to explore emerging technologies and think differently about how we bring therapies to market. By doing so, we not only advance science—we give hope to patients waiting for better, safer and more effective treatments, particularly in areas of unmet medical need.