Future-Proofing Your Cell and Gene Therapy

Bringing a therapy to market comes with challenges: tight timelines, evolving regulations, and the need for manufacturing solutions that scale without compromise. Biotech developers, pharma companies, research organizations, and patient foundations must navigate these pressures while ensuring product quality and patient safety. This eBook will go beyond just talking about how to streamline manufacturing but also provide in-depth insights into topics that aren’t always covered to the same degree but are just as important to ensuring clinical and commercial success—solid analytical, testing, and regulatory strategies.

One way to ensure that your critical quality attributes are ready for process development and, eventually, tech transfer to GMP manufacturing, is to invest early in analytical development, testing, and regulatory preparedness. By taking steps to characterize your assays and controls from the beginning, you can save time and money downstream when your drug product is already compliant and ready for IND submission. While assays and controls may need further development work as more clinical data is available, a phase-appropriate approach is better than the delays and setbacks from inconsistent or incomplete analytics that may cause significant re-work.

Fortunately for drug developers, an experienced CDMO like Charles River can develop and refine methods that meet critical quality attributes and ensure they are reproducible and able to translate to clinical and commercial success. Additionally, a CDMO can provide the tools and technology needed to more quickly test and scale through platforms, whether that’s plasmid DNA and viral vector production platforms to off-the-shelf solutions for cell therapy manufacturing to Next Generation Sequencing (NGS), a solution that provides broader and more efficient detection capabilities as compared to legacy systems. Through automated, closed-system processing and a platform approach, technology integration can improve reproducibility and accelerate timelines while reducing variability and contamination risks.

With over 20 years of experience, global Centers of Excellence, and 100% in-house testing, Charles River helps clients streamline development and gain a clear path to commercialization. Because every moment matters, from concept to cure.