Cell and gene therapy developers face a continuously evolving regulatory landscape and intense scrutiny over product safety. As the number of therapeutics advancing toward commercialization rapidly increases, regulatory bodies are increasing their emphasis on safety, making it essential to enact proactive strategies to meet or exceed regulator expectations. The use of antibiotics in biotherapeutic manufacturing poses a double-edged risk: antimicrobial resistance (AMR) genes may be transferred to patients, exacerbating a growing public health issue, and residual traces of antibiotics may cause serious allergic or immunogenic reactions.
Raw material plasmid production solutions can offer an efficacious solution to limit end-to-end antibiotic contamination risks. Discover the Power of Small with Nanoplasmid™, a solution to eliminate antibiotic-resistant plasmids in cell & gene therapies. Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate your therapy to market.