We are your trusted and experienced global partner for large-scale, commercial manufacturing of nucleic acids
Our innovative technology and quality processes ensure that we deliver exceptional reproducibility and on-time material. Our dedicated team of expert chemists, technical operation leaders, and project managers will guide you through a seamless process wherever you are in your commercial program. Our steadfast commitment to sustainable manufacturing and continuous improvement makes the transition to BioSpring a clear choice.
BioSpring's commitment to a one-source approach means that we support the entire drug development lifecycle, seamlessly integrating services to support early preclinical work through commercial manufacturing of nucleic acids. Our manufacturing facilities include dedicated ISO-certified cleanrooms for commercial manufacturing accommodating hundreds of kilograms of annual manufacturing capacity. Our robust capacity allows for seamless and flexible onboarding of your commercial program. Currently, we are actively manufacturing commercial batches for market supply. Our state-of-the-art facilities are equipped with advanced technologies to ensure precision and efficiency in every stage of production, meeting stringent regulatory standards. BioSpring’s facilities are FDA-inspected for both commercial manufacturing and QC, and we are GMP-certified by German authorities. Additionally, we are officially registered as an API manufacturer with the FDA, EMA, and PMDA.Commercial Manufacturing
Supporting your therapy's market authorization:
Process validation ensures that your manufacturing process produces quality and consistent results, ensuring product efficacy and safety. BioSpring has been validating nucleic acid drug substance manufacturing processes since 2016. Leveraging our expertise, we successfully completed numerous validation campaigns, handling multiple hundred kilogram batch sizes. Our efforts have supported top-tier clients within the nucleic acid industry with identifying and mitigating potential risks arising during the manufacturing process and building a more robust manufacturing process to reduce costly errors or batch failures. Designed with patient safety in mind and regulatory compliance, our process validation services will ensure that every step of the manufacturing process is meticulously evaluated and documented.Process validation services
