Improving mAbs Impurity Clearance Through Use of Selective Additives (Feb 2023)
Developing more effective chromatography resins for mAbs downstream processing is important ⏤ but it's not the only way to improve impurity clearance. In this study of the use of additives to enhance resin performance, two mAbs chromatography resins were examined. Both were used for a capture step, and additives were screened to reduce the nonspecific binding of impurities. The goal of the study was to optimize chromatography steps and thus increase the capacity and removal of impurities.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Your Ultimate Guide for CMC Testing Support for Gene and Cell Therapy
November 21st 2024Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, and quality of advanced therapies, supporting your journey from product development through regulatory approval.
Ensuring Quality from the Start: Raw Materials Testing Support
November 21st 2024Raw Materials are the foundation of every biopharma product. Our ultimate guide highlights how our testing support can help you establish purity, identity, and quality standards, ensuring a smooth manufacturing process and adherence to regulatory requirements.
Ensure the Safety of Allogeneic Therapies with Advanced qPCR Testing
November 21st 2024Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline. Protect your products – and your patients- with industry-leading sensitivity and specificity.
Risk-Based Development Supporting Process Qualification for Spray-Dried Dispersion
November 13th 2024Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process design and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for small-molecule drug products. Watch this video to learn more about:
