Outsourced Pharma App Notes & Case Studies

31. Extractables In Single-Use Systems Used In ADC Manufacturing 9/23/2024

    To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

32. Boosting Cell Culture Yields With Intensified Fed Batch Processing 8/12/2024

    Traditional fed-batch cell culture processes face limitations due to inherent cell line restrictions and accumulation of byproducts during the process, necessitating new approaches that improve cell performance.

33. Developing A Large-Scale Tangential Flow Filtration Process 5/13/2024

    Discover a process that can be modified to fit your downstream process and serves as a complete solution for concentration and diafiltration.

34. Packing MabSelect™ And MabSelect SuRe™ Resins Using Verified Methods 12/6/2024

    Proper packing of MabSelect resins is crucial for efficient chromatography. Verified methods ensure stability, optimal flow, and reproducibility across scales using automated tools.

35. Integrated Strategies for Achieving Regulatory Milestones Faster 10/12/2023

    Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

36. Cell-Free Modeling Approach For Efficient Cell Culture Monitoring 6/14/2024

    Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.

37. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

    It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

38. Getting CMC Right For Emerging Technologies 12/20/2023

    Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

39. CDMO Accelerates Contract Manufacturing With Electronic Batch Records 9/18/2024

    A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

40. mRNA Purification Using Anion Exchange Chromatography At Ambient Temperature 12/11/2024

    Explore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.