Outsourced Pharma App Notes & Case Studies

31. Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies 2/9/2024

    In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.

32. Overcoming Supply Chain Roadblocks To Ensure Reliable Complex OSD Delivery 2/26/2024

    Ensuring critical oral solid dosage (OSD) therapeutics reach patients successfully relies on the ability of developers and manufacturers to navigate the inherent issues surrounding their increasing complexity.

33. Developing A HIC Polishing Step For The Removal Of mAb Aggregates 9/28/2023

    Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.

34. 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.

35. Review Of Applications And Processes In Fixed-Bed Bioreactors 5/6/2024

    Gain insights and guidelines for developing new processes in this review evaluating publications on the applications of single-use, scalable fixed-bed bioreactors for adherent cell culture processes.

36. Modelling TPDs Utilizing Computational And Medicinal Chemistry Approaches 5/16/2025

    Through a carefully executed strategy, see how we identified novel degrader molecules with the right physicochemical properties to achieve robust degradation of the target Protein of Interest (POI).

37. Integrating Phase-Appropriate Quality Standards 12/9/2024

    Incorporating phase-specific quality standards ensures GMP compliance throughout biopharmaceutical development. Collaborating with an experienced CDMO addresses late-stage quality needs and efficiently manages accelerated product development timelines.

38. Protein L Affinity Resin Is Ready To Move To Manufacturing 7/12/2023

    Discover a protein L affinity chromatography resin that is well suited for use in biomanufacturing and offers increased binding capacities compared to other resins.

39. Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest 10/20/2023

    Learn how MilliporeSigma helped a customer drastically reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

40. Analytical Method Release And Stability Platform For RNA Drug Substance 3/14/2025

    We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.