Biosimilar App Notes & Case Studies

31. Optimization And Scale-Up Of A Plasmid DNA Production Process 9/30/2025

    Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.

32. Selecting A Platform Filter For High Concentration mAbs 4/9/2025

    Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.

33. 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.

34. Enabling Accelerated Raman Model Calibration For Real-Time Monitoring 6/14/2024

    Raman spectroscopy is a key component of a PAT strategy. Evaluate an innovative workflow designed to streamline the integration of an in-line Raman analyzer for bioreactor applications.

35. Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool 3/24/2025

    Transferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.

36. Implementation Of Multi-Column Chromatography Systems 4/4/2025

    Discover how a multi-column chromatography system enhances resin utility and enables continuous bioprocessing with minimal surge tankage for agile multi-product facilities.

37. Cell Culture Media Filtration: Evaluating Cell Culture Performance 10/23/2025

    Cell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.

38. Virus Retention Performance Under Diverse Processing Conditions 11/14/2025

    Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.

39. Balancing Protein A Resin Cost, Performance, And Productivity 7/31/2025

    Optimizing input parameters like DBC, flow rate, and resin durability is key to boosting productivity in downstream bioprocessing. Discover how to tailor resin choices to meet your specific process requirements.

40. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.