Biosimilar White Papers

31. Increasing Productivity In Hydrophobic Interaction Chromatography 2/27/2020

    In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

32. Cell Growth Performance In Single-Use Bags 3/15/2019

    Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trends are towards higher cell densities and protein titers.

33. Assurance Of Quality Supply For Single-Use Pre-designed Solutions 3/18/2019

    Read how resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.

34. Early Product Characterization De-Risks Biologics Development 6/12/2019

    The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to making informed decisions, accelerating development, and reducing risk.

35. Using In-Line Sensors For Real-Time Control 9/28/2020

    There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.

36. Not Everyone Loves Surprises: Know Your ADC’s Critical Quality Attributes 2/21/2020

    Combatting the challenges of developing and manufacturing ADCs requires robust product characterization throughout all phases of development.

37. QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1 10/21/2020

    Quality Risk Management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its lifecycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.

38. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

    The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

39. Tumor-Infiltrating Lymphocytes: What, Why, And How 7/1/2020

    As we explore immune mechanisms using technology, we find better ways to fight disease. Here, we focus on targeted, highly personalized cancer therapies called tumor-infiltrating lymphocytes.

40. Considerations for improving outcome in biopharmaceutical process development 8/12/2020

    In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.