Biosimilar White Papers

41. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

42. 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.

43. Ensuring Strength And Flexibility Of Single-Use Bags In All Applications 3/18/2019

    The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.

44. Accelerate CHO Cell Characterization With The Blazar™ Rodent Panel: A Guide For Adoption 2/24/2021

    The development of the Blazar™ Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.

45. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand 5/30/2019

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

46. Cell Based Potency Assay In Functional Characterization Of Therapeutic mAbs 6/12/2019

    Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be emoloyed.

47. 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.

48. The Role Of CDMOs In Cell And Gene Therapy Process Development 8/5/2020

    This article highlights areas where CDMOs can help companies get started in CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.

49. Virus Safety For Continuous Processing 9/5/2019

    Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

50. Robust By Design: How BD Is Overcoming The Biologics Challenge In Drug Delivery 9/18/2020

    Autoinjectors used with pre-fillable syringes offer multiple benefits, from providing an accurate dosage to reducing the number of needlestick injuries (needles are protected after use). BD-designed autoinjectors can deliver drugs of differing viscosities in a well-integrated robust system.