White Papers

  1. CMC Strategies For The Development Of A Bispecific Antibody Platform for Cancer Immunotherapy

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

  2. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand

    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.

  3. Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

    This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

  4. The Importance Of Data Analysis In Solid-State Characterization

    The secret to performing a thorough solid-state characterization involves integrating all data that may be generated across various instruments at different laboratories and properly interpreting that data.

  5. Lyophilization Of Highly Potent Drugs: Facility and Equipment Design Elements

    Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.

  6. 5 Step Strategy To Accelerate Biologics Manufacturing And Ensure Robust Scale-Up Process

    By establishing a platform approach to process characterization, which has supported the successful approval of several marketed biologics, AbbVie scientists ensure the entire process is robust, right first time, and results in a highly consistent product to facilitate efficient BLA filing. AbbVie’s five-step process below offers a thorough understanding of the biologic and process control strategies to help accelerate time to a robust and reliable commercial scale process.

  7. Viral Clearance: The Basics On How To Conduct Effective Studies

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  8. Guidelines To Bring Your Biologic To Market: Are You Prepared?

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.

  9. Advances In Temperature Calibration Procedures

    Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.

  10. Understanding The Importance Of Punch Length And Cup Depth

    This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.