Biosimilar White Papers

  1. Three Options To Viral Vector Manufacturing Capacity 9/1/2020

    A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.

  2. Ensuring Consistency In The Supply Of Cell Culture Media 12/16/2020

    This paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.

  3. Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics 9/11/2019

    Challenges exist when developing biologic drugs to be efficacious but safe. Novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

  4. End Of End Point Assays: SPR Analytics In Vaccine Design, Development 2/18/2021

    Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.

  5. 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.

  6. User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe 9/17/2020

    Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.

  7. 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.

  8. 8 mm Needle – Improving Subcutaneous Chronic Drug Delivery 7/21/2020

    This paper describes how reducing needle length can improve the risk profile of subcutaneous injections and can make injecting viscous formulations easier and quicker, and highlights BD’s development programme for an innovative shorter needle with ultra-thin walls for prefilled syringes.

  9. CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy 5/31/2019

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

  10. Understanding And Controlling Raw Material Variation In Cell Culture Media 9/5/2019

    An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.