Biosimilar White Papers

  1. Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy 7/21/2020

    Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

  2. Getting Your Investigational Drug Regulatory Ready 12/1/2020

    Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

  3. Critical Considerations About The Future Of Global Cell Culture Bioprocessing 4/2/2019

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

  4. How Buffer pH And NaCl Affect Size Exclusion Chromatography 4/22/2020

    Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

  5. Single-Use Platforms Accelerate Viral Vaccine Development, Manufacturing 10/31/2019

    Analysts predict the vaccine market could grow at as much as 10.3 percent through 2024 (CAGR). Single-use platforms might be pivotal to meeting that demand.

  6. 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.

  7. 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.

  8. 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. 

  9. Strategies To Address The Viral Vector Manufacturing Shortage 3/5/2020

    Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.

  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.