Biosimilar White Papers

31. 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.

32. Business Continuity Program: Maintain Operations During Crises 5/5/2020

    Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

33. Mechanistic Modeling Of Chromatography To Speed Up Process Development 3/2/2020

    Catch up on the current opportunities and challenges for using mechanistic modeling to simulate and predict chromatographic behavior and experiments in silico. 

34. 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.

35. Addressing The Evolving Needs Of Variable Drug Delivery Regimens 9/14/2020

    Pharmaceutical companies now have a wearable solution designed to enable new delivery formats in alternate settings and for customization to support adjustments to existing formulations and variations in treatment regimens.

36. Identifying Enhanced Needle Solutions And Integrated System Solutions To Serve The Chronic Disease Market 7/17/2020

    Needle innovations, including shorter needles with ultra-thin wall technology for prefilled syringes, support the delivery of drugs with greater volumes and viscosities, enhancing end-user experience.

37. Cell Therapy Scale-Up Strategies For Commercial Success 9/30/2020

    This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.

38. 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.

39. 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.

40. 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.