Biosimilar White Papers

  1. Explore Protein Function Using Surface Plasmon Resonance (SPR) 5/20/2021

    We’ve collected a few examples of how an academic research group used Biacore™ X100 SPR system in their research to investigate protein-RNA, protein-protein interactions, and how researchers have used SPR to measure antibody specificity. Download the white paper A year of interaction with Biacore™ X100.

  2. Taking Charge Of Your Stability Program 10/5/2022

    Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

  3. Key Stages In mRNA-Based Therapeutic Development 9/13/2022

    Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.

  4. Secure The Cell Therapy Supply Chain From Bench To Bedside 10/4/2021

    While current approaches can manage the existing volume of cell therapy shipments, scaling these treatments up and out will increase pressure on cryogenic logistics networks. 

  5. Regulatory Considerations For Alternative Microbial Methods 2/28/2022

    This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.

  6. Process Development Considerations For RNA-LNP Therapeutics 9/13/2022

    Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).

  7. Orthogonal Methods To Understand And Define CQAs Of AAV Therapies 2/24/2023

    An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

  8. A Risk-Based Approach To The Development Of An Injectable Combination Product 3/14/2023

    Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

  9. The Dynamic Regulatory Environment Of Drug-Device Combination Products 11/29/2022

    Examine the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time to market.

  10. The Science Of Cell Therapy Thawing 4/5/2021

    A summary of the science of thawing following conventional slow freezing methods, the physical and biological implications of key metrics and components, and key studies from scientific literature.