Biosimilar White Papers

1. Outstanding Sensitivity For Confident SPR Interaction Analysis 7/20/2022

   Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.

2. 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.

3. 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.

4. 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.

5. 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. 

6. 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.

7. Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster 3/24/2023

   Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.

8. 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).

9. 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.

10. Optimizing Lipid Formulations For Targeted RNA-LNP Applications 9/13/2022

    Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.