Biosimilar Development solution center

  1. After Decades Of Biomanufacturing Workforce Development, What’s Next? 2/1/2023

    We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.

  2. Establishing A Robust Workflow To Identify High-Performing Clones 1/13/2023

    Cell line development is a complex, labor intensive, and multistep process. Learn about a platform and host cell line that minimize the risk and timeline to develop high-performing clones.

  3. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

    The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

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

    Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

  5. 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.

  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. 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.

  8. Natural Killer Cells Manufacturing 7/22/2022

    Follow the feasibility of xeno‑free NK cell expansion, closure of key unit operations, and how future work could focus on fine‑tuning each step to generate a robust, scalable process.

  9. 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.

  10. Explore Protein Interactions Beyond Affinity To Boost Your Academic Research 7/20/2022

    Explore how you can simplify research on protein-protein interactions using our SPR systems.