Cell and Gene Outsourcing

  1. Practical Applications For Controlled And Safe Nucleic Acid Delivery 7/21/2025

    Explore the science behind LNP formulation development, from ionizable lipids to scalable manufacturing through case studies, screening strategies, and flexible approaches for advancing next-generation therapeutics.

  2. Meet The Experts: Part 1 - Process Analytical Technology (PAT) 5/1/2023

    Watch part 1 of this 4-part interview series to learn about process analytical technology (PAT) from expert Stacy Shollenberger.

  3. How To Bring Your LNP Formulation To Clinical/Commercial Manufacturing

    Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.

  4. The ICH Q5A Revision, Its New Scope And Guidance 12/1/2022

    Learn about the ICH Q5A revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin that was recently published for public comment.

  5. Cell & Gene Therapy Development: Characterization Of Cellular Starting Material 6/21/2024

    Watch to gain valuable insights into the characterization of cellular source material for the development and manufacture of cell and gene therapy-based products.

  6. Explore What's Next: Product Characterization 7/17/2019

    Newer, high-resolution analytical techniques help answer questions regarding product heterogeneity and drug functions, and help assess for product-related aggregates and impurities.

  7. Evaluating Viral Clearance For Continuous Processes 10/18/2020

    Is viral clearance a hurdle to implementing continuous processing? Here we share virus spiking alternatives that may pave the way for evaluating viral clearance by chromatography steps.

  8. CRISPR Genome Editing Solutions From Discovery To Clinic

    Examine how a partnership leveraging expertise in production for high-quality CRISPR gRNAs as well as cGMP manufacturing is supporting the clinical translation of CRISPR genome editing technologies.

  9. Biotherapy Characterization: Binding Assays 7/17/2019

    MilliporeSigma Senior Scientist Helen Hsu, Ph.D. describes how, with our custom binding assays, and supported with our comprehensive off-the-shelf Fc gamma receptor binding assays, we can help you optimize your mAb production, from clone development through upstream and downstream processes.

  10. Quality Agreements: Defining Governance In CDMO Partnerships 5/15/2024

    Quality agreements serve a critical role within a CDMO-Sponsor partnership. Review the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation.