Cell And Gene Articles, App Notes, Case Studies, & White Papers

  1. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

    Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

  2. Pioneering Gene Therapy In Rare Diseases 3/17/2025

    Overcoming barriers to gene therapy development requires continued innovation in manufacturing processes, harmonized regulatory approaches, and outcome-based pricing models.

  3. Highly Sensitive ELISAs In 90 Minutes 9/11/2024

    Traditional ELISA methods are often limited by their relatively low throughput and need for multiple wash steps. Learn about a solution that overcomes these challenges and provides rapid results.

  4. Optimizing Aliquoting For Robust Cell And Gene Therapy Processes 6/3/2024

    Explore the challenges of liquid handling in cell and gene therapy processes as well as innovative solutions to simplify aliquoting in modern bioprocesses.

  5. Examining A Phase 1 COVID-19 Clinical Trial 5/10/2024

    Uncover how we were able to efficiently activate the site and enroll 130 participants within six months, demonstrating our expertise in clinical trial management.

  6. From CLD To CDMO: Demonstrating A Successful Cell Line Technology Transfer 8/5/2024

    Explore critical considerations for biopharmaceutical developers and CDMOs during technology transfer as well as a successful transfer and scale-up of a cell line from a CLD platform to a global CDMO.

  7. Enabling Market Access As CGTs Reach More Patients 5/5/2025

    Bringing potentially curative cell and gene therapies to more patients requires a focused approach to market access. Discover essential insights into payer dynamics, pricing innovations, and treatment evolution.

  8. Streamlining The Importing & Exporting Of Biological Samples 9/1/2024

    Create a seamless and predictable import and export process by working with experienced bioanalytical laboratory partners, understanding what paperwork samples require, and proactive planning.

  9. Simplify CAPA In 7 Steps 9/20/2024

    Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

  10. The Value Of Peptones For Enhancing Biopharmaceutical Productivity 11/18/2024

    Peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.