Cell and Gene Regulatory

  1. Getting To A First Product Approval With Celcuity's Brian Sullivan 8/13/2026

    On this week's episode of the Business of Biotech, Brian Sullivan, CEO at Celcuity, talks about winning the company's first FDA approval for Revtorpyk, a kinase inhibitor for breast cancer patients, and why targeting an “untreated disease mechanism” can beat chasing a single mutation.

  2. Efficient Clone Screening With Increased Process Control And Integrated Cell Health And Titer Measurements With The Cydem VT Automated Clone Screening System 8/12/2026

    Automated screening of antibody-producing clones provides real-time cell health and titer data, helping developers identify top-performing candidates earlier and with confidence.

  3. GLP-1 Peptides Around The World 8/12/2026

    Explore how evolving regulations, supply constraints, and reimbursement models shape GLP-1 drug development across the U.S., Europe, and Asia.

  4. Partnering For Success: Microbiological Testing In Contract Laboratories 8/12/2026

    Outsourcing microbiological testing goes beyond method selection. Learn how early lab engagement, redundancy planning, and regulatory alignment protect your release timelines and compliance.

  5. Why A Strong CMC Roadmap Is Essential For Cell Therapy Program Success 8/8/2026

    A structured regulatory roadmap and early management of manufacturing, materials, and assay testing help reduce risk and prevent costly delays in cell therapy development.

  6. How To Build A Cell Therapy CMC Roadmap 8/8/2026

    A structured, phase-appropriate regulatory roadmap helps cell therapy developers reduce risk, streamline manufacturing and testing, and avoid costly clinical delays.

  7. Reducing The Time And Cost Of Robust Analytical Method Development 8/8/2026

    Design-of-experiment methodology accelerates cell therapy assay development, reducing costs and timelines while improving assay robustness, regulatory readiness, and data-driven decision-making.

  8. Life Cycle Assessment (LCA): Empowering Sustainable Decisions 8/7/2026

    Learn how Life Cycle Assessment converts environmental data into practical insights, helping improve product development, sustainability strategies, and decision-making.

  9. Next Generation CHO Host To Boost Your Yield 8/7/2026

    Advance cell line development with a stable, high-producing CHO host supporting predictable growth, efficient clone selection, and scalable fed-batch and perfusion processes.

  10. Improving Bioprocessing Outcomes With The CHOZN® Elite Host Cell Line 8/7/2026

    Accelerate cell line development with a host engineered for high expression, streamlined clone selection, flexible gene integration, and scalable industrial performance.