Cell and Gene Regulatory

  1. Rescuing A Global Program For NDA Success 8/12/2025

    Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

  2. Recombinant Trypsin Frequently Asked Questions 8/11/2025

    Learn more about the key features of a high-quality recombinant trypsin and how it can benefit your bioprocess with insightful answers to these common questions.

  3. Unfiltered: The Great PFAS Debate 8/7/2025

    Explore the global concern over persistent “forever chemicals” linked to health and environmental risks, as well as learn about regulatory debates, global restrictions, and why urgent action is needed.

  4. Streamline Production With A Final Filling Single-Use Set 8/7/2025

    Streamline your production with a Final Filling Single-Use Set that installs in under 10 minutes to eliminate cleaning and sterilization while ensuring Annex 1 compliance and full customization.

  5. Best Practices For Regulatory Excellence In Clinical Research 8/7/2025

    Observe how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.

  6. FDA Fridays: Advancing Communication and Consistency in CGT Regulation with Kaye Spratt 8/7/2025

    This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kaye Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting.

  7. Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines 8/6/2025

    As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

  8. How Compliance-Driven CDMOs Win Sponsor Contracts 8/6/2025

    Discover how evolving global regulations are reshaping CDMO strategy. and how digital infrastructure helps manufacturers stay audit-ready, build sponsor trust, and turn compliance into an advantage.

  9. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  10. PHCbi LabSVIFT® IoT Lab Management Solution 8/5/2025

    PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model