Cell and Gene Regulatory

  1. Compliant Storage For Chemicals, Process Liquids, And Buffers 11/5/2025

    Maintain material quality and integrity with storage facilities compliant with ISO 9001, cGMP, and GDP standards. Features include real-time temperature control and HAZ-class segregation.

  2. Inventory Management Support For Chemicals, Process Liquids, And Buffers 11/5/2025

    Effective inventory management ensures the quality and traceability of raw materials, supports regulatory compliance, and enables operational savings. Learn how to secure your supply chain and reduce stockouts.

  3. A CDMO Perspective: Bioprocess Automation And Data Management 11/5/2025

    Watch this video to understand data management and process automation challenges across single-use bioprocessing applications from a CDMO leader, Paul Jorjorian, VP and GM of Pharma Services at Thermo Fisher Scientific.

  4. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

    Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.

  5. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

  6. Highly Sensitive ddPCR Method For Detection Of Replication-Competent LVVs 10/30/2025

    A highly sensitive ddPCR assay targeting the VSV-g sequence allows for absolute quantitation and robust monitoring without product-specific qualification.

  7. The Power Of Next Gen Sequencing, Bioinformatics To Propel Viral Safety 10/30/2025

    NGS is a powerful, rapid method for comprehensive viral detection in biopharmaceuticals. Regulatory acceptance for non-targeted NGS is gaining momentum as an alternative to traditional testing.

  8. Minimizing Volume Requirements, Turnaround Time For Compendial Testing 10/30/2025

    Effectively applying compendial testing to cell and gene therapy products requires strategic test ordering and specialized micro-equipment to manage limited volume and accelerate turnaround time.

  9. Maintaining Compliance In Gene Therapy Trials For Neurological Conditions 10/29/2025

    To identify efficacious treatments for neurological conditions, drug sponsors must design ethical clinical trials that protect participants and caregivers while ensuring compliance with regulators.

  10. Developing Your Risk-Based Approach To Single-Use System Integrity 10/29/2025

    Explore how a holistic approach to single-use system integrity can strengthen contamination control, improve operational efficiency, and meet evolving regulatory expectations in manufacturing.