Cell and Gene Logistics

1. 8 Ways To Drive Resilience In Oncology Drug Supply Chains 5/2/2025

   From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

2. How IntegriCell™ Services In Belgium Ensure Cell Viability, Supply Chain Integrity 4/28/2025

   he effectiveness of cell-based therapies hinges on preserving cell viability, stability, and consistency. However, inconsistencies in cryopreservation methods have undermined therapeutic success.

3. How BioServices Centers In France Enable Efficiency And Scalability 4/28/2025

   To support the growing demands of the ATMP industry, it's essential to leverage integrated biostorage, sample management, and regulatory solutions, and we are committed to enhancing these capabilities.

4. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

   Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

5. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

6. Deep Interpretation Of GMP Product Quality 4/23/2025

   Explore the critical aspects of GMP-grade raw materials in cell and gene therapy manufacturing, including contamination control, aseptic strategies, quality systems, supply chain security, and regulatory compliance.

7. Raw Materials Considerations When Manufacturing CGTs And Other Biologics 4/23/2025

   Discover key considerations for qualifying GMP raw materials in cell and gene therapy manufacturing, emphasizing quality control, supplier selection, and regulatory compliance to ensure therapeutic safety and efficacy.

8. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

   The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

9. Why You Need A Raw Material Control Strategy 4/17/2025

   You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.

10. Comparing Manual Vs. Automated Processing And Thawing Systems 4/15/2025

    In this segment of our Cell & Gene Live, Optimizing Storage Solutions for iPSCs, expert panelists Pratik Jaluria, Ph.D., SVP Technical Development Strategy at BlueRock Therapeutics, Bruno Marques, Ph.D. VP, Process and Product Development at Century Therapeutics, and Kate Rochlin, Ph.D., COO at IN8bio share that a well-constructed manual operation can be matched by an automated system, but there is a higher capital expenditure.