INSIGHTS ON CELL & GENE THERAPY LOGISTICS

• How IntegriCell™ Services In Belgium Ensure Cell Viability, Supply Chain Integrity

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

• How BioServices Centers In France Enable Efficiency And Scalability

  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.

• PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand

  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.

• ICH Revises Q1 Guideline, Advancing Stability Testing Standards

  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.

• Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers

  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. 

• Why You Need A Raw Material Control Strategy

  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.

• Comparing Manual Vs. Automated Processing And Thawing Systems

  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.

• Bridging The Gap Between Lab Development And GMP Manufacturing

  In this first segment of 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 focus on best practices for translating laboratory development processes into CGMP manufacturing settings.

• Pharmaceutical Sovereignty: The Resilience We Cannot Outsource

  Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration. 

• From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials

  Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.