The Operational Intelligence Archive of Cell & Gene Therapy.

BioBridge Global COO Adrienne Mendoza details how mobile leukapheresis and true electronic batch records bypass regional geographic bottlenecks, untangle the reimbursement friction of upstream cell collection, and eliminate fatal documentation delays across the vein-to-vein supply chain.

Cell therapy pioneer and entrepreneur Claudia Zylberberg argues that industry expansion is constrained by clinical adoption and operational friction rather than a lack of tool innovation, detailing how solving the "hospital equation," breaking down siloed EHR and manufacturing data fragmentation, and creating unified digital infrastructure will unlock decentralized patient care.

Cell therapy executive and investor Lee Buckler breaks down why commercial CAR-T adoption has plateaued at 20%, detailing how resolving hospital contracting bottlenecks, adapting FACT accreditation, and mobilizing existing regional apheresis and cryopreservation networks can unlock outpatient delivery for the 80% of patients treated in community settings.

Former FDA investigators DeVaughn Edwards and Elvia Cervantes dissect the critical inspection blind spots across GMP and GCP workflows, detailing why siloed quality teams and lax vendor oversight trigger 483 citations—and why sponsors can never outsource regulatory responsibility.

Dr. Eric Tran (Providence Health), patient advocate Melinda Bachini (Cholangiocarcinoma Foundation), and healthcare investor Paul Chun break down the clinical, financial, and logistical bottlenecks facing TIL therapies—evaluating peripheral blood harvesting to bypass surgical resections, managing severe preconditioning toxicities, and reforming trial design to treat solid tumor patients before systemic immune exhaustion.

Dr. Patrick Hanley of Children’s National details the operational friction hospital cell labs face when integrating commercial cell therapies, breaking down portal fatigue, the severe logistical burden of unpredictable vein-to-vein timelines, and the ethical catch-22 of securing pediatric starting material for process validation.

Former Pfizer Senior Global Medical Benefit-Risk Lead Dr. Angeliki Kotsianti explains why drug shortages and supply chain vulnerabilities are fundamentally clinical crises rather than warehouse glitches, detailing why upstream governance and medical judgment must guide non-conforming release decisions before supply failures hit the bedside.

Dr. Patrick Hanley of Children’s National details the operational friction hospital cell labs face when integrating commercial cell therapies, breaking down portal fatigue, the severe logistical burden of unpredictable vein-to-vein timelines, and the ethical catch-22 of securing pediatric starting material for process validation.

CCRM Australia CEO Silvio Tiziani analyzes the cell and gene therapy manufacturability gap, detailing how ignoring GMP requirements early triggers catastrophic tech transfer rework back to the bench, and why modular "widget" platforms are critical to slashing systemic production costs.

Forge Biologics CTO David Dismuke breaks down the critical operational pitfalls in AAV gene therapy development, detailing why early investment into empty-to-full capsid analytics, robust potency assays, and disciplined two-sided tech transfer is essential to prevent costly returns to the bench.

Pioneering TIL therapy survivor and patient advocate Melinda Bachini exposes the unvarnished operational and socioeconomic barriers to cell therapy access—breaking down the heavy travel and caregiver burdens facing rural families, the clinical paradox of forcing patients to progress on toxic standard-of-care therapies before trial eligibility, and the urgent need for early tumor tissue banking to outpace disease recurrence.