Question 1

What is a cell and gene therapy orchestration platform?

Accepted Answer

A cell and gene therapy orchestration platform manages the complex, time-sensitive workflows involved in delivering advanced therapies from manufacturer to patient. It coordinates patient identification and eligibility screening, vein-to-vein scheduling, chain of identity and chain of custody tracking, treatment centre onboarding, and post-treatment monitoring — all on a single system that connects manufacturers, treatment centres, logistics partners, and patient support teams.

Question 2

How is advanced therapy supply chain management different from traditional pharma?

Accepted Answer

Advanced therapy supply chains are uniquely patient-specific and time-critical. Unlike traditional pharma, each unit is manufactured for a single patient, meaning scheduling, labelling, and logistics must maintain continuous chain of identity. The product is often autologous (made from the patient's own cells) and has short shelf lives, requiring precise coordination across apheresis centres, manufacturing sites, cryogenic logistics, and treatment facilities.

Question 3

What is chain of identity (CoI) in cell therapy?

Accepted Answer

Chain of identity (CoI) is the documentation and tracking process that confirms a cell therapy product originated from and will be administered to the correct patient throughout the entire manufacturing and logistics journey. Regulatory authorities including the FDA and EMA require robust CoI controls. Digital orchestration platforms maintain CoI by linking patient identity to each sample, manufacturing batch, logistics shipment, and administration event with full audit trail.

Question 4

What regulatory requirements apply to advanced therapy manufacturing?

Accepted Answer

Advanced therapies are regulated under specific frameworks: in the EU under the ATMP Regulation (1394/2007), in the US under 21 CFR Part 211 and specific FDA guidance for cell and gene therapy products, and under ICH Q10 for pharmaceutical quality systems. GMP requirements apply to manufacturing, with additional requirements for cryopreservation, chain of custody documentation, and patient-specific labelling. Clinical trial phases must comply with ICH E6 GCP guidelines.

Question 5

How do treatment centres get onboarded for advanced therapies?

Accepted Answer

Treatment centre onboarding for advanced therapies involves qualification assessment, staff training certification, systems integration with the manufacturer's orchestration platform, and regulatory accreditation (such as FACT or JACIE certification). Digital onboarding platforms streamline this by providing guided qualification workflows, document exchange portals, training management, and real-time scheduling integration — reducing onboarding timelines from months to weeks.

Question 6

What post-treatment monitoring is required for advanced therapies?

Accepted Answer

Advanced therapies require long-term post-treatment monitoring due to their novel mechanisms and potential for delayed adverse events. Regulatory agencies require long-term follow-up (LTFU) data collection for up to 15 years for gene therapies. Monitoring platforms track patient-reported outcomes, serious adverse events (including cytokine release syndrome and immune effector cell-associated neurotoxicity), re-treatment eligibility, and real-world evidence collection for post-market commitments.

Every handoff orchestrated. Every therapy delivered.

A single missed handoff can cost a patient their therapy.

One missed handoff. One lost therapy.

From diagnosis to treatment centre — the first critical window

Orchestrated end-to-end. Owned by your team over time.

Every stakeholder. Every handoff. Every constraint.

Proven in advanced therapy delivery.

A global pharma company launching a specialty therapy across multiple treatment centres needed to eliminate handoff failures that were delaying patient access by an average of 3 weeks.

Everything we can deploy for Advanced Therapies.

Cell & Gene Therapy Orchestration

Apheresis & Collection Management

Cold Chain & Logistics Tracking

REMS Compliance Platform

Treatment Center Coordination

Post-Treatment Monitoring

Frequently asked questions