HYDERABAD, India — Reefer Express, a cold chain logistics company serving India's pharmaceutical and healthcare sectors, today announced a dedicated service line for cell and gene therapy logistics in India, built for products where a few hours outside range can mean a lost treatment.

The new service brings together pre-planned routing, validated packaging, in-load temperature monitoring and documented chain of custody under one accountable provider. It is designed for developers, contract manufacturers and clinical sites that move patient-specific or high-value biologic material and cannot afford gaps in control between pickup and delivery.

Why Cell and Gene Therapy Shipments Need a Different Approach

Advanced therapies are not handled like standard pharmaceuticals. A conventional drug is made in large batches, stored in a warehouse and replaced from stock if a carton is damaged. Many cell and gene therapies work differently. Autologous products are made from a single patient's own cells, which means the starting material and the finished dose each travel once, and there is no spare to send if something goes wrong.

Shelf life is another pressure point. Some products are infused within hours or days of manufacture, so a delayed flight, a customs hold or a stalled vehicle can make the entire batch unusable. Temperature requirements also vary widely. Fresh cell material is often moved chilled, while cryopreserved products may need ultra-low or vapour-phase liquid nitrogen conditions. Each band calls for a different shipper, a different monitoring method and a different handling routine.

Reefer Express said that with these products the shipment is the therapy, so its protocols are built around speed, traceability and a clear owner at every handover.

What the Dedicated Service Includes
Pre-planned routing with backup options

Every programme begins with a route plan that treats delay as a risk to be managed in advance. The team maps the primary path, identifies alternative vehicles and routes, and agrees decision points with the shipper before the first movement. If a road closure, weather event or equipment fault affects the journey, the backup plan is already documented and does not have to be invented under pressure.

Validated packaging matched to the temperature band

Packaging is selected for the product, the route and the season, not applied as a generic solution. Reefer Express offers both passive and active systems through its packaging and distribution service, so the container can be matched to chilled, frozen or ultra-low requirements. Qualification data showing how long a shipper holds range under summer and winter conditions supports each choice, and the pack-out sequence is documented so it is repeated exactly each time.

In-load data logger on every consignment

A sensor on the outside of a box reports the condition of the box, not the product. Each consignment therefore carries a data logger placed inside the load, close to the therapy itself. The logger records at fixed intervals throughout transit, and the data is reviewed at delivery as well as in real time during the journey. Vehicle tracking adds location visibility, so the shipper can see where a shipment is and what condition it is in at the same moment.

Documented chain of custody from pickup to delivery

Every handover is recorded with a time, a location and a named person. This matters for regulators, for sponsors and for clinicians who need to confirm that the product they are about to administer was handled correctly. The custody record travels with the temperature report, so one set of documents tells the complete story of the shipment.

A written escalation path

Alerts only help if someone acts on them. Reefer Express has defined who is contacted, in what order and within what time if a reading drifts or a delay occurs. The shipper knows the escalation path before the first shipment, and the same path applies to every movement. This procedure builds on the company's existing excursion protocol, which sets out notification timelines, decision steps and quarantine procedures.

Reports Shippers Can Rely On

Each movement ends with a temperature report and a custody record. These documents are produced as standard practice, not on request, so quality teams and sponsors can review them without chasing the carrier. The reports are structured to support internal audits, regulatory inspections and investigations if an excursion occurs.

For organisations that follow international distribution standards, the documentation approach is aligned with the principles set out in the World Health Organization guidance on Good Distribution Practices and with the oversight framework of India's Central Drugs Standard Control Organisation. Where products move by air, shippers can also refer to the IATA CEIV Pharma programme as a benchmark for pharmaceutical handling.

Who the Service Is For

Reefer Express supports three groups in the advanced therapy ecosystem.

Developers and sponsors running clinical programmes need to move starting material, investigational products and samples between sites without compromising trial integrity. A single lost shipment can delay a study and cost patients their place in it.

Contract manufacturers and development organisations need dependable lanes between collection centres, manufacturing facilities and treatment sites. Consistent processes help them meet turnaround commitments to their own customers.

Clinical sites and hospitals need confidence that what arrives at the bedside has been kept within specification. Clear documentation and a named point of contact reduce the pressure on clinical and pharmacy teams.

Built on an Existing Cold Chain Foundation

The new service sits on top of the company's established temperature-controlled operations. Reefer Express is a Hyderabad-based provider with 12 warehouses, more than 130,000 pallets of storage capacity, a fleet of 50-plus vehicles and coverage across 100-plus cities in India. Its core offering covers cold chain logistics solutions, temperature-controlled storage, refrigerated road transport and healthcare logistics.

That foundation matters because advanced therapy shipments rarely move in isolation. They depend on cold storage at either end, reliable vehicles on the road and trained people at every handover. Having these elements under one provider reduces the number of transfers and the number of parties who must be audited. Shippers interested in the wider picture can read more about temperature-controlled healthcare logistics in India and about how pharma supply chain services protect drug integrity.

How to Get Started

The onboarding process is designed to be short and specific. A shipper shares the product type, temperature requirement, shipment frequency, origin and destination, and delivery window. Reefer Express then carries out an assessment of the programme, proposes a route plan and packaging approach, and agrees reporting and escalation terms. Route availability and temperature bands are confirmed during this assessment, because requirements differ by therapy and by lane.

For new programmes, the company recommends a trial phase on the most demanding lane before volume is committed. A trial with loggers in every consignment gives the shipper real data on transit time, temperature performance and handover quality, and gives both parties a chance to refine the procedure. Readers who want a step-by-step view of good practice can refer to the guide on choosing a reliable cold chain transportation service for pharmaceuticals.

Frequently Asked Questions
What is cell and gene therapy logistics?

It is the specialised transport, storage and documentation of cell-based and gene-based treatments, including patient-specific products. The work involves strict temperature control, short transit windows, validated packaging and a complete chain of custody.

What temperatures do cell and gene therapy shipments require?

It depends on the product. Some move chilled, others frozen, and cryopreserved therapies may need ultra-low temperature conditions. The correct range comes from the manufacturer's specification, and packaging is chosen to match it.

Why is chain of custody important for advanced therapies?

Many of these products are made for one patient and cannot be replaced quickly. A complete record of who handled the shipment, when and where, supports regulatory compliance, product release decisions and investigation of any deviation.

How are temperature excursions handled?

Reefer Express follows a written escalation path that defines who is notified, in what order and within what time. The product is quarantined, the logger data is secured and the shipper's quality team decides on product disposition.

Can a trial shipment be arranged before a full programme starts?

Yes. A trial on the most demanding lane, with data loggers in every consignment, is recommended for new programmes. It shows how the service performs on the shipper's own route before volume is committed.

Request a Cell and Gene Therapy Logistics Assessment

Organisations that develop, manufacture or administer advanced therapies can request an assessment at [email protected] or through reefer-ex.in. Please include the product type, temperature requirement, expected volumes and lanes so the team can respond with a route-specific plan.

About Reefer Express
Reefer Express is a cold chain logistics company based in Hyderabad, India, providing temperature-controlled transportation and storage solutions for pharmaceutical, healthcare and other temperature-sensitive shipments. The company operates 12 warehouses with more than 130,000 pallets of storage capacity, a fleet of 50-plus vehicles, and coverage across 100-plus cities in India. Reefer Express supports pharmaceutical manufacturers, distributors and healthcare providers with validated packaging, monitored transport and documented cold chain handling.

Media Contact
Reefer Express
D. No. 1-18-29, First Floor, Rasoolpura, Begumpet, Hyderabad 500003, India
+91 97008 06504
[email protected]
https://reefer-ex.in/