A cell and gene therapy facility in India needs GMP cleanrooms for aseptic processing, segregated space for viral vector work, a quality control lab, and liquid nitrogen cryostorage, all under one tight quality system. Unlike a tablet plant, each batch is often made for one patient, so the facility also has to track every sample from collection to infusion. Most of the design effort goes into contamination control and traceability, not floor area.
Why Is India Building CGT Capacity Now?
India approved its first homegrown CAR-T therapy, ImmunoACT’s NexCAR19, in 2023. CAR-T therapies take a patient’s own immune cells, modify them to attack cancer, and return them to the patient. Since then, more companies have moved CAR-T and other cell and gene therapies (CGT) into trials, and India’s lower manufacturing costs have drawn interest from global developers.
The rules are also clearer than they were. The New Drugs and Clinical Trials Rules, 2019 set the legal route for CGT trials, and ICMR has published national guidelines for gene therapy product development. Industry commentary still points to the same constraints: too few qualified facilities, imported raw materials, and a shortage of trained staff.
| Area | What Happens There | Key Requirements |
|---|---|---|
| Material receipt and apheresis intake | Patient cells arrive, are logged and checked | Chain-of-identity tracking, controlled temperature, secure access |
| Aseptic processing suites | Cell activation, gene modification, expansion and fill | Classified cleanrooms with pressure cascades, airlocks, gowning rooms, validated HVAC |
| Viral vector suite (if made in-house) | Production of the viral vectors used to modify cells | Separate HVAC and containment, segregated flows, dedicated equipment |
| QC laboratory | Sterility, mycoplasma, identity, potency and release tests | Separate from production, environmental monitoring, data integrity controls |
| Cryostorage | Storage of cells and final product in liquid nitrogen | Oxygen-depletion monitoring, liquid nitrogen supply, backup and alarms |
| Warehouse and dispatch | Media, reagents, single-use kits; shipping to hospitals | Temperature-controlled storage, cold chain packaging |
| Support | Gowning, waste, utilities, monitoring | Backup power, BMS/EMS, biosafety waste handling |
How Clean Do the Cleanrooms Need to Be?
That depends on how open your process is. Open aseptic steps, where product is exposed to room air, need the highest cleanliness zone, inside a highly classified background room.
Closed processing systems keep the product sealed in tubing and bags throughout. That can allow a lower-grade background room, which costs less to build and run.
This is why many new CGT facilities are designed around closed, automated platforms from day one. The design choice changes your cleanroom grades, gowning requirements, HVAC size and operating costs for the life of the plant. Settle your process platform before the facility design is frozen.
Should You Make Viral Vectors In-House or Buy Them?
Viral vectors are the delivery vehicles used to put new genes into cells. Making them in-house gives control over supply and cost, but adds:
A separate suite with its own HVAC and containment
More QC testing and specialist staff
Longer qualification and process validation
Many early-stage companies buy vectors from contract manufacturers and add an in-house vector suite once volumes justify it. If you plan to bring vectors in-house later, reserve space and utility capacity in the initial design.
How Long Does It Take to Get a CGT Facility Ready?
Construction is only part of it. Industry practitioners note that process validation alone can take 18 to 24 months, even for well-resourced teams. The usual sequence is:
Freeze the process platform (open or closed, manual or automated).
Write the user requirement specification for rooms, utilities and equipment.
Design and build the cleanrooms, HVAC and utilities, or fit out an existing GMP-ready shell.
Commission and qualify the facility and equipment (DQ, IQ, OQ, PQ).
Run environmental monitoring to show the rooms stay in specification.
Validate the process, including aseptic process simulations (media fills).
Prepare for inspection and the regulatory filings for your product.
Starting in a GMP-ready shell, with base HVAC, utilities and monitoring already in place, mainly shortens step 3. See our guide to lab build-out timelines in India for where those savings come from.
What Should You Check Before Choosing a CGT Site?
Can the building support a pressure cascade across several cleanroom grades?
Is there space and HVAC capacity for a separate vector suite, now or later?
Is backup power reliable enough for incubators and cryostorage?
Is liquid nitrogen supply secure, with safe delivery routes?
Can environmental monitoring data be exported for audits?
How far are the partner hospitals and apheresis centres?
How quickly can product reach an airport for cold-chain shipping?
Is there space to add suites as patient numbers grow?
Location matters more in CGT than in most manufacturing. Many products travel from patient to plant and back again, so distance to treatment centres and airports affects both cost and the time a patient waits.
Where Does NQF Hubs Fit?
NQF Hubs (NXT QST FWD) provides GMP-ready biomanufacturing modules, build-to-suit facilities and build-out services, including design, project management and GMP/GLP qualification support. Its Solutions page also lists central BMS/EMS integration, which matters for the continuous environmental monitoring CGT regulators expect.
For CGT developers, that can mean starting in a GMP-ready shell instead of building a cleanroom facility from bare land. Our earlier guide to bi
Frequently Asked Questions
What does a cell and gene therapy facility need?
Classified cleanrooms for aseptic processing, a quality control lab, liquid nitrogen cryostorage, and controlled storage and dispatch, plus a separate suite if you make viral vectors. It also needs systems to track each patient’s material from collection to infusion.
Which CAR-T therapies are approved in India?
India approved its first homegrown CAR-T therapy, ImmunoACT’s NexCAR19, in 2023. Several other Indian developers have CAR-T and other cell therapies in clinical development.
Do CGT facilities need Grade A cleanrooms?
Open aseptic steps need the highest cleanliness zone inside a classified background room. Closed processing systems can reduce the background room requirement, which lowers build and running costs.
How long does it take to set up a CGT manufacturing facility in India?
Building and qualifying the facility is only part of the timeline. Process validation can take 18 to 24 months on its own, so starting in a GMP-ready shell mainly shortens the construction stage.
Should a CGT startup build its own facility or use a CDMO?
Early-stage developers often use contract manufacturers while their process matures. Companies with a stable process, several products or growing patient volumes usually move to their own facility for control over cost and scheduling.
Call to Action
Planning a cell or gene therapy facility? Talk to NQF Hubs about GMP-ready space and build-out support. Get in touch.
6. External Sources Cited
BioSpectrum India, “CAR-T Therapy in India: Market challenges, opportunities and path to scalable manufacturing” (15 May 2026):
https://www.biospectrumindia.com/public/views/17/27824/car-t-therapy-in-india-market-challenges-opportunities-and-path-to-scalable-manufacturing.htmlICMR, “National Guidelines for Gene Therapy Product Development and Clinical Trials” (salient features):
https://www.icmr.gov.in/icmrobject/custom_data/1703071644_salient_features_gene_therapy.pdfWHO, TRS 1019 Annex 3, “Good manufacturing practices: guidelines on validation”:
https://www.who.int/publications/m/item/trs1019-annex3