A biosimilar manufacturing facility in India grows living cells, usually mammalian cells, in bioreactors to produce a protein drug, then purifies it through a chain of chromatography and filtration steps and fills it as a sterile injectable. It needs classified cleanrooms, segregated flows between upstream and downstream work, extensive quality control and tightly monitored utilities. The big early decision is single-use or stainless steel equipment, because it shapes the building for the next decade.
What is Biopharma SHAKTI?
In the Union Budget 2026-27, the government announced Biopharma SHAKTI, a Rs 10,000 crore programme over five years to make India a global hub for biopharmaceutical manufacturing. Its components include:
- R&D funding through discovery grants and equity funds
- A network of more than 1,000 accredited clinical trial sites under ICMR
- Three new NIPERs (National Institutes of Pharmaceutical Education and Research) and upgrades to seven existing ones
- A dedicated scientific review cadre at CDSCO
- Support for scaling manufacturing of biosimilars, biologics and advanced therapies
The message to industry is clear: the next phase of Indian pharma is biological, not just chemical. Many of the world’s best-selling biologics have lost or are losing patent protection, and Indian companies want a larger share of the biosimilar market that follows.
What makes biologics facilities different?
A chemical drug is made by a reaction. A biologic is made by living cells, and living cells are sensitive. Small changes in temperature, nutrients or contamination can change the product itself. That is why the saying “the process is the product” is taken seriously in biologics.
For the building, that means tighter control everywhere: air, water, temperature, people and materials.
What spaces does a biosimilar facility need?
| Area | What Happens There | What to Get Right |
|---|---|---|
| Cell Bank and Seed Train | Growing cells from frozen stock up to production volumes | Clean, controlled rooms, cryostorage, strict access controls |
| Upstream Production | Cells grow in bioreactors and produce the protein | Classified space, CO2 and oxygen supply, steam or single-use systems |
| Harvest and Downstream | Separating cells, chromatography, viral clearance, and filtration | Segregation between pre- and post-viral-clearance areas |
| Buffer and Media Preparation | Making large volumes of solutions | Purified water and water-for-injection systems, large tank space |
| Fill-Finish | Sterile filling into vials or prefilled syringes | Highest-grade aseptic zones, isolators, or barrier systems |
| QC Laboratories | Potency, purity, sterility, and characterisation testing | Separate laboratories, cell-based assay space, data integrity controls |
Single-use or stainless steel?
Single-use systems use disposable bags and tubing instead of fixed steel tanks. They need less cleaning and steam, switch between products faster and suit facilities making several biosimilars at modest volumes. The trade-off is ongoing spend on consumables and large storage for bags.
Stainless steel suits very high volumes of a single product. It needs clean-in-place and steam-in-place systems, more water for injection and more qualification work.
Many new Indian facilities choose single-use or a hybrid. It is faster to build and fits a portfolio of products, which is exactly how most biosimilar makers operate.
What should you check before choosing a site?
- Purified water and water for injection capacity, or space to add it
- HVAC able to support several cleanroom grades and segregated zones
- Warehouse space for single-use consumables
- Reliable power and backup for bioreactors and cryostorage
- Effluent treatment, including inactivation of biological waste
- Separate QC lab space with room to grow
- Space to add trains as more products come through
Where does a GMP-ready campus help?
Biologics plants are expensive and slow to build. Starting in a GMP-ready shell, with base HVAC, utilities and monitoring in place, means the project focuses on process equipment and qualification rather than foundations and plant rooms.
NQF Hubs (NXT QST FWD) provides GMP-ready biomanufacturing modules, built-to-suit facilities and turnkey build-outs with GMP qualification support, as set out on its Solutions page. Our guides to cell and gene therapy facilities and lab build-out timelines cover related ground.
Frequently asked questions
What is Biopharma SHAKTI?
It is a Rs 10,000 crore, five-year programme announced in the Union Budget 2026-27 to make India a global biopharmaceutical manufacturing hub, covering R&D, clinical trial sites, regulation and manufacturing.
What is a biosimilar?
A biosimilar is a biological medicine highly similar to an already approved biologic, with no meaningful differences in safety or effectiveness.
Should a biosimilar plant use single-use bioreactors?
Single-use systems suit multi-product plants at modest volumes and are faster to build. Stainless steel suits very high volumes of a single product.
What does a biologics facility need that a tablet plant does not?
Cell culture suites, cryostorage, water for injection, viral clearance segregation, aseptic fill-finish and cell-based quality control testing.
Planning biologics or biosimilar capacity? Talk to NQF Hubs about GMP-ready and built-to-suit space. Get in touch
6. External sources cited
- IMPRI, “Biopharma SHAKTI (2026): Strengthening India’s Biopharmaceutical Manufacturing”: https://www.impriindia.com/insights/policy-update/biopharma-shakti/
- News On AIR, “Government proposes Rs 10,000 crore Bio-Pharma Shakti scheme to strengthen biopharma sector” (2 Feb 2026): https://www.newsonair.gov.in/government-proposes-%e2%82%b910000-crore-bio-pharma-shakti-scheme-to-strengthen-biopharma-sector
- JLL, “India’s life sciences evolves from vaccines to innovation” (13 Apr 2026): https://www.jll.com/en-au/insights/india-life-sciences-evolves-from-vaccines-to-innovation