Nucelion

What Nucelion does

Nucelion Therapeutics Private Limited is a Cell & Gene Therapy (CGT) Contract Development and Manufacturing Organization (CDMO) headquartered in Genome Valley, Hyderabad, India, founded in 2025 as a wholly owned subsidiary of Bharat Biotech International Limited. The company provides an integrated suite of manufacturing and analytical services across the advanced therapy value chain, including plasmid DNA production (10-150L), viral vector manufacturing (AAV, lentiviral, retroviral) at 75-150L bioreactor scale, cell therapy manufacturing for autologous and allogeneic modalities (CAR-T, CAR-M, CAR-NK, HSCs, iPSCs, MSCs), non-viral gene delivery (LNP mRNA, CRISPR-Cas9), and exosome-based therapeutics. Supporting capabilities include molecular, protein/particle, cell-based, and microbiology/QC analytics, IND/IMPD-oriented CMC authoring, and single-threaded program management with weekly milestones, live dashboards, and monthly steering committee governance.

Nucelion serves biotech startups, pharmaceutical companies, and hospitals through three commercial engagement models: Fee-for-Service (defined scope, deliverables, and timelines), Collaborative Partnerships (joint development with shared responsibilities), and Co-Investment Structures (long-term risk- and equity-aligned partnerships). The ~30,000 sq ft facility integrates development labs, GMP suites, QC, and Fill-Finish under one roof with Grade B/A cleanrooms, BSL-2 vector and cell suites, and full cold chain infrastructure (2-8°C through LN2). Operations are supported by a validated digital stack (LIMS, eQMS, eBMR/eBR, CFR 21 Part 11) and ALCOA+ data integrity by design.

Despite parent affiliation, Nucelion operates independently with its own leadership and systems; programs for Bharat Biotech are conducted on third-party market terms with confidentiality, data segregation, and IP protection. Commercial leadership includes CBO Dr. Raghu Malapaka (PhD molecular biology, Harvard Medical School post-doc) with prior leadership roles at AGC Bio, Thermofisher, and WuXi. Pricing is quote-based with multi-year contracts; no revenue or backlog is publicly disclosed.

Name

Nucelion

Legal name

Nucelion Therapeutics Pvt. Ltd.

Website

https://nucelion.com

Company type

Private

Founded year

2025

Operating status

Operating

Headcount range

11–50 employees

Short description

Nucelion is a Hyderabad-based Cell & Gene Therapy CDMO offering integrated contract manufacturing services for plasmid DNA, viral vectors, and cell therapies. It serves biotech startups, pharmaceutical companies, and hospitals as a wholly owned subsidiary of Bharat Biotech International Limited.

Ownership category

akta.pro rank

Product category

Cell and Gene Therapy CDMO Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE)

akta.pro secondary industries

Cell Therapy CDMO (HLAGABAD), Gene Therapy Vector Manufacturing & CDMO Services (HLAAACAJ), Gene Therapy CMC/Process Development Platforms (capsid engineering, producer cell lines, plasmids, upstream/downstream) (HLAAACAN)

Keywords

• Cell therapy manufacturing
• Gene therapy CDMO
• Viral vector production
• Plasmid DNA manufacturing
• GMP biopharmaceutical services

Headquarters

HQ city

Hyderabad

HQ country

India

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Fee-for-Service CDMO: Traditional model with defined scope, deliverables, and timelines for CGT manufacturing services including plasmid DNA, viral vectors, and cell therapies.
2. Collaborative Partnerships: Joint development with shared responsibilities and risks for advanced therapy development and manufacturing.
3. Co-Investment Structures: Long-term partnerships with aligned financial interests to accelerate commercialization of cell and gene therapies.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Nucelion is a Cell & Gene Therapy CDMO offering contract development and GMP manufacturing services for plasmid DNA, viral vectors (AAV, Lentiviral, Retroviral), cell therapies (CAR-T, CAR-M, CAR-NK, HSCs, iPSCs, MSCs), non-viral gene delivery (LNP mRNA, CRISPR-Cas9), and exosome-based therapeutics at clinical scale. It also provides analytics, bioassays, CMC/regulatory documentation, and program management under integrated engagement models including fee-for-service, collaborative partnerships, and co-investment.

Product overview

Nucelion is a next-generation Cell & Gene Therapy CDMO offering an integrated platform of manufacturing and analytical services. The core product portfolio spans plasmid DNA manufacturing (non-GMP and GMP, 10–150 L scale), viral vector production (AAV, Lentiviral, Retroviral, 75–150 L bioreactors), cell therapy (CAR-T, CAR-M, CAR-NK, HSCs, iPSCs, MSCs including exosome-based solutions), and non-viral gene delivery (LNP mRNA, CRISPR-Cas9). These manufacturing capabilities are supported by Analytics & Bioassays services (molecular, protein/particle, cell-based, micro/QC testing), CMC/Regulatory & Documentation services, and Program Management (PMO). The company operates flexible working models including Fee-for-Service, Collaborative Partnerships, and Co-Investment Structures. All services are delivered through GMP facilities in Hyderabad, India with approximately 30,000 sft of development labs, GMP suites, QC, and Fill-Finish capabilities.

Differentiator

Problem solved

Functional benefit

Products and services

• Plasmid DNA Manufacturing Non-GMP and GMP plasmid DNA manufacturing supporting fermentation scales from 10–20 L for process development and 75–150 L for clinical-scale manufacturing, offered to biotech and pharma developers requiring high-quality plasmid input for viral vector and gene therapy programs.
• Viral Vector Manufacturing (AAV, Lentiviral, Retroviral) Production of AAV, Lentiviral, and Retroviral vectors using both adhesion and suspension cultures with 75–150 L bioreactors suited for clinical-scale output, provided to gene therapy developers requiring GMP viral vectors.
• Cell Therapy Manufacturing Manufacturing support for autologous and allogeneic cell therapies including CAR-T, CAR-M, CAR-NK, HSCs, iPSCs, and MSCs using automated closed-loop and traditional open-loop systems, plus exosome-based solutions, for biotech and pharma cell therapy developers.
• Non-Viral Gene Delivery Non-viral delivery platforms including LNP mRNA for gene and cell therapy applications and CRISPR-Cas9 gene editing capabilities, offered to developers seeking alternatives to viral vector delivery.
• Analytics & Bioassays Comprehensive analytical services including molecular (qPCR/ddPCR, residuals, NGS), protein/particle (ELISA, AUC/SEC-MALS, DLS, TEM), cell-based (potency assays, transduction efficiency), and micro/QC testing (sterility, mycoplasma, endotoxin, bioburden) for CGT developers.
• CMC, Regulatory & Documentation Services IND/IMPD-ready CMC authoring, batch records, CoAs, deviation/CAPA, change control, validation master plans, equipment qualification (URS/DQ/IQ/OQ/PQ), data integrity program (ALCOA+), eQMS workflows, and archival per GDP, delivered to biotech and pharma clients preparing regulatory submissions.
• Program Management (PMO) Single-threaded program ownership with weekly milestones, live dashboards (Gantt, Kanban), risk log with probability × impact, cost burn vs. deliverables, and governance with monthly Steering Committee and go/no-go gates, provided to clients managing complex CGT development programs.
• GMP Manufacturing Infrastructure Approximately 30,000 sq ft facility encompassing Dev Labs, GMP Suites, QC, Fill-Finish, Grade B/A cleanrooms, BSL-2 vector and cell suites, cold chain storage (2–8°C, -20°C, -80°C, LN2), and validated utilities, supporting clinical-scale GMP manufacturing for clients.

Quantifiable outcome

• Accelerated development timeline through integrated end-to-end approach
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Three partnerships are on record, tiered secondary and core.

• HospitalssecondaryOthersNucelion partners with hospitals for cell and gene therapy programs, providing manufacturing support for hospital-based CGT research and clinical applications.
• Biotech StartupscoreStrategic or Co-development PartnerNucelion partners with biotech startups developing novel cell and gene therapies, offering integrated CDMO services from process development through GMP manufacturing to accelerate their journey from discovery to clinical impact.
• Pharmaceutical CompaniescoreStrategic or Co-development PartnerNucelion provides contract manufacturing and development services to pharmaceutical companies seeking specialized CGT capabilities without building internal infrastructure.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Cellares: Emerging automated cell therapy manufacturing CDMO using its Cell Shuttle platform. Comparable as a next-generation cell therapy manufacturing provider targeting the same biotech innovator segment with a more automation-centric approach.

Broad incumbents

• Pharmaron: Integrated CRO/CDMO with biologics and CGT manufacturing capabilities including viral vector and cell therapy services. Comparable as a broader life sciences services provider offering CGT manufacturing within a wider portfolio of drug development services.
• Lonza: Global CDMO leader with extensive cell and gene therapy capabilities including viral vector and cell therapy manufacturing. Largest-scale competitor in the same CGT CDMO category where Nucelion operates, serving the same biotech and pharma clients but with much broader capacity and a global footprint.
• Catalent (Novo Holdings): Major CDMO with deep CGT capabilities in viral vectors, cell therapies, and plasmid DNA following its 2024 acquisition by Novo Holdings. Comparable as a full-service CGT CDMO serving biotech innovators and pharmaceutical companies with phase-appropriate GMP manufacturing.
• Charles River Laboratories: Established CRO/CDMO with end-to-end cell and gene therapy services including viral vector manufacturing, cell therapy, and plasmid DNA. Comparable as a diversified life sciences services provider serving the same biotech and pharma client base with overlapping CGT capabilities.
• Thermo Fisher Scientific (Patheon Pharma Services): Global life sciences services giant with pharma services spanning biologics, viral vectors, and cell therapy manufacturing. Comparable as a broad incumbent offering CGT CDMO capabilities; Nucelion's CBO also previously held a leadership role at Thermo Fisher.

Direct peers

• AGC Biologics: Specialized CDMO with dedicated cell and gene therapy services including viral vector and cell therapy manufacturing. Directly comparable as a mid-sized CGT CDMO serving similar biotech and pharma clients; notably, Nucelion's CBO previously held a leadership role at AGC Biologics.
• Resilience: CGT and complex biologics CDMO offering viral vector, cell therapy, and biologics manufacturing services. Comparable as a technology-focused CDMO serving biotech and pharma clients with phase-appropriate GMP capacity, similar to Nucelion's positioning.
• WuXi Advanced Therapies: Major CGT-focused CDMO offering viral vector and cell therapy manufacturing services. Directly comparable as a specialist CGT CDMO with a broad modality portfolio; also referenced in Nucelion's leadership background.
• Vibalogics: Specialized viral vector CDMO focused on oncolytic and gene therapy vectors for clinical and commercial supply. Directly comparable as a focused viral-vector CDMO serving similar biotech clients, though with a narrower modality range than Nucelion's full platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/nucelion-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nucelion