Cell Therapy

Our associated Hospitals sites having GMP manufacturing facility for your development batches of CAR T, Gene therapy, etc. Very unique state of art facility in Washinton DC with patient pool for going with proof of concept or pilot clinical studies.

Below are cell therapy development facility set-up in development at USA and India and soon to provide full services.

Services

Development Batches & GMP Clinical Manufacturing

Our GMP manufacturing facility is purpose-built for advanced cell therapy production, ensuring compliance with FDA, EMA, and global GMP guidelines. We offer flexible, modular cleanroom suites for autologous and allogeneic CAR-T cell therapies, enabling rapid adaptation to your project needs.

Facility Features & Cleanroom Capabilities

  • ISO Class 7 & 8 Cleanroomswith Grade B/A critical areas for aseptic cell processing.
  • Dedicated Air Handling Units (AHUs)for contamination control.
  • Separate zones for patient-specific materialto maintain complete segregation and chain-of-identity integrity.

Available Equipment

  • Automated Cell Processing Systems:
  • CliniMACS Prodigy® (Miltenyi Biotec)
  • Cell expansion systems
    • Biosafety Cabinets (Class II)
    • Automated Cell Counters(Vi-Cell®, NucleoCounter® NC-202™)
    • Incubators with CO₂/O₂ Controlfor optimal T cell activation and proliferation
    • Closed-system Centrifugesfor safe handling of patient-derived materials
    • Electroporation & Transduction Systemsfor viral vector integration
    • Cryopreservation:
  • Controlled Rate Freezers (CRF)
  • Vapor-phase Liquid Nitrogen Storage

Process Capabilities

  • Apheresis Material Receipt & Qualification:Full incoming QC and viability assessment.
  • T Cell Isolation & Activation:Positive or negative selection depending on construct.
  • Genetic Modification:
  • Lentiviral or retroviral transduction under GMP
  • Electroporation for gene editing (e.g., CRISPR/Cas9 compatibility)
    • Expansion & Harvest:Closed-system bioreactors or static culture systems depending on phase and scale.
    • Formulation & Fill-Finish:Single-use, closed systems to reduce contamination risk.
    • Cryogenic Storage & Logistics:Integrated with GMP-compliant shipping solutions globally.

Testing Support (On-site or Partnered Labs

  • Sterility (USP <71>)
  • Endotoxin (LAL)
  • Mycoplasma
  • Replication Competent Virus (RCV) testing
  • Vector Copy Number Analysis
  • Cell Identity, Purity, Potency, and Viability

All processes follow stringent electronic batch record documentation (eBMR) and full traceability systems.

Scalability: From early-phase patient-specific batches to commercial-scale readiness, our flexible setup can grow with your clinical trial or commercialization plan.

Clinical Trial Collaboration with Hospitals (USA & India)

We provide comprehensive clinical trial collaboration services with leading hospitals, academic centers, and specialized oncology institutions across the United States and India to support CAR-T cell therapy development from early-phase clinical trials to commercial deployment.

Strategic Clinical Partnerships

USA

Partnerships with NCI-designated Cancer Centers, transplant centers, and top academic medical institutions renowned for pioneering CAR-T clinical research.

India

Collaborations with premier oncology hospitals, government medical institutions, and clinical research networks experienced in cell therapy trials.

These strategic alliances ensure that patients, clinicians, and trial sponsors benefit from seamless coordination between manufacturing, logistics, and clinical care.

End-to-End Clinical Support

Clinical Trial Design Support

  • Input on study protocols for CAR-T therapies, aligned with global regulatory standards.
  • Assistance with Investigational New Drug (IND)applications in the USA and Clinical Trial Applications (CTA) in India.

Clinical Site Engagement & Onboarding

  • Identification and onboarding of qualified clinical trial sites.
  • Site training programs on CAR-T handling, infusion protocols, and adverse event management.

Patient Journey Integration

  • Coordination of apheresis collectionat hospital sites.
  • Chain-of-custody management from collection through manufacturing to reinfusion.
  • Cryopreserved shipment solutionswith validated shipping containers to maintain product integrity.

Clinical Supply Chain Management

  • GMP-compliant logistics with real-time tracking of patient materials.
  • 24/7 support for critical shipment windows in collaboration with hospital infusion teams.
  • Contingency planning for international shipments, customs clearance (for India-USA transfers).

Commercial Launch Readiness

USA Commercialization

Partnerships with hospitals prepared for commercial CAR-T infusions. Reimbursement strategy planning with hospitals for Medicare/Medicaid and private payers. Integration with CAR-T Centers of Excellence to support standard-of-care adoption post-approval.

India Commercialization

Collaborations with leading cancer centers to establish CAR-T infusion units. Guidance on regulatory submissions with CDSCO (Central Drugs Standard Control Organization) and obtaining marketing authorization. Establishment of treatment pathways and pricing strategies tailored for the Indian healthcare ecosystem.

Data Integration & Outcome Reporting

  • Support for clinical data managementaligned with ICH-GCP guidelines.
  • Pharmacovigilance systems for post-infusion safety monitoring.
  • Integration with hospital electronic health records (EHR) for real-world evidence generation.

Why Partner with Us?

✅ Bi-continental Expertise (USA & India)
✅ Established Hospital Networks for Oncology & Hematology
✅ End-to-End Control of Cell Therapy Value Chain
✅ Commercial Scalability from clinical studies to market introduction

Bring Your CAR-T Therapy to Patients — Faster, Safer, and Globally Aligned.
Partner with us to build the future of personalized cancer care

Our Solution

An Integrated End-to-End Partnership

1. Process Development

We worked with the client’s R&D team to optimize their CAR-T production process, transitioning from academic protocols to automated, closed GMP-compatible systems. Using platforms such as CliniMACS Prodigy® and Sepax®, we reduced process variability by over 30%.

2. GMP Manufacturing

  • Phase I clinical-grade batcheswere produced in our Grade B/A GMP cleanrooms within 5 months of initiating the project.
  • Viral vector sourcingwas coordinated with a global supplier, ensuring high titers with QC release testing aligned with FDA guidelines.
  • Full electronic batch record (eBMR)systems ensured transparent documentation for regulatory submission.

3. Regulatory & Clinical Trial Execution

  • Supported the preparation of the IND (Investigational New Drug)submission in the U.S., leading to FDA clearance in a single review cycle.
  • Simultaneously, prepared a Clinical Trial Application (CTA)for the Indian market, working closely with local regulatory bodies (CDSCO).
  • Engaged two major hospital partners in the USAand three in India for parallel Phase I trials, leveraging our established clinical relationships.

4. Logistics & Cryopreservation

  • Enabled cryogenic shipmentof patient-specific CAR-T cells across continents using validated vapor-phase liquid nitrogen shippers.
  • Maintained full chain-of-identityacross sites, avoiding any product mix-up or delays.
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