From Transduction to Treatment: Advanced Manufacturing for Next-Generation Therapies
At Elise Biopharma, we enable the future of medicine through cutting-edge cell and gene therapy (CGT) services. From GMP-grade viral vector production to ex vivo cell manufacturing and cryogenic logistics, we deliver end-to-end solutions designed for precision, safety, and speed.
Our facility is designed to support innovators developing curative, autologous, and allogeneic therapies—including CAR-T, NK, AAV, LVV, and emerging platforms. Whether you need a process established from scratch or scaled for clinical trials, we bring deep experience, regulatory know-how, and advanced biomanufacturing infrastructure.
Core Offerings
GMP Viral Vector Production
Scalable, High-Yield AAV & LVV Manufacturing Platforms
Gene therapy starts with precision viral vector production. Elise offers robust, scalable manufacturing platforms for adeno-associated virus (AAV) and lentiviral vectors (LVV), optimized for efficiency, purity, and regulatory compliance.
Capabilities include:
- Suspension and adherent-based AAV & LVV production (HEK293, Sf9/Baculovirus)
- 2 L to 200 L bioreactor capacity for scalable upstream campaigns
- GMP plasmid sourcing or in-house plasmid production (under ISO 13485)
- Transient transfection and stable producer line systems
- Vector engineering support for novel capsids and payload design
Purification & QC Highlights:
- Iodixanol gradient or affinity chromatography purification
- Benzonase treatment, tangential flow filtration (TFF), and sterile filtration
- Full genome and empty capsid ratio characterization
- Residual DNA, host cell protein, and endotoxin testing
- qPCR, ddPCR, infectivity, and potency assays
AAV Serotype Support: AAV1–AAV9, PHP.B, DJ, Anc80, and custom capsids
LVV Options: 2nd, 3rd generation systems; pseudotyping with VSV-G or RV-G
We support research-grade, GMP-like, and full GMP vector manufacturing—with seamless tech transfer between grades to accelerate IND readiness.
Ex Vivo Cell Therapy Manufacturing
Autologous & Allogeneic Cell Engineering for Immunotherapy
We offer a full suite of ex vivo cell manufacturing services under GMP, supporting autologous and allogeneic platforms such as CAR-T, CAR-NK, TCR-T, and engineered stem cell therapies.
Cell Types Supported:
- T cells (CD4⁺, CD8⁺, CAR-T)
- Natural Killer (NK) cells (expanded, CAR-modified)
- Mesenchymal stem cells (MSCs)
- Hematopoietic stem/progenitor cells (HSPCs)
Manufacturing Highlights:
- Apheresis material receipt, assessment, and chain-of-identity/chain-of-custody control
- Closed-system processing (CliniMACS, Sepax, Xuri, G-Rex, Quantum)
- Viral transduction (LVV, AAV) or non-viral methods (electroporation, transposons)
- Culture expansion and cytokine conditioning (IL-2, IL-15, IL-21)
- In-process testing for identity, viability, purity, and transduction efficiency
Potency & Safety Testing:
- Flow cytometry for surface markers and CAR expression
- Cytotoxicity assays (Luciferase-based, chromium release)
- Replication-competent virus testing (RCL, RCA)
- Mycoplasma, sterility, endotoxin testing
Batch Sizes: Clinical-grade manufacturing from 1 to 10 patient-specific lots per run
Release Timeline: Rapid-turnaround protocols enabling 7–10 day release for autologous therapies
Elise provides robust documentation for regulatory filing and a secure audit trail for chain-of-identity across all stages of cell processing.
Cryopreservation & Cold-Chain Logistics
Ultra-Low Handling, Global Distribution, Chain-of-Custody Precision
Advanced therapies demand meticulous control over every degree of the supply chain. Elise Biopharma integrates validated cryopreservation, real-time temperature tracking, and global logistics support into your cell and gene therapy workflow.
Cryopreservation Capabilities:
- Controlled-rate freezing using validated protocols (liquid nitrogen vapor phase or mechanical freezers)
- Formulation with DMSO, trehalose, or serum-free alternatives
- Vial- and bag-based formats with fill-volume accuracy and container-closure integrity (CCI) testing
- Compatible with cellular therapies, viral vectors, and stem cell banks
Cold-Chain Infrastructure:
- Liquid nitrogen storage (LN2 vapor-phase and liquid-phase options)
- -80°C and -196°C storage with redundant systems and 24/7 monitoring
- Validated packaging systems (CryoShippers, Credo, EVO, and Stirling passive containers)
- End-to-end shipment coordination via qualified cold-chain logistics partners
Digital Chain-of-Custody System:
- Barcode and RFID tracking of every unit
- Integrated electronic batch records (eBMR) and shipping manifest generation
- Alerts for temperature excursions and shipping milestones
Whether you need cryogenic hold for in-process materials or global distribution for GMP lots, Elise ensures your material arrives uncompromised—anywhere in the world.
Why Elise for CGT?
✅ End-to-End Platform
From plasmid DNA to finished drug product, Elise supports every stage of cell & gene therapy development, reducing tech transfer friction and timeline delays.
✅ Regulatory-Ready Systems
All GMP areas operate under ISO 9001 and ISO 13485, with cleanroom classifications up to ISO 5 and SOPs tailored for FDA, EMA, and MHRA readiness.
✅ Expertise Across Modalities
We support CAR-T, NK, AAV, LVV, and CRISPR-engineered therapies—alongside hybrid models like mRNA/LNP gene-modified cell products.
✅ Speed to Clinic
Rapid process establishment and flexible batch sizes enable partners to hit aggressive preclinical and Phase I timelines without sacrificing quality.
✅ Scalable Infrastructure
Pilot to Phase III scale capability with modular cleanroom pods and capacity reservations for your expansion plans.
Cleanroom & Facility Overview
| Feature | Specification |
|---|---|
| Cleanroom Suites | ISO 7 & ISO 5 classified rooms |
| Viral Vector Suites | Segregated AAV & LVV production rooms |
| Closed-System Cell Processing | CliniMACS Prodigy, Sepax, G-Rex, Xuri |
| Cryopreservation Infrastructure | LN2 vapor-phase, -80°C mechanical storage |
| QC & Release Labs | Mycoplasma, sterility, endotoxin, flow |
| Capacity | 10–15 lots/week (autologous); scalable |
Additional Support Services
- Tech Transfer & Process Development
Collaborative tech transfer planning with comparability protocols, process development, and bridging studies. - Regulatory Support & CMC Consulting
IND/IMPD drafting, BLA support, gap assessments, and agency meeting prep. - Assay Development & Bioanalytics
Potency, identity, and stability assay design and validation. - Long-Term Storage & Recall Readiness
Support for post-trial retention, sample retrieval, and chain-of-identity queries.
Partner With Elise
At Elise Biopharma, we understand that cell and gene therapy manufacturing is not just about science—it’s about lives, timelines, and precision. With our fully integrated CGT platform, we offer therapeutic developers a reliable, scalable partner that moves as fast as innovation demands.
📩 Ready to manufacture your vector or cell therapy?
Let’s design a solution that meets your science, your regulatory pathway, and your patients.