Redefining the pos·si·bil·i·ties

Developing the First and Only Bedside Cell & Gene Therapy delivery system



Making Life-Changing Therapies More
Accessible Across A Wider Range of Patients

Lupagen is the only medical device and services company dedicated to bedside cell and gene therapy

Our mission is to expand access to innovative therapies by lowering cost and simplifying delivery

Lupagen can help biopharma companies that are exploring alternative delivery solutions to address current development and market challenges


Lupagen’s Bedside Delivery System

Lupagen Xynvivo™ System collects the patient’s peripheral blood cells using standard leukapheresis process.

Binding to transgene viral vector or nanoparticle product occurs within the Xynvivo™ System and unbound particles are removed prior to reinfusion to the patient.

This entire process is done in a patient-connected closed loop procedure at the bedside in a few hours.


Extracorporeal Bedside Delivery Platform
with potential to improve Ex Vivo Cell
Therapy and In Vivo Gene Therapy

Ex Vivo Cell Therapy Companies

looking to expand access through a lower cost and simpler production process by migrating to an in-situ gene therapy approach

In Vivo Gene Therapy Companies

looking to accelerate their path to the clinic with an alternative route of administration that mitigates biodistribution challenges: accurate dosing, lower immunogenicity and off-target safety concerns

    • Potential Benefit
    • Ex Vivo
    • In Vivo

    Production Cost Savings

    Significantly reduces COGS and improves economics for biopharma companies, hospitals, and payers

    Obviates Cell Manufacturing

    Can convert complex and expensive ex vivo manufacturing processes to a simple bedside procedure

    Better Patient Experience

    Simple outpatient procedure providing affordable treatment and expanded patient access

    Enables Repeat Dosing

    Dosing flexibility due to simple, safe, and cost effective delivery platform

    Safer, More Effective Gene Therapy

    Controlled dosing can potentially mitigate organ toxicity, immunogenicity and off-target gene insertion


Lupagen is the only company dedicated to providing Extracorporeal Cell and Gene Therapy Delivery Technologies to the Biopharma industry

Cell and Gene Therapy is changing rapidly and becoming increasingly competitive as Biopharma companies pursue similar targets and diseases.

Lupagen’s extracorporeal delivery experts can collaborate with you to create and expand the value of your core cell and gene therapy program with a differentiated and accelerated path to the clinic.

Can your costly cell therapy benefit from extracorporeal delivery to address market access and competitive challenges?

How can your program prepare for challenges related to dosing, delivery and clinical effectiveness?

Does your program need assistance to surmount regulatory hurdles that may delay time to clinical and commercial stages?

Lupagen will be there every step of the way as your full-service delivery device partner from early stage preclinical through commercial.

1Available for preclinical research use.

2Customer therapeutic program requires regulatory authorization to use Lupagen Delivery System in clinical trials.

3Customer therapeutic program requires regulatory authorization to use Lupagen Delivery System for commercial use.

  • Extracorporeal delivery process development
  • Customized Customer Therapy protocol
  • Biocompatibility testing
  • Device related regulatory support (preIND/IND)
  • Device installation, training and technical support
  • Investigational kit supply
  • Extracorporeal delivery optimization for viral vectors and nanoparticle formulations
  • Clinical trial site device installation, training
  • Device technical support
  • Clinical trial validated kit supply
  • Kit delivery to clinical trial sites
  • Device related regulatory and IRB support
  • Product kit supply and delivery to treatment centers


In vivo CGT Company expanding indication reach through Extracorporeal delivery.

Customer Challenge

Systemic Administration of lentiviral vectors required high vector dose creating safety risks

Biotech company with an in situ lentiviral gene delivery vehicle needed a new route of administration that could control dose and limit unbound particles in vivo.

Lupagen Solution

Alternative route of administration that mitigates dosing challenges

  • Designed rapid feasibility testing to optimize lentiviral vector for use in Lupagen extracorporeal system.
  • Prepared for key regulatory agency meetings that provided clear guidance and path forward for bedside delivery of viral vector to generate CAR-T cells in vivo.

Biotech company now has a viable preclinical alternative to control dose and mitigate safety risks relative to other in vivo CAR-T cell programs

Key Services
  • Extracorporeal process optimization for lentiviral vectors
  • PoC Studies
  • Regulatory Agency Meetings

Biotech company with an Ex-Vivo Autologous Cell Therapy technology exploring Extracorporeal Delivery to expand patient access into new indications and markets

Customer Challenge

Biotech company’s central manufacturing process is too costly and complex limiting potential to address broader autoimmune indications

Biotech company with a first-in-class platform technology enabling the treatment of Autoimmune indications had developed a successful ex-vivo approach. However, the cost structure limits commercial viability in larger indications.

Lupagen Solution

Lupagen’s bedside extracorporeal approach presented an ideal alternative to bring cost of goods down to biologics pricing and ability to access larger patient populations and markets

Lupagen collaborated with customer to select and screen viral vector candidates that are optimized for extracorporeal delivery and develop studies to enable path to clinic.

Lupagen has provided Biotech company with a potential opportunity to expand into broader autoimmune indications driven by lower costs of goods and simpler production process compared to other CGT technologies

Key Services
  • In situ Lentiviral Vector Screening
  • Extracorporeal process optimization for lentiviral vectors
  • PoC Studies

Biotech Company expanding therapeutic opportunities to apply their mRNA platform technology into new indications and markets

Customer Challenge

Biotech company with novel mRNA technology is facing challenges with targeted delivery and repeat dosing for mRNA-based gene therapy.

mRNA therapeutics have the advantage of transient expression appropriate for chronic conditions but require ability to repeat dose. Biotech company needed a new route of administration that can significantly lower dose, mitigate biodistribution challenges and lower immunogenicity to enable repeat dosing.

Lupagen Solution

Alternative route of administration that mitigates dosing challenges

Lupagen collaborated with customer to select and screen lipid nanoparticle candidates that are optimized for in situ gene delivery and develop studies to help enable path to clinic.

Lupagen has provided Biotech company with a new potential regulatory and clinical pathway for an mRNA-based therapeutic by enabling controlled and repeat dosing

Key Services
  • Lipid nanoparticle Screening
  • Extracorporeal process optimization for LNPs
  • PoC Studies


Making A Difference: Who We Serve

Lupagen’s proprietary delivery technology is available to select biopharma companies developing CGT requiring targeted peripheral blood mononuclear cells for preclinical development

  • Selected Customer programs (non-exhaustive)
  • Therapeutic area
  • Gene delivery technology
  • CAR T-cell
  • Oncology
  • Lentiviral
  • Confidential
  • Autoimmune
  • Lentiviral
  • CAR T-Cell
  • Autoimmune
  • Lentiviral
  • CAR T-Cell
  • Oncology
  • LNP-mRNA
  • TCR
  • Oncology
  • Lentiviral
  • Gene Editing
  • Rare Disease
  • LNP-CAS9



Meet Our Team

Unleashing the value of bedside cell and gene therapies requires a diverse set of scientific, clinical and engineering expertise. We’ve assembled a team of innovators and executive leaders with decades of experience developing and bringing to market advanced cell and gene therapies.

Let’s redefine what’s
for cell & gene therapy