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Next-generation therapies demand a next-generation R&D partner.

The Innovation CRO advantage of Veranex is purpose-built to overcome the unique challenges of combination products, drug delivery systems, and companion diagnostics. We solution-engineer with you to power your product from concept through commercialization.

Move vision to velocity. Turn risks into results. Deliver measurable patient impact.

Explore our Solutions

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Clinical trials demand more than data collection.

They require disciplined execution that transforms site information into evidence regulators trust. Veranex powers some of the industry’s biggest CROs and biopharma sponsors, translating site data into compelling, accurate, submission-ready evidence from Phases I–IV.

Clean data. Clear insights. Confident submissions.

Explore our Services

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Veranex Biopharma represents our dedicated focus on advancing new therapies, diagnostics, and delivery systems for biopharma innovators.

Behind every breakthrough is the full force of Veranex, the Innovation CRO built to bridge visionary science and market reality with proven expertise, agile execution, and an unwavering commitment to patient impact.

One company. Full integration. Biopharma breakthroughs accelerated.

Company

Cell Therapy Preclinical Studies:

Accelerating Discovery to Clinical Success

Expert-led preclinical studies to de-risk your therapeutic journey and expedite regulatory approval.

World-Class Cell Therapy Preclinical Expertise

Veranex preclinical services brings unparalleled expertise in cell therapy preclinical development, combining decades of scientific leadership with cutting-edge facilities and regulatory acumen. Our comprehensive approach to cell therapy testing encompasses everything from early-stage feasibility studies to complex GLP studies that support IND submissions.

Our team has successfully conducted preclinical studies across diverse cell therapy modalities including autologous, heterologous and allogeneic cell therapies, CAR-T cells, stem cell therapies, and tissue regeneration applications. 
50
+

Years of combined cell therapy preclinical experience

100
%

FDA-inspected and validated GLP facilities

100
%

State-of-the-art biosafety Level 2 containment capabilities

100
%

Regulatory submission success rate for completed studies

The Result

Specializing in large preclinical models and advanced imaging, we deliver essential data to move your cell therapy from preclinical proof-of-concept to first-in-human trials.

Our Experts Driving Preclinical Cell Therapy

Over the past decade, our team has supported preclinical studies across a diverse range of cell therapies, including autologous, homologous and heterologous, in both porcine and rodent models. Our cell therapy preclinical expertise is built on a foundation of scientific excellence, two of our Preclinical Senior Vice Presidents, Dr. Luc Behr and Dr. Nicolas Borenstein, earned their PhDs in cell therapy research, bringing unmatched depth of knowledge and expertise in surgical delivery techniques, translational large-animal models, and GLP-compliant execution to partner with clients developing next-generation cellular interventions.
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Nicolas Borenstein, DVM, PhD

Senior Vice President, Preclinical Services
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Luc Behr,                      DVM, PhD

Senior Vice President, Preclinical Services
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Sherry Farrugia

Senior Vice President
 
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Michael Sweet

Director, Preclinical Study Management

Comprehensive Cell Therapy Preclinical Services

From Early Feasibility to Regulatory Submission

Our cell therapy preclinical services are designed to address the unique challenges and regulatory requirements of cellular therapeutics. We provide end-to-end support throughout your preclinical journey, leveraging our specialized expertise and advanced capabilities to accelerate development timelines while ensuring the highest standards of scientific rigor.

Early Feasibility & Proof-of-Concept Studies

Early Feasibility & Proof-of-Concept Studies

Initial safety and efficacy assessments in relevant animal models to establish therapeutic potential and optimize delivery methods for your cell therapy approach.

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Dose-Ranging & Optimization Studies

Dose-Ranging & Optimization Studies

Comprehensive dose-response studies to identify optimal cell numbers, administration routes, and treatment protocols using advanced tracking and monitoring techniques.

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GLP Safety & Toxicology Studies

GLP Safety & Toxicology Studies

Regulatory-compliant safety assessments including biodistribution, tumorigenicity, and immunogenicity studies designed to support IND submissions and regulatory approval.

 

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Biostatistics and Statistical Programming

Biostatistics and Statistical Programming

Our Biostatistics and Statistical Programming transforms complex clinical data into regulatory gold, ensuring your research delivers the compelling evidence that drives approvals and patient access.

 

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Advanced Cell Tracking & Analysis

Advanced Cell Tracking & Analysis

Cutting-edge immunohistochemistry and molecular techniques to track cell fate, engraftment, differentiation, and therapeutic function in vivo.

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Delivery Device Integration

Delivery Device Integration

Combined testing of cell therapies with specialized delivery devices, catheters, and injection systems to optimize therapeutic delivery and clinical translation.

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Cell Therapy Device Development & Engineering

For clients developing cell therapy collection, processing, and delivery systems, Veranex's Product Design and Engineering group offers comprehensive device development services including automation of cellular processing workflows, cell isolation and sorting technologies, and therapeutic delivery platforms. Our integrated approach allows seamless coordination between device development and preclinical testing to accelerate your complete cell therapy solution. 

Learn more about Veranex Device Development Services →
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Not every CRO is
built for innovation.
Veranex is.

Scale from molecule to market, including the device.
Your therapy may require delivery, monitoring, or a diagnostic. We build and de-risk those solutions.

  • Concept development through clinical-ready builds
  • Device-specific regulatory, preclinical, and clinical
  • Commercial strategy and market access

All integrated into one team aligned to your goals.

Discover The Innovation CRO ↗
Case Studies

Proven Success in Cell Therapy Preclinical Development

Case_Study_CellTherapy

Cardiovascular Cell Therapy: Extracellular Matrix Technology Development

 

Situation

Supporting the development of extracellular matrix technology for cardiovascular regeneration applications across multiple therapeutic indications.

 

 

Success

The ECM technology has been successfully used in over 160,000 cardiovascular procedures across 975 hospitals in the U.S., including compassionate-use approval for pediatric applications.

 

Services by Veranex

  • GLP and non-GLP preclinical services
  • Biomaterial evaluation
  • Regulatory support

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Accelerate Your Cell Therapy Development with Veranex

Partner with the preclinical leaders who understand the complexities of cell therapy development. Our PhD-trained scientists, advanced facilities, and proven track record in regulatory submissions provide the expertise and capabilities you need to advance your cellular therapeutic to clinical success. From early feasibility through IND-enabling studies, we're your trusted partner in cell therapy preclinical development.
Discuss Your Cell Therapy Project