Cell-Easy Launches an iPSC-Derived Beta Cell Program to Tackle Scale-Up Challenges

L’article Cell-Easy Launches an iPSC-Derived Beta Cell Program to Tackle Scale-Up Challenges est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.

CHU Toulouse and Cell-Easy Launch A-MUSE, a Phase 1/2 Clinical Trial Evaluating the CellReady® Allogeneic MSC Platform in Systemic Sclerosis

Toulouse, January 22, 2026 — Cell-Easy, a CDMO specialized in the development and GMP manufacturing of Advanced Therapy Medicinal Products (ATMPs), announces a new clinical milestone achieved in close collaboration with Toulouse University Hospital (CHU Toulouse). The European Medicines Agency (EMA) has granted Clinical Trial Authorization (CTA) for AMUSE, a Phase 1/2 clinical trial evaluating the safety and efficacy of an allogeneic mesenchymal stromal cell (MSC) therapy in patients with systemic sclerosis presenting perioral fibrosis and functional impairment.

A-MUSE: Addressing a High Unmet Medical Need

Systemic sclerosis is a rare autoimmune disease characterized by progressive fibrosis, vascular dysfunction, and significant functional impairment. Perioral fibrosis is a particularly disabling manifestation, with a major impact on quality of life and no effective therapeutic options available to date.

The A-MUSE trial will assess whether local injections of allogeneic MSCs can reduce fibrosis, improve perioral mobility, and restore functional capacity. MSCs are known for their immunomodulatory, anti-fibrotic, and regenerative properties, supporting their clinical evaluation in this indication.

From Clinical Need to Cell Therapy Product: the Origin of CellReady®

The A-MUSE trial originates from a clinical initiative led by investigators at CHU Toulouse. Confronted with the absence of effective therapeutic options for patients with systemic sclerosis, the clinical team engaged Cell-Easy to assess the feasibility of developing a cell therapy product suitable for clinical evaluation.

In response, Cell-Easy designed and developed in 30 months a GMP-compliant MSC manufacturing platform tailored for clinical use. This platform, named CellReady®, enables standardized, regulatory-compliant, and cost-controlled manufacturing of MSCs. It is currently being evaluated across multiple therapeutic indications.

A Model for Rapid Clinical Translation

With A-MUSE, Cell-Easy illustrates its ability to translate a complex ATMP from early development to First-in-Human (FIH) clinical evaluation.

The CellReady® platform provides a foundation for future ATMP projects by enabling:

• CMC expertise to design and implement standardized, regulatory-compliant, and cost- controlled GMP manufacturing processes,
• short GMP manufacturing and batch release timelines (typically <3 months),
• well-structured CTA dossiers enabling rapid authorization (<6 months).

“CellReady® was conceived as a pragmatic response to clinicians’ needs,” said Guillaume Lay, Chief Commercial Officer at Cell-Easy. “A-MUSE shows how structured CDMO expertise can support the rapid transition from a clinical concept to a ready-to-use ATMP.”

“Our role is to help transform promising ATMP concepts into clinically actionable therapies,” added Cindy Cavelier, Cell-Easy Quality Person. “Whether originating from academia, startups, or biotech companies, we provide the operational, CMC, and regulatory framework required to reach patients in a controlled and compliant manner.”

About Professor Grégory Pugnet, Coordinating Investigator

Grégory Pugnet, M.D., PhD., coordinating investigator of the multicentric randomized control clinical trial (A-DUSE, NCT04356755, EU CT Number 2023-508432-53-00), is among the few specialists in systemic autoimmune disease; in which he is leading important clinical research activity. He worked for 18 months at the French Reference Center for Systemic Sclerosis in Cochin Hospital (Paris, France). He is an active member of the GFRS (Groupe Francophone de Recherche sur la Sclérodermie), and a member of the scientific committee of the French Reference Center for Cell Therapy in Autoimmune Diseases (MATHEC network), with the FAI2R network, labeled by the French Ministry of Health in 2017. Prof. Pugnet serves as the co-coordinator of the CLEIO network, which was awarded a label in 2025 by F-CRIN and the PNMR4. This comprehensive French national network is dedicated to facilitating both commercial and non-commercial trials of Advanced Therapy Medicinal Products (ATMPs) across various therapeutic areas and multiple specialties.”

About CIC-BT

The Clinical Center of Investigation in BioTherapy (CIC-BT 1436) is an academic organization under the supervision of Toulouse University Hospital (CHUT)/INSERM/University. It was established at the end of 2005 to support researchers and companies developing cell, gene and molecular therapy ATMPs, from the preclinical phases through to the coordination and conduct of phase 1-3 clinical trials. Its structure draws on the expertise of CHUT’s research and innovation department for regulatory aspects when CHUT is the study sponsor.

Coordinated by Prof. Louis Buscail, CIC-BT has been responsible for numerous projects, funded by a total of six million euros ($6.4M) (CHU promoter), including five national clinical research hospital programs – Programme Hospitalier de Recherche Clinique (PHRC) (2010, 2013, 2014, 2017 and 2022), three inter-regional PHRCs (2013, 2019 and 2022), one Horizon 2020 program, one SudOE program and two associations. CIC-BT also carries out extensive research in cardiovascular and digestive pathologies, in geriatrics and pediatrics, as well as translational research in collaboration with teams involved in regenerative medicine (RESTORE), neurodegenerative diseases (INFINITY), cardiovascular diseases (I2MC) and oncology (CRCT). www.chu-toulouse.fr

About Cell-Easy

Founded in 2017, Cell-Easy is a CDMO dedicated to advanced cell therapies. The company supports biotech and pharmaceutical companies worldwide through process and analytical development, GMP manufacturing, and CMC and regulatory support.

Cell-Easy works across multiple cell therapy modalities, including T cells, NK cells, macrophages, MSCs, HSCs, and immortalized cell lines, in oncology, autoimmune diseases, and regenerative medicine. Its science-driven teams apply Quality-by-Design principles to enable robust technology transfer and development.

Beyond conventional CDMO services, Cell-Easy provides access to clinical networks, human biological materials, and integrated CMC and regulatory expertise to support rapid clinical translation and efficient market access.

L’article CHU Toulouse and Cell-Easy Launch A-MUSE, a Phase 1/2 Clinical Trial Evaluating the CellReady® Allogeneic MSC Platform in Systemic Sclerosis est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.

CHU Toulouse and Cell-Easy Receive Regulatory Approval of A3D: A Phase 1 Trial Using CellReady® in Alzheimer’s Disease

Cell-Easy, a Contract Development and Manufacturing Organization (CDMO) specialized in advanced cell therapies, announces that its allogeneic adipose-derived mesenchymal stem cell product, CellReady®, will be investigated in a newly approved Phase 1 clinical trial for Alzheimer’s disease. The A3D trial has received authorization from the French National Agency for Medicines and Health Products Safety (ANSM), along with a positive opinion from the European Medicines Agency (EMA). A3D is sponsored and promoted by CHU Toulouse, in collaboration with the Clinical Investigation Center in Biotherapy (CIC-BT), and coordinated by Dr Julien Delrieu, Principal Investigator of the study.

A3D: Targeting Alzheimer’s Disease with Cell-Based Innovation

A3D (Adipose Adult stem cells in Alzheimer’s Disease) is a First-in-Human trial evaluating the safety and tolerability of intravenously administered allogeneic adipose-derived mesenchymal stem cells in patients with early-stage Alzheimer’s disease.

The study builds on growing preclinical and clinical evidence suggesting that mesenchymal stem cells (MSCs) can reduce neuroinflammation, modulate immune responses, and promote neurogenesis — offering a novel therapeutic approach in a field where current treatments remain largely symptomatic. Preliminary results from related studies, such as CRATUS, have shown encouraging cognitive and functional improvements in elderly individuals following MSC treatment, further supporting the potential of this strategy.

Cell-Easy: From Concept to Clinic — Fast

In the A3D study, Cell-Easy played a central role in bringing an innovative allogeneic MSC therapy to First-in-Human stage. As both

developer and GMP manufacturer of CellReady®, Cell-Easy delivered end-to-end support — from process development and scale-up to

clinical-grade production and regulatory documentation — enabling a swift transition to the clinic.

“This trial demonstrates how focused industrial expertise can directly accelerate clinical access,” said Guillaume Lay, Business Development Director at Cell-Easy. “Our CellReady® platform ensures scalable, compliant, and ready-to-use MSCs — a foundation for rapid clinical entry, even in complex indications like Alzheimer’s.”Guillaume Lay

Cell-Easy’s impact goes beyond a single trial. The same translational capabilities — GMP readiness, regulatory alignment, and real-world

delivery — apply to any cell therapy program. Whether autologous or allogeneic, early-stage or ready for trial, Cell-Easy enables

developers to move with confidence and speed toward clinical milestones.

About Professor Julien Delrieu, coordinating investigator

Julien Delrieu, M.D., PhD., principal investigator of the Phase I/II A3D clinical trial, is an Alzheimer disease specialist with an important clinical research activity. He decided to focus his clinical practice and research in the area of aging and Alzheimer disease, in particular the prevention of cognitive disorders. In 2008, he started working in the Toulouse Gérontopôle initially in the acute Alzheimer care unit and then head of the memory centre where we assess more than 1500 subjects per year. For more than 10 years, he has participated to major preventive trials in these fields (Multidomain Alzheimer Prevention Trial, NOLAN) and have published more than 90 scientific papers in peer reviewed journal. Currently, he is involved in the Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform to better understand the relationship between biological aging and age-related diseases as Alzheimer disease.

About CIC-BT

The Clinical Center of Investigation in BioTherapy (CIC-BT 1436) is an academic organization under the supervision of Toulouse University Hospital (CHUT)/INSERM/University. It was established at the end of 2005 to support researchers and companies developing cell, gene and molecular therapy ATMPs, from the preclinical phases through to the coordination and conduct of phase 1-3 clinical trials. Its structure draws on the expertise of CHUT’s research and innovation department for regulatory aspects when CHUT is the study sponsor. Coordinated by Prof. Louis Buscail, CIC-BT has been responsible for numerous projects, funded by a total of six million euros ($6.4M) (CHU promoter), including five national clinical research hospital programs – Programme Hospitalier de Recherche Clinique (PHRC) (2010, 2013, 2014, 2017 and 2022), three inter-regional PHRCs (2013, 2019 and 2022), one Horizon 2020 program, one SudOE program and two associations. CIC-BT also carries out extensive research in cardiovascular and digestive pathologies, in geriatrics and pediatrics, as well as translational research in collaboration with teams involved in regenerative medicine (RESTORE), neurodegenerative diseases (INFINITY), cardiovascular diseases (I2MC) and oncology (CRCT). 

www.chu-toulouse.fr

About Cell-Easy

Cell-Easy is a global Contract Development and Manufacturing Organization (CDMO) specializing in advanced cell therapies. We support biotech, pharma, and public institutions with GMP-compliant development and manufacturing.

Our mission: accelerate your cell therapy’s path to market — with patient access as the end goal.

The Cell-Easy team brings practical expertise across a wide range of cell types, engineered or not (T cells, NK cells, Macrophages, MSCs, HSCs, PSCs and any immortalized cell lines). Our services include process diagnostics, development, GMP production, cell banking, cryostorage, and delivery. We also assist with sourcing human biological materials and setting up clinical trials — enabling a smoother transition from concept to clinic. To date, Cell-Easy has supported 10 clinical trials, including collaborations with top 30 pharma, and guided clients in moving from autologous to allogeneic strategies.

L’article CHU Toulouse and Cell-Easy Receive Regulatory Approval of A3D: A Phase 1 Trial Using CellReady® in Alzheimer’s Disease est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.

Cell-Easy Expands its GMP Cell Therapy Manufacturing Facility to Support Growing Client Demand

New state-of-the-art class-B cleanrooms, development labs, and logistics upgrades accelerate scalable production of autologous & allogeneic cell therapies in compliance with FDA/EMA standards.

Cell-Easy, a leading European Contract Development and Manufacturing Organization (CDMO) specializing in cell therapy, today announced the expansion of its GMP manufacturing facility to support the growing needs of global Biotech and Pharma companies. The upgrade includes x5 Grade B cleanrooms, advanced process development labs, and an optimized warehouse with LN2 storage—strengthening end-to-end solutions for any ATMPs.

Key Enhancements for Scalable Cell Therapy Production

1. Expanded Development Laboratories

• Accelerated process optimization for adherent & suspension cell cultures.
• Enhanced analytical testing (e.g., potency assays, process characterization) to ensure product quality and regulatory compliance.

2. Five New Grade B Cleanrooms (Upgraded from Three)

• Dedicated to autologous and allogeneic cell therapy manufacturing.
• Equipped with advanced technologies compliant with FDA & EMA regulations.

3. Reengineered Warehouse with LN2 Infrastructure

• Improved cold-chain logistics with gaseous liquid nitrogen (LN2) storage for enhanced cell preservation.
• Fully compliant with global regulatory standards.

“This expansion solidifies Cell-Easy’s role as a strategic partner in Cell Therapy,” said Alexis Delbaere, CEO of Cell-Easy. “By integrating scalable infrastructure with stringent quality systems, we empower developers to transition seamlessly from preclinical to clinical manufacturing—reducing time-to-market for life-saving therapies.”

Why it Matters

The enhanced facility optimizes material flow, personnel efficiency, and product traceability, critical for cell therapy CDMOs delivering GMP-grade materials worldwide. With this investment, Cell-Easy reinforces its commitment to:

• Faster turnaround times for clinical & commercial batches.
• Flexible, scalable solutions for CAR-T, iPSCs, and gene-modified therapies.
• End-to-end support from process development to fill-finish.

About Cell Easy

Cell-Easy is a science-driven Contract Development and Manufacturing Organization (CDMO) specializing in cutting-edge cell therapies. We empower Biotech and Pharmaceutical companies with end-to-end solutions to accelerate the development, GMP manufacturing, and commercialization of innovative cell-based treatments, from preclinical stages to clinical approval.

Comprehensive Cell Therapy CDMO Services

Our expertise covers the entire cell therapy value chain, including:

• Process & Analytical Development: Optimized workflows for T cells, NK cells, MSCs, HSCs, macrophages, and other immortalized cell lines.
• GMP Manufacturing: Scalable, FDA/EMA-compliant production for autologous & allogeneic therapies.
• CMC & Regulatory Support: Streamlined documentation and compliance for faster IND/IMPD submissions.

Why Partner with Cell-Easy?

• Modality-Agnostic Expertise: Proven experience across oncology, autoimmunity, and regenerative medicine.
• Quality by Design (QbD): Rigorous approach to ensure process robustness, scalability, and regulatory success.
• End-to-End Integration: Guiding cell therapy innovators from concept to clinical trials in France, Europe’s leading advanced therapies market, through seamless tech transfer and GMP manufacturing.

For more information on Cell-Easy’s cell therapy CDMO services, visit https://www.cell-easy.com or contact: info@cell-easy.com .

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CTA Approval to initiate ALLOFIST

CHU Toulouse receives CTA Approval to initiate ALLOFIST, a Phase 1/2 Trial based on Cell-Easy’s proprietary adipose-derived MSC in Patients suffering from Crohn Disease.

The long-term partnership between Cell-Easy and Toulouse University Hospital (CHU Toulouse) continues to bear fruits, bringing innovative MSC-based therapies to local patient cohorts. This time, it’s in the field of Crohn’s disease that the pair is experimenting with the allogeneic cell therapy approach. By tackling all CMC, regulatory and medico-economic concerns, the Cell-Easy CDMO has succeeded in developing a cell therapy drug from scratch in just 2 years. The principal investigator Dr Etienne Buscail, a colo-rectal surgeon and proctologist at Toulouse University Hospital, recently submitted a request for authorization of CTA to the European Agency EMA, which was rapidly accepted. An initial cohort of patients suffering from Crohn’s disease will be able to benefit from this experimental innovant treatment starting in 2025 Q1.

CHU Toulouse is sponsoring a bicentric clinical project entitled “ALLOFIST” a Phase I/II study of dose-escalation cell therapy for the treatment of ano-perianal fistulas associated with Crohn’s disease, using intrafistular injection of allogeneic Adipose derived Stroma/Stem Cells (AdMSC), registered under number RC31/13/7030, coordinated by Dr. Etienne BUSCAIL (Colo rectal surgeon and proctologist).

Perianal fistulas are in the forefront of morbid complication of Crohn’s disease, affecting nearly one-third of patients and complicating abscesses in 35-48% of cases. The current treatment is based on the combination of drainage (proctologic and surgical), and biologics techniques, but the failure rate varies from 30 to 80%. Cell therapy, and more specifically allogenic mesenchymal stem cells, represent a promising option in the treatment of perianal fistulas associated with Crohn’s disease thanks to their immunomodulatory, anti-inflammatory, angiogenic and trophic properties. This Phase I/II study aims to evaluate the safety and efficacy of AdMSC for the treatment of complex perianal fistulas associated with Crohn’s disease, following the failure of conventional therapies. Different doses of AdMSC will be tested for a dose escalation (5.10*7 and 10.10*7 cells).

The use of AdMSC in different disease areas was born from the initial ambition of local clinicians to offer cutting-edge therapeutic solutions to patients. Cell-Easy, a cell therapy expert CDMO with a strong track record in stem cells, developed CellReady®, a robust  allogenic process providing the necessary AdMSC doses for ALLOFIST and other clinical studies. It took the French CDMO, 24 months to meet the challenge faced by startups and biotechs worldwide: completing the pharmaceutical development, scaling up the process, and manufacturing an injectable cell product for human use while adhering to the regulatory requirements and minimizing the dose-cost.

The pharmaceutical development strategy employed by Cell-Easy has not only met clinicians’ expectations regarding the quality of the drug product (safety, identity, and potency) but has also considered the economic aspects of these costly therapies. By scaling-up the AdMSC manufacturing process, Cell-Easy has enabled a significant increase in production volume, effectively reducing CellReady® dose costs.

“As a reliable CDMO player, it is essential to provide complete satisfaction to both cell therapy Biotechs developers by meeting their timelines and budgets, as well as to Clinicians who demand GMP-controlled manufacture of ATMPs in line with regulatory requirements. This partnership once again demonstrates Cell-Easy’s thorough understanding of the needs of Cell Therapy stakeholders, enabling the implementation of a safe and timely First-in-Human (FiH) access plan.” _ Guillaume Lay, CCO Cell-Easy.

About Etienne Buscail, coordinating investigator

Etienne Buscail MD PhD is a colorectal surgeon and proctologist at the Toulouse University Hospital. He specializes in the management of inflammatory bowel disease as part of a reference team for the management of inflammatory bowel disease. He has developed a specific expertise in the management of anal fistulas, particularly in Crohn’s disease. Dr Etienne Buscail is a member of the national research team of rectal cancer (GRECCAR), inflammatory bowel disease surgery (GETAID Chirurgie), and proctology (SNFCP). His areas of research are: colorectal cancer, pathological inflammatory processes of the intestine and anus. He is a member of the Institute of Digestive Health Research (IRSD), INSERM U 1220. He has led several clinical and translational studies on digestive cancer and inflammatory phenomena of the digestive tract.

About CIC-BT

The Clinical Center of Investigation in BioTherapy (CIC-BT 1436) is an academic organization under the supervision of Toulouse University Hospital (CHUT)/INSERM/University. It was established at the end of 2005 to support researchers and companies developing cell, gene and molecular therapy ATMPs, from the preclinical phases through to the coordination and conduct of phase 1-3 clinical trials. Its structure draws on the expertise of CHUT’s research and innovation department for regulatory aspects when CHUT is the study sponsor.

Coordinated by Prof. Louis Buscail, CIC-BT has been responsible for numerous projects, funded by a total of six million euros ($6.4M) (CHU promoter), including five national clinical research hospital programs – Programme Hospitalier de Recherche Clinique (PHRC) (2010, 2013, 2014, 2017 and 2022), three inter-regional PHRCs (2013, 2019 and 2022), one Horizon 2020 program, one SudOE program and two associations. CIC-BT also carries out extensive research in cardiovascular and digestive pathologies, in geriatrics and pediatrics, as well as translational research in collaboration with teams involved in regenerative medicine (RESTORE), neurodegenerative diseases (INFINITY), cardiovascular diseases (I2MC) and oncology (CRCT). www.chu-toulouse.fr

About Cell-Easy

Cell-Easy is a global Contract Development and Manufacturing Organization (CDMO) with a dedicated focus on advanced cell therapies. Established in 2017, Cell-Easy’s commitment extends beyond development and manufacturing; it also places a strong emphasis on regulatory and CMC requirements.

Cell-Easy is a science-driven CDMO specialized on advanced Cell Therapies. Cell-Easy offers a broad range of Services, including Process and Analytical development, GMP manufacturing and CMC/Regulatory support for global  Biotechs & Pharmas. The scientific team and QbD approach enable seamless technology transfer and development for cell-based therapies in the fields of oncology, autoimmune diseases and regenerative medicine (T cells, NK cells, Macrophages, MSCs, HSCs and exosomes).

In addition to its role as a conventional CDMO, Cell-Easy provides a range of added-value services, including: i) access to patients through an extensive network of national clinicians, ii) access to the human biological materials necessary to produce cell therapies, and iii) comprehensive CMC and regulatory support to accelerate the market approval of these cutting-edge therapies.

L’article CTA Approval to initiate ALLOFIST est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.

Mastering Cell Bank Development and Manufacturing Services for US Pharma company

Cell-Easy Expands US Footprint with Key Contract Signing for Master Cell Bank (MCB) and Working Cell Bank (WCB) Manufacturing Services.

Cell-Easy, a European Contract Development and Manufacturing Organization (CDMO) specializing in Cell Therapy, announces a significant milestone with the signing of a Cell Bank Development and Manufacturing services contract with a prominent US-based pharmaceutical company. This partnership solidifies its position as a trusted expert in cell-based product development and manufacturing services.

Human cell banking plays a critical role in advancing cell-based therapies, serving as the foundation for product development, regulatory approval, and commercialization. However, the process presents challenges, including maintaining cell viability, ensuring genetic stability, and adhering to stringent regulatory requirements. Addressing these challenges requires expertise in cell culture, cryopreservation, and quality control, along with access to validated providers and scalable manufacturing capabilities.

Cell Easy was chosen for its expertise in the above-mentioned fields:

• Track record in Cell-Banking: With numerous Cell Banking projects in different cell types using various technologies, Cell-Easy had the track record to convince on its ability to scale-up the process and safeguard cells using the suitable freezing strategy.
• Managing international supply chains: Cell-Easy has established a network of validated providers to ensure the safe and efficient delivery of cell products, even cross-Atlantic.
• Competitive Costs: Finding the best path forward, Cell-Easy’s process development experts have been able to streamline the process, reducing the overall costs without compromising on quality. Reduction in manpower, raw material and clean room booking have all been instrumental in providing cost-effective solutions while maintaining the highest standards of excellence in cell bank manufacturing.

By engaging customers in conversations about their current status, needs, and future goals, we effectively tailor proposals to offer diverse pathways forward and fine-tune project scopes to accommodate their constraints. This not only adds tangible value for prospects but also showcases our depth of understanding and expertise. Ultimately, it optimizes the return on investment for their expenditure. This science-driven approach has been instrumental in successfully penetrating the US market.

About Cell-Easy

Cell-Easy is a science-driven CDMO specialized on advanced Cell Therapies.

Cell-Easy offers a broad range of Services, including Process and Analytical development, GMP manufacturing and CMC/Regulatory support for global  Biotechs & Pharmas.

The scientific team and QbD approach enable seamless technology transfer and development for cell-based therapies in the fields of oncology, autoimmune diseases and regenerative medicine (T cells, NK cells, Macrophages, MSCs, HSCs and exosomes)

Explore our services at https://www.cell-easy.com and don’t hesitate to contact us at info@cell-easy.com

L’article Mastering Cell Bank Development and Manufacturing Services for US Pharma company est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.

Cell-Easy Signs Groundbreaking Manufacturing Contract, Paving the Way for Local Hospitals to Offer Next-Generation CAR-T Therapy

This agreement with a pioneer European C&G company will soon enable the initiation of new clinical trials in South of France based on innovative CAR-T cell treatments

The French Contract Development and Manufacturing Organization (CDMO) Cell-Easy stands out and achieves a new milestone by
securing a service contract aimed at producing multiple autologous CAR-T cell-based treatments. The biocluster recently formed by
Toulouse players (MoU signed between Cell-Easy and the Oncopole Claudius Régaud, OCR) is already bearing fruit and will enable
patients with certain forms of liquid cancer to access new generations of CAR-T cell therapies.

Advancements in CAR-T cell therapies have been swift, with approvals granted for a spectrum of applications. Notably, these therapies have demonstrated exceptional efficacy in combatting certain blood cancers. Nevertheless, developers of autologous CAR- T cell therapies must adapt their strategies to account for complexities in regulatory pathways, patient access, and manufacturing/logistic processes. 

Collaboration with strategic partners, including CDMOs and healthcare providers, can provide CAR-T cell developers with expertise, resources, and infrastructure to accelerate clinical trials initiation while managing costs. The Toulouse-based CDMO Cell-Easy, an expert in the development and manufacturing of cell-based therapies, has been selected for these reasons, notably:

• CMC and Regulatory support.
• Reactivity to manufacture swiftly after patient inclusion.
• Clinician network.

About Cell-Easy

Cell-Easy is a science-centric CDMO specialized on advanced Cell Therapies. Cell-Easy offers a broad range of Services, including Process and Analytical development, GMP manufacturing and CMC/Regulatory support for global Biotechs & Pharmas. The scientific team and QbD approach enable seamless technology transfer and development for cell-based therapies in the fields of oncology, autoimmunity, and
regenerative medicine (T cells, NK cells, Macrophages, MSCs, HSCs and exosomes) Explore our services at www.cell-easy.com – Nouvelle fenêtre and don’t hesitate to contact us at info@cell-easy.com

About OCR

The IUCT-Oncopole, a cancer care, research and training center in Toulouse, combines the expertise of 1,800 professionals on a single site labeled “Comprehensive Cancer Center”. It includes several state-of-the-art clinical facilities for the treatment of cancer with a world-class research infrastructure, on an integrated campus that brings together public and private stakeholders, including industrial partners. The IUCT-Oncopole, which includes Oncopole Claudius Regaud and several teams from the Toulouse University Hospital (CHU), treats more than 10,000 new patients every year, and more than one in eight patients is enrolled in clinical studies.

The accumulated expertise among various programs as well as our local partnerships have been the foundation to close such a deal. I’m a true believer that our positioning can be beneficial for other biotech seeking to easily access patient cohorts.Alexis Delbaere – Nouvelle fenêtre

L’article Cell-Easy Signs Groundbreaking Manufacturing Contract, Paving the Way for Local Hospitals to Offer Next-Generation CAR-T Therapy est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.

Accelerating Patient Access to Advanced Cell-based Therapies through the Signature of a Service Agreement between the French CDMO and the Toulouse University Hospital (CHU Toulouse)

Accelerating Patient Access to Advanced Cell-based Therapies through the Signature of a Service Agreement between the French CDMO and the Toulouse University Hospital (CHU Toulouse)

This agreement between the two parties opens great perspectives for Biotechs, providing them with seamless access to patients who will benefit from innovative cell therapy products. In the race to offer promising new cell-based therapies for unmet medical needs, the French Contract Development and Manufacturing Organization (CDMO) Cell-Easy makes available its GMP manufacturing capabilities to create a cluster of local Point-of-Care sites. This represents a great opportunity for Biotechs and Pharmas looking for new centers of investigation, and more importantly, an additional chance for patients waiting for new therapeutic options.

Thanks to its Clinical Center of Investigation in BioTherapy (CIC-BT), CHU Toulouse stands as a pioneering player in Cell Therapy within France.

As life expectancy increases, so does the number of patients suffering from incurable diseases. Local hospitals have been diligently investigating novel therapeutic solutions among these patients. Meanwhile, Biotech and local R&D centers are developing therapies that are increasingly innovative, but also increasingly complex to produce and advance to clinical stage. The Toulouse-based CDMO Cell-Easy, an expert in the development and clinical-grade production of cell drug products, was identified as a critical link in this value chain.

In practical terms, the recent agreement between the two partners will :

• facilitate access to patient cohorts necessary for clinical trials
• speed up the lengthy administrative and legal procedures associated with clinical trials.
• Improve the likelihood of success of clinical studies, by involving expert CGT (Cell & Gene Therapy) players.

This alliance consolidates Cell-Easy’s position as a major player in Biotherapy in France and beyond. Our state-of-the-art facility and the highly experienced team give great opportunities for Biotechs & Pharmas developers.Guillaume Costecalde, Chaiman

About Cell-Easy

Cell-Easy is a science-centric CDMO specialized on advanced Cell Therapies.

Cell-Easy offers a broad range of Services, including Process and Analytical development, GMP manufacturing and CMC/Regulatory support for global  Biotechs & Pharmas.

The scientific team and QbD approach enable seamless technology transfer and development for cell-based therapies in the fields of oncology, autoimmune diseases and regenerative medicine (T cells, NK cells, Macrophages, MSCs, HSCs and exosomes)

Explore our services at https://www.cell-easy.com and don’t hesitate to contact us at info@cell-easy.com

About CHU Toulouse

With +300.000 patients per year and 16000 employees, the CHU Toulouse is the 4^th largest hospital in France. In partnership with the Toulouse Faculty of Health, the CHU contributes to the continuous improvement of care through extensive research and innovation.

About CIC-BT

The CIC-BT is an academic organization supporting researchers and companies developing Cell, Gene and Molecular therapies, from preclinical to late clinical phases in cardiovascular, digestive pathologies, in geriatrics and pediatrics, as well as translational research.

www.chu-toulouse.fr

L’article Accelerating Patient Access to Advanced Cell-based Therapies through the Signature of a Service Agreement between the French CDMO and the Toulouse University Hospital (CHU Toulouse) est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.

IMPD Approval for FIH Trial in Systemic Sclerosis – Cell Easy

EU regulatory approval to administer Adipose-derived mesenchymal Stem Cells (ASCs) in patients with ischemic digital ulcers marks key milestone for partners

Cell-Easy, a French Contract Development and Manufacturing Organization (CDMO) focused on advanced cell therapies, and the Toulouse University Hospital, today announce that they have obtained IMPD (Investigational Medicinal Product Dossier) approval for a first-in-human clinical trial. This trial will use an allogeneic treatment, developed from an autologous process, for patients with ischemic digital ulcers in systemic sclerosis. The CDMO developed the entire manufacturing process from an initially autologous one where the cell donor was the patient himself.

The innovative allogeneic approach uses cells from a single donor to produce therapeutic doses for thousands of patients. This is cost-efficient, therefore it makes the product more accessible for patients.

Cell-Easy has conceived and designed a process for the large-scale manufacturing of ASCs in compliance with the GMP (Good Manufacturing Practice) standards required by regulatory agencies. These ASCs will be used in the A-DUSE clinical trial. Prof. Gregory Pugnet, from the Internal Medicine and Clinical Immunology department, Rangueil Hospital, Toulouse, (France) is the main investigator of the trial, which is sponsored by Toulouse University Hospital.

Gaining ANSM/EMA’s approval for the A-DUSE clinical trial is a demonstration of the Cell-Easy team’s ability to carry out a cell therapy development program from end to end. Some highlights from the new large-scale manufacturing process of therapeutic doses of allogeneic ASCs: 

• >5,000 doses per tissue donation
• >4.10⁹ cells per batch
• x20 cost reduction
• 26 parameters analyzed per batch

The Toulouse University Hospital, through its clinical center of investigation in biotherapy (CIC-BT) structure, stands as a pioneering cell therapy player in Europe. It has 20 years’ experience in the field of cell therapy based clinical research. In a bid to kickstart the A-DUSE clinical trial safely and efficiently, Prof. G. Pugnet was looking for a robust industrial partner capable of providing high numbers of clinical grade ASC therapeutic doses. The scientific, technical and regulatory expertise of the French CDMO, and its ability to offer an end-to-end service spanning from patient sample procurement through to IMPD writing, convinced the Toulouse study center.

“This project represents another remarkable milestone for Cell-Easy, demonstrating our ability to successfully navigate the entire life cycle of Advanced Therapy Medicinal Products (ATMP) development. Our collaborative work with physicians, supply chain partners, regulators and policymakers has enabled us to effectively address the intricacies of these therapies and establish rigorous quality standards,” said Guillaume Costecalde, president at Cell-Easy.

Beyond conventional GMP manufacturing of ASCs, the A-DUSE clinical trial required the selected partner to provide unfailing support in terms of regulatory and scientific matters, as well as medico-economic understanding of the disease. Close collaboration between Cell-Easy, CIC-BT and Prof. G. Pugnet was instrumental in achieving this objective.

In less than 20 months, Cell-Easy developed a new production process in ASC along with all the associated analytical tests for robust batch qualification.

Within the framework of this partnership, the resources made available by the CDMO have resulted in:

1. Establishment of partnerships with local healthcare centers capable of selecting donors based on medical-biological criteria, of supplying human adipose tissue and of qualifying donations at GMP level, as required by EU/US regulatory agencies
2. Conducting toxicity and tumorogenicity studies in mice, and
3. Co-authoring the IMPD for submission to the local French agency, the ANSM

Injection of allogeneic ASC, a promising opportunity for healing digital ulcers

Systemic sclerosis is an orphan disease characterized by the development of microangiopathies and progressive fibrosis. Digital Ulcers (DUs) are common in the course of the disease and are an expression of its severity. Not only do DUs cause intense pain and hand disability, but more critically they can lead to infections that can result in gangrene and eventual amputation. With optimal standard of care only 60% of DUs are healed after three months and 46.2% experience recurrence during this period, with 11.2% having a chronic course. To date, no medication has demonstrated a positive effect on the healing of refractory DUs. In this clinical context with no therapeutic alternative, the partnership between Toulouse University Hospital, represented by Prof. G. Pugnet, the CIC-BT, and Cell-Easy, through the A-DUSE Clinical Trial (digital injection of allogeneic ASC), represents a promising opportunity for many patients in the healing of refractory ischemic DUs.
Since 2021, French players in biotherapy have been working hard to convert a promising MSC-based therapy concept into reality for patients living with ischemic digital ulcers due to systemic sclerosis.

About Grégory Pugnet, coordinating investigator
Grégory Pugnet, M.D., PhD., coordinating investigator of the multicentric randomized control clinical trial (ADUSE, NCT04356755, EU CT Number 2023-508432-53-00), is among the few specialists in systemic autoimmune disease; in which he is leading important clinical research activity. He worked for 18 months at the French Reference Center for Systemic Sclerosis in Cochin Hospital (Paris, France). Pugnet is an active member of the GFRS (Groupe Francophone de Recherche sur la Sclérodermie), and a member of the scientific committee of the French Reference Center for Cell Therapy in Autoimmune Diseases (MATHEC network), with the FAI2R network, labeled by the French Ministry of Health in 2017. Grégory also actively participates in CIC-BT, coordinated by Louis Buscail, and has secured funding for three ASC-based cell therapy projects in scleroderma (A-DUSE, A-MUSE) and neuroinflammatory muscular diseases (A-NEMIS) in collaboration with CIC-BT and Cell-Easy.

About CIC-BT
The Clinical Center of Investigation in BioTherapy (CIC-BT 1436) is an academic organization under the supervision of Toulouse University Hospital (CHUT)/INSERM/University. It was established at the end of 2005 to support researchers and companies developing cell, gene and molecular therapy ATMPs, from the preclinical phases through to the coordination and conduct of phase 1-3 clinical trials. Its structure draws on the expertise of CHUT’s research and innovation department for regulatory aspects when CHUT is the study sponsor.
Coordinated by Prof. Louis Buscail, CIC-BT has been responsible for numerous projects, funded by a total of six million euros ($6.4M) (CHU promoter), including five national clinical research hospital programs – Programme Hospitalier de Recherche Clinique (PHRC) (2010, 2013, 2014, 2017 and 2022), three inter-regional PHRCs (2013, 2019 and 2022), one Horizon 2020 program, one SudOE program and two associations. CIC-BT also carries out extensive research in cardiovascular and digestive pathologies, in geriatrics and pediatrics, as well as translational research in collaboration with teams involved in regenerative medicine (RESTORE), neurodegenerative diseases (INFINITY), cardiovascular diseases (I2MC) and oncology (CRCT).
www.chu-toulouse.fr

About Cell-Easy
Cell-Easy is a rapidly growing French Contract Development and Manufacturing Organization (CDMO) with a dedicated focus on advanced cell therapies. Established in 2017, Cell-Easy’s commitment extends beyond development and manufacturing; it also places a strong emphasis on regulatory and CMC aspects.
Cell-Easy offers a comprehensive range of services, from process development and process scale-up through to cGMP manufacturing of next-generation advanced cell therapies. This also includes the development of analytical tests to qualify cell therapies such as ASCs, CAR-T or CAR-NK cells, iPSCs and macrophages. Cell-Easy has demonstrated its ability to support biotech/pharmaceutical companies in advancing their programs up until phase 2, and to partner with top 30 international pharmaceutical multinationals. Thanks to its flexibility and tailored CDMO solutions, Cell-Easy facilitates patient access to these innovative therapies.

L’article IMPD Approval for FIH Trial in Systemic Sclerosis – Cell Easy est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.

Cell-Easy is pleased to welcome Mrs. Gisele Deblandre, formerly CSO at MaSTherCell, as Chief Scientific Officer

Cell-Easy, a specialized contract development and manufacturing organization (CDMO) in cell therapy, proudly announces the appointment of Mrs. Gisele Deblandre as the Chief Scientific Officer.

Over the years, Cell-Easy has recognized the challenges faced by biotechs in bridging the gap between early-stage projects and clinical development. While leading CDMOs emphasize their capacities, Cell-Easy identified that biotechs were seeking capabilities. As such, biotechs need a CDMO that understands their scientific vision and possesses the skills and resources to efficiently scale up processes while considering costs and timelines.

To meet this demand, Cell-Easy made substantial investments in internalizing analytical resources and assembling a top-tier scientific team. With extensive expertise in developing manufacturing processes and analytical methods for cell-based therapies, Gisele Deblandre will play a pivotal role in advancing Cell-Easy’s scientific initiatives and accelerating client projects.
Gisele Deblandre brings a distinctive background in GMP-grade cell-based product development within the field of immuno-oncology, encompassing various cell types, including iPSCs. She played a vital role in MaSTherCell’s growth, transforming it from a startup into a renowned CDMO. Previously, she served as CSO at CELLBOX and held the position of Head of Science and Technology at CATALENT Cell Therapy. She holds a Ph.D. in Molecular Cell Biology from the University of Brussels in Belgium.

Guillaume Costecalde, Co-Founder and President of Cell-Easy, expressed his excitement, stating, “We are delighted to have Mrs. Gisele Deblandre on board as part of our leadership team. Cell-Easy’s goal is to become the top choice as a CDMO partner for biotech and pharma firms seeking a streamlined transition from proof of concept to clinical success. Our firm focus on scientific excellence in cell development and GMP production is essential for achieving a swift transition to ‘first in human’ trials while maintaining cost-efficiency and adherence to timelines. Gisele’s expertise in immuno-oncology further strengthens our commitment to delivering on this promise to all our partners.”

This appointment marks a significant milestone for Cell-Easy, underscoring its commitment to excellence and innovation in cell-based therapies. The company eagerly anticipates continued collaboration and achievements in the future.

“We are delighted to have Mrs. Gisele Deblandre on board as part of our leadership team. Cell-Easy’s goal is to become the top choice as a CDMO partner for biotech and pharma firms seeking a streamlined transition from proof of concept to clinical success. Our firm focus on scientific excellence in cell development and GMP production is essential for achieving a swift transition to ‘first in human’ trials while maintaining cost-efficiency and adherence to timelines. Gisele’s expertise in immuno-oncology further strengthens our commitment to delivering on this promise to all our partners.” Guillaume Costecalde, Co-Founder and President of Cell-Easy

“I’m enthusiastic about joining Cell-Easy, as our shared vision extends beyond mere service provision; we aim to be genuine partners to early-stage biotechs and larger companies that need to scale their production. My focus is on enhancing Cell-Easy’s service portfolio and reinforcing our customer-centric approach. Offering scientific guidance to biotechs, efficiently scaling their processes while respecting their timelines, budgets, and procedures undoubtedly paves the way for mutual success.” Gisèle Deblandre

About Cell-Easy

Cell-Easy is a rapidly growing Contract Development and Manufacturing Services organization (CDMO) with a dedicated focus on Advanced Cell Therapies. Established in 2017, Cell-Easy’s commitment extends beyond development and manufacturing; it also places a strong emphasis on regulatory and analytical aspects.

Cell-Easy offers a comprehensive suite of services, including process development, process scale-up, cGMP manufacturing, and analytical support for immune cells (engineered CAR-T cells, NK cells, and non-engineered cells), as well as adult stem cells (MSCs, iPSCs, and Exosomes). Cell-Easy has achieved significant milestones, such as advancing programs to Phase 2 and partnering with top 30 international pharmaceutical companies, while also transitioning from autologous to allogenic processes. With tailored CDMO solutions, Cell-Easy is dedicated to efficiently bridging the gap between R&D projects and clinical development, saving both time and costs.

L’article Cell-Easy is pleased to welcome Mrs. Gisele Deblandre, formerly CSO at MaSTherCell, as Chief Scientific Officer est apparu en premier sur Cell-Easy | CDMO Expert in GMP Cell Therapy Manufacturing.