GaiaCell advanced cell & gene therapy

GaiaCell: Your Partner in Personalized Cell Therapies

At GaiaCell, we’re dedicated to revolutionizing healthcare through personalized cell products and services spanning orthopaedics, hemato-oncology, pulmonology, immunity, and beyond. Our state-of-the-art laboratory, boasting an EU GMP certificate, ensures the highest quality standards, adhering closely to EU recommendations and legal mandates.

Our commitment extends beyond current therapies. With a dynamic research and development team, led by seasoned experts, we’re at the forefront of innovation, forging new pathways in cell therapy and product development through global collaboration.

Additionally, GaiaCell proudly offers contract development and manufacturing services (CDMO), providing tailored solutions to meet diverse needs.

Products and Technologies

CELL THERAPIES

Cell therapies, particularly those harnessing mesenchymal stromal/stem cells (MSCs), represent a groundbreaking approach in healthcare. Unlike traditional methods focused solely on symptom management and disease progression mitigation, these therapies tap into the body’s innate regenerative abilities, offering the potential for disease eradication.

apeutic potential. Initially recognized for their ability to differentiate into various cell types, MSCs’ immunomodulatory and trophic properties have since broadened their application scope to include the treatment of diverse immune-mediated conditions.

MSCs, with their multipotent nature, have emerged as key players in regenerative medicine. Their remarkable capacity to restore balance in inflamed, injured, or diseased tissues has sparked extensive research into their ther-

Therapeutic fields:

This paradigm shift from symptomatic relief to disease resolution underscores the transformative power of cell therapies, paving the way for a future where chronic illnesses may be conquered through the body’s own healing mechanisms.

GASTROENTEROLOGY

CHRONIC WOUNDS

VASCULAR DISEASES

MAXILLOFACIAL AND ORAL SURGERY

AESTHETIC PROCEDURES

CDMO

GaiaCell: Your Trusted Partner in Cell-Based Therapeutics

As a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell-based therapeutics, GaiaCell brings extensive expertise to the forefront of healthcare innovation. Drawing from the success of our proprietary products, which have demonstrated efficacy in clinical settings, we leverage invaluable knowledge and experience to propel future endeavours.

Moreover, our laboratory is registered for work with GMO biosafety level 2, underscoring our commitment to safety and regulatory compliance at every stage of development.

Collaborating closely with strategic partners, we’re at the forefront of pioneering advancements in point-of-care networks, as well as the development of cutting-edge cell- and genebased therapeutics. Our collaborative efforts extend to the forefront of cancer immunotherapy, where we’re dedicated to driving transformative outcomes.

Partner with GaiaCell and embark on a journey of innovation, excellence, and transformative impact in healthcare.

At our facilities, equipped with Class B clean rooms featuring laminar airflow hoods (Class A), we execute critical manufacturing processes with precision and adherence to the highest quality standards. Throughout production, stringent quality control measures ensure compliance with guidelines outlined in the European Pharmacopoeia, guaranteeing the integrity of intermediate and final cell products.

GMP

GaiaCell Facility Highlights:

• 75 m2 Cleanroom Area: Dedicated to providing cGMP manufacturing services, ensuring adherence to stringent quality standards.

• Two Class B Clean Rooms: Equipped with four Class A safety cabinets, facilitating precise and controlled manufacturing processes.

• Class D Clean Room: Featuring four bioreactors as closed process systems, enabling efficient and sterile production.

• Separate Corridors: Ensuring distinct pathways for personnel and materials, optimizing workflow efficiency and safety protocols.

• Regular Microbiological and Environmental Controls: Implemented to maintain a clean and sterile environment conducive to manufacturing excellence.

• Particle Control: Ongoing monitoring of particles in Class A and B areas, ensuring product integrity and compliance with regulatory standards.

• Temperature, Humidity, and Air Pressure Control: Continuous oversight to maintain optimal conditions for production and storage.

• Quality Control: Rigorous assessment of intermediate and final cell products, conducted in accordance with established guidelines and European Pharmacopoeia standards.

• Storage Capacity: Comprehensive facilities for the controlled storage of raw materials, intermediate, and final cell products, spanning refrigerated, ultra-low, and cryopreservation temperatures.

At GaiaCell, we prioritize excellence in manufacturing and quality assurance, leveraging advanced infrastructure and meticulous protocols to deliver exceptional cell-based therapeutics.

POC

GaiaCell: Advancing Point-of-Care Solutions in ATMP Manufacturing

In the realm of Advanced Therapy Medical Products (ATMPs), accessibility and timeliness are paramount. However, the short shelf life and stability challenges associated with ATMPs, often lasting less than three days, pose significant logistical hurdles for patients and hospitals alike.

Recognizing these constraints, GaiaCell is committed to pioneering solutions that bridge the gap between ATMP manufacturing and patient care. Our focus lies in the establishment of Point-ofCare (POC) laboratories situated near hospital environments.

By adhering to Good Manufacturing Practice (GMP) guidelines, our POC laboratories enable the timely and efficient production of ATMPs, empowering hospitals to offer cutting-edge therapies with minimal delay. This proximity not only streamlines logistical and administrative processes but also enhances patient accessibility to life-changing treatments.

At GaiaCell, we’re dedicated to driving innovation in ATMP manufacturing, ensuring that advanced therapies reach those in need when they need them the most.

R&D

GaiaCell Research and Development Laboratory: Driving Innovation in Cell Therapies

Our Research and Development Laboratory stands at the forefront of cellular innovation, comprising three interconnected facilities dedicated to advancing the frontier of medical science.

genetically modified organisms at biosafety level 2, ensuring meticulous attention to risk mitigation and containment protocols.

In the first segment, our skilled team conducts meticulous work on cell cultures, encompassing vital processes such as isolation, cultivation, and cell manipulation. Here, we leverage cutting-edge techniques to optimize cell viability and functionality, laying the groundwork for groundbreaking therapies.

At GaiaCell, we’re driven by a passion for innovation and a commitment to transforming the landscape of cellular medicine, one breakthrough at a time.

Moving seamlessly into the second and third sections, our focus shifts to analytical methodologies critical for understanding cellular behaviour and therapeutic efficacy. Leveraging molecular-biology methods, biochemical assays, and state-of-the-art flow cytometry analysis, we unravel the complexities of cellular function, paving the way for precision therapies tailored to individual patient needs.

Committed to safety and regulatory compliance, our laboratory is registered to work with

CONSULTING

GaiaCell Consulting: Your Trusted Partner in Cell Therapy Solutions

With a wealth of experience accumulated over many years, GaiaCell Consulting offers expert guidance and support across a spectrum of crucial areas in the field of cell therapies. Our specialized consulting services encompass:

1. Laboratory GMP Certification: Streamlining the certification process for Advanced Therapy Medicinal Product (ATMP) manufacturing, ensuring compliance with rigorous Good Manufacturing Practice (GMP) standards.

2. GMO Biosafety Level 2 Registration: Facilitating the seamless registration of laboratories for working with genetically modified organisms, ensuring adherence to biosafety protocols at the appropriate level.

3. Authorization for Human Tissues and Cells: Navigating the complex regulatory landscape of EU legislation governing human tissues and cells for therapeutic purposes, ensuring full compliance and authorization.

4. Licensing for iATMP Clinical Trials: Guiding clients through the intricacies of obtaining licenses for investigational Advanced Therapy Medicinal Products (iATMPs), facilitating smooth progression into clinical trials.

5. Clean Room Facility Design and Maintenance: Providing comprehensive support in the design, construction, and maintenance of GMP-compliant clean room facilities, tailored to meet the specific needs of ATMP manufacturing (including clean room classes D and B).

6. Technology and Process Transfer: Facilitating the seamless transfer of technologies and processes from the research and development (R&D) phase to the GMP environment, ensuring continuity and efficiency in manufacturing operations.

At GaiaCell Consulting, we’re committed to leveraging our expertise to empower your success in the dynamic landscape of cell therapy innovation.