CAR-T, mRNA and Antibody Engineering Research & Development
About Us
ACGTC's Cell and Gene Therapy (CGT) Center of Expertise provides end-to-end support for the development and commercialization of innovative cell and gene therapies. Our team of over 30 cross-functional experts seamlessly integrates regulatory, clinical, and data management capabilities to navigate the complex journey from bench to bedside.
By combining deep regulatory knowledge with operational excellence, we ensure efficient and patient-centric therapy development. Our close collaboration with patient engagement teams allows us to incorporate patient insights throughout the entire process.
ACGTC’s strategic presence across the Middle East, North Africa, Central and Eastern Europe, and Turkey positions us as a unique partner for global market expansion. We offer comprehensive services, including regulatory consulting, preclinical and clinical studies, and post-market support, to accelerate your therapy's reach to patients in need.
With our proven expertise and regional footprint, ACGTC is committed to delivering exceptional value and driving positive patient outcomes.
Our Centers
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Contact Us
~100 qualified
healthcare professionals
Access to more than
100 million
patient population
2 Centers in Turkey
Turkey CGT Centers' physical area is approx. 900m2. It consists of cell culture and research laboratories that allow to carry out studies including basic research and R&D activities on stem cell and gene therapies.
There are 12 laboratories, freezer room, microscope room, sterilization room, GMP office in the facility. In addition, there is 100m2 area allocated for operation under GMP conditions to enable the production, processing and propagation of stem cells and other cell-gene therapy products for therapeutic use.
2 Centers in Tunisia
Turkey CGT Centers' physical area is approx. 900m2. It consists of cell culture and research laboratories that allow to carry out studies including basic research and R&D activities on stem cell and gene therapies.
There are 12 laboratories, freezer room, microscope room, sterilization room, GMP office in the facility. In addition, there is 100m2 area allocated for operation under GMP conditions to enable the production, processing and propagation of stem cells and other cell-gene therapy products for therapeutic use.
3 Centers
in Saudi Arabia
Turkey CGT Centers' physical area is approx. 900m2. It consists of cell culture and research laboratories that allow to carry out studies including basic research and R&D activities on stem cell and gene therapies.
There are 12 laboratories, freezer room, microscope room, sterilization room, GMP office in the facility. In addition, there is 100m2 area allocated for operation under GMP conditions to enable the production, processing and propagation of stem cells and other cell-gene therapy products for therapeutic use.
ACGTC Capabilities
Our Services
Advantages of our Immunotherapy Centers
Novel Approach
Our centers aim to explore a relatively untapped area within the mRNA field. This innovative approach has the potential to revolutionize treatment options for conditions such as heart disease, diabetes, and obesity.
Interdisciplinary Collaboration
Bringing together researchers from various fields with complementary skills and expertise allows to tackle complex diseases like those affecting the cardiovascular and metabolic systems. By fostering collaboration, our Centers can leverage diverse perspectives and techniques to accelerate progress in mRNA therapy development.
Expertise and Experience
Cell & Gene Therapy Centers have multidisciplinary teams of healthcare professionals with specialized expertise in cellular therapy, including oncologists, hematologists, immunologists, and cell processing experts.
Clinical Operations
Our project management expertise is rooted in uniform processes, fully compliant with international regulatory standards. We ensure meticulous oversight frominitiation to project closure, tracking performance against established schedules and closely monitoring project expenditures to maintain alignment with the agreed-upon financial plans.
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Clinical Development Program Management
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Flexible Clinical Monitoring Solutions
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Resource Optimization
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Efficient Study Start-up Initiation
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Patient and Site Engagement
Regulatory Affairs
Leveraging our in-depth knowledge of FDA, EMA, and other global regulatory bodies, we provide strategic and practical assistance to accelerate the development of pharmaceutical products and medical devices. This support spans the full spectrum of the product lifecycle, ensuring a streamlined and efficient process.
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Regulatory Intelligence & Operational Expertise
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Strategic and Operational Regulatory Support
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Global Regulatory Consulting and Advisory
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Product Lifecycle Management
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Regulatory Documentation and Submissions
Drug Safety & Data Management
Our safety reporting system, equipped with automated, customizable inputs, offers advanced reporting capabilities and comprehensive dashboard information. This setup enhances transparency, enabling efficient monitoring and management of drug safety throughout its lifecycle. We integrate all safety and data management services, ensuring high-quality, efficient delivery with clear, easily interpretable outputs.
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Established Safety Reporting System
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Standardization of Clinical Data
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Construction of Databases
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Pharmacovigilance Solutions
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Uniform Data Structuring
Medical Writing
With comprehensive medical writing services, ranging from creating single documents to managing extensive writing projects, our skilled medical writers possess deep therapeutic knowledge and experience to ensure high-quality content tailored to your needs. Our expertise covers a broad spectrum of therapeutic areas such as Oncology, CNS,Metabolic Diseases, Cardiovascular, Infectious Diseases, and more.
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CERs and CEPs (Clinical Evaluation Reports and Plans)
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Clinical Research Literature Reviews
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User Documentation and Labeling
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Summaries of Safety and Clinical Performance (SSCPs)
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Implant Cards
Project & Trial Management
We are well-versed in the complexities of modern clinical trials. Our established project delivery methods enable sponsors to confidently navigate these challenges, yielding significant improvements in timelines, cost efficiency, and risk management. Our strategy focuses on boosting efficiency, simplifying procedures, and enhancing overall
project success.
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Customized employee training and development
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Advanced technologies and immediate data analysis
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Perpetual enhancement of operational processes
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Adaptive governance structures
Biostatistics
Our array of support services in biostatistics offers cost-efficient strategies that significantly enhance your research and development pipeline. Leveraging our expertise in the field, we emphasize the use of standardized, validated statistical methodologies, backed by an in-depth quality control system to ensure a precise and timely analysis.
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Customized employee training and development
-
Advanced technologies and immediate data analysis
-
Perpetual enhancement of operational processes
-
Adaptive governance structures
Clinical Operations
-
Clinical Development Program Management
-
Flexible Clinical Monitoring Solutions
-
Resource Optimization
-
Efficient Study Start-up Initiation
-
Patient and Site Engagement
Clinical Operations
Our project management expertise is rooted in uniform processes, fully compliant with international regulatory standards. We ensure meticulous oversight frominitiation to project closure, tracking performance against established schedules and closely monitoring project expenditures to maintain alignment with the agreed-upon financial plans.
Regulatory Affairs
-
Regulatory Intelligence & Operational Expertise
-
Strategic and Operational Regulatory Support
-
Global Regulatory Consulting and Advisory
-
Product Lifecycle Management
-
Regulatory Documentation and Submissions
Regulatory Affairs
Leveraging our in-depth knowledge of FDA, EMA, and other global regulatory bodies, we provide strategic and practical assistance to accelerate the development of pharmaceutical products and medical devices. This support spans the full spectrum of the product lifecycle, ensuring a streamlined and efficient process.
Drug Safety & Data Management
-
Established Safety Reporting System
-
Standardization of Clinical Data
-
Construction of Databases
-
Pharmacovigilance Solutions
-
Uniform Data Structuring
Drug Safety &
Data Management
Our safety reporting system, equipped with automated, customizable inputs, offers advanced reporting capabilities and comprehensive dashboard information. This setup enhances transparency, enabling efficient monitoring and management of drug safety throughout its lifecycle. We integrate all safety and data management services, ensuring high-quality, efficient delivery with clear, easily interpretable outputs.
Medical Writing
-
CERs and CEPs (Clinical Evaluation Reports and Plans)
-
Clinical Research Literature Reviews
-
User Documentation and Labeling
-
Summaries of Safety and Clinical Performance (SSCPs)
-
Implant Cards
Medical Writing
With comprehensive medical writing services, ranging from creating single documents to managing extensive writing projects, our skilled medical writers possess deep therapeutic knowledge and experience to ensure high-quality content tailored to your needs. Our expertise covers a broad spectrum of therapeutic areas such as Oncology, CNS,Metabolic Diseases, Cardiovascular, Infectious Diseases, and more.
Project & Trial Management
-
Customized employee training and development
-
Advanced technologies and immediate data analysis
-
Perpetual enhancement of operational processes
-
Adaptive governance structures
Project & Trial Management
We are well-versed in the complexities of modern clinical trials. Our established project delivery methods enable sponsors to confidently navigate these challenges, yielding significant improvements in timelines, cost efficiency, and risk management. Our strategy focuses on boosting efficiency, simplifying procedures, and enhancing overall
project success.
Biostatistics
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Statistical Analysis Plan development
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Analysis and reporting including ISS/ISE
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SafetyEvent Identifications and Endpoint
Adjudications support -
Interim-Analysis and Safety Update
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PK/PD Analysis
Biostatistics
Our array of support services in biostatistics offers cost-efficient strategies that significantly enhance your research and development pipeline. Leveraging our expertise in the field, we emphasize the use of standardized, validated statistical methodologies, backed by an in-depth quality control system to ensure a precise and timely analysis.
2 Centers in Turkey
Turkey CGT Centers' physical area is approx. 900m2. It consists of cell culture and research laboratories that allow to carry out studies including basic research and R&D activities on stem cell and gene therapies.
There are 12 laboratories, freezer room, microscope room, sterilization room, GMP office in the facility. In addition, there is 100m2 area allocated for operation under GMP conditions to enable the production, processing and propagation of stem cells and other cell-gene therapy products for therapeutic use.
2 Centers in Tunisia
Tunis CGT Center includes a university hospital and a blood transfusion center. A university hospital includes administration, technical services, outpatient consultations, a day hospital and laboratory services
A blood transfusion center is a multidisciplinary service which is equipped with a structure which ensures the clinical part and the research part at the same time in all that relates to hemovigilance, immunotherapy, phenotyping and
the research of diseases on the basis of advanced molecular and
genetic techniques.
3 Centers
in Saudi Arabia
Saudi Arabia CGT Centers are one of the leading Research Centers in the KSA. Multiple research projects performed by Riyadh CGT Center lead to incredible advances in Saudi Arabia’s most common diseases including diabetes, cardiovascular diseases, trauma, obesity, and hypertension.
Riyadh CGT Center is Biomedical Basic, Translational and Clinical Research institute, that focuses on transforming lab results into products that improve the quality of life, while training skillful researchers within the healthcare community.
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