Local Manufacturing · Technology Transfer
Local CAR-T Manufacturing in Türkiye: Biruni Cell Therapy
An educational overview of how technology transfer is enabling local GMP production of an already-approved CAR-T product in Türkiye, and what this means for access, logistics and cost.
Request Free Second OpinionWhy local manufacturing matters for CAR-T
CAR-T products are living medicines. They are manufactured from a patient’s own cells, must remain viable, and are subject to strict quality and time constraints. When the manufacturing site is far from the patient, logistics become complex: cold-chain shipping, customs, longer vein-to-vein times, and higher overall cost.
Local manufacturing under a technology-transfer model aims to keep the scientific and quality standards of an already-developed product while placing production closer to the patient. This can improve operational control, reduce transport risk, and support more competitive pricing compared with fully imported Western commercial products.
What is Biruni Cell Therapy (BCT)?
Biruni Cell Therapy is a specialized laboratory established to perform local Good Manufacturing Practice (GMP) production of advanced therapy medicinal products, with a primary focus on CAR-T cell therapy.
Through a technology-transfer agreement with Curocell Inc. (South Korea), BCT is setting up the capability to manufacture Anbal-cel (anbalcabtagene autoleucel, also known in its origin market as RIMQARTO®). Anbal-cel is a CD19-directed autologous CAR-T product that incorporates dual PD-1 and TIGIT downregulation (OVIS™ platform) and received regulatory approval from the Korean Ministry of Food and Drug Safety (MFDS) in 2026 for certain relapsed/refractory large B-cell lymphomas.
This pathway is notable because it brings an already-approved product into local production rather than starting a completely new product development program from early clinical stages.
Technology transfer: what it means in practice
What is transferred
- • Manufacturing process knowledge and documentation
- • Vector and construct design (CAR + dual shRNA cassette)
- • Quality-control methods and release criteria
- • Analytical assays (identity, potency, genetic dose, safety)
- • Training and operational know-how
What remains local
- • Patient cell collection (leukapheresis)
- • Day-to-day manufacturing execution under GMP
- • In-process monitoring and final product release testing
- • Coordination with the treating clinical center
- • Regulatory pathway under Turkish authorities (TİTCK)
The goal of technology transfer is not to reinvent the product, but to reproduce it under controlled local conditions so that patients can receive a product that has already undergone clinical evaluation and regulatory review in its origin country.
Overview of the manufacturing process
A typical autologous CAR-T manufacturing pathway follows these high-level stages. Exact timing and parameters depend on the validated process and the individual patient’s cells.
Collection (Leukapheresis)
The patient’s T cells are collected at a qualified clinical site. The starting material is transferred under controlled conditions to the manufacturing laboratory.
Activation & Genetic Engineering
T cells are activated and transduced with a replication-incompetent lentiviral vector that delivers both the anti-CD19 CAR and the dual PD-1/TIGIT knockdown (OVIS™) cassette.
Expansion & Monitoring
Engineered cells are expanded in a closed or controlled culture system. Process monitoring (including metabolic parameters) supports decisions about when the culture is ready for harvest.
Quality Control & Release
Multiple orthogonal tests are performed before the product can be released: cell identity and CAR expression (flow cytometry), vector copy number, functional potency (e.g. antigen-specific cytokine release), verification of checkpoint knockdown, sterility, mycoplasma, endotoxin and other safety assays.
Infusion
After lymphodepleting chemotherapy, the release-tested product is infused at a specialized clinical center. Patients are monitored closely for cytokine release syndrome, neurologic events and other expected toxicities.
Public descriptions of the BCT process indicate a target vein-to-vein interval in the range of approximately 18–25 days once the local process is fully operational, supported by rapid release testing methods. Actual times can vary.
Quality control philosophy
For a gene-modified cellular product, quality is demonstrated by several independent lines of evidence rather than a single test. A robust release package typically includes:
Confirmation that the product consists of T cells expressing the CAR, with characterization of relevant subsets.
Measurement of vector copy number (how many copies of the therapeutic cassette are integrated per cell on average).
Evidence that the cells respond to the target antigen (for example by releasing IFN-γ) and that the intended checkpoint knockdown is achieved.
Sterility, mycoplasma, endotoxin, residual process impurities, and strategies to control the risk of replication-competent lentivirus.
Clinical administration
Manufacturing is only one part of the pathway. The clinical side — patient selection, apheresis, lymphodepletion, infusion, toxicity management and long-term follow-up — must be performed at a center with appropriate expertise and infrastructure.
In the BCT technology-transfer model, clinical administration is planned at specialized hospital settings that have the necessary capabilities for cellular therapy. Patients and referring physicians should confirm current operational status, regulatory authorization and eligibility criteria directly with the treating center.
How this differs from other approaches
| Approach | Characteristics |
|---|---|
| Full import of Western commercial product | Highest maturity of clinical data in some products, but high cost and complex cross-border logistics for a living product. |
| Technology transfer of an approved product (BCT / Anbal-cel model) | Local production of a product that already has regulatory approval and published clinical data in its origin country. Aims to improve cost and logistics while retaining the origin evidence base. |
| Domestic early-stage development (e.g. research / early clinical programs) | Important for long-term national capability, but typically still in research or early clinical stages without a finished approved commercial product. |
How can I access treatment from BCT?
Manufacturing alone does not equal treatment. Access to a BCT-manufactured CAR-T product requires a complete clinical pathway: medical evaluation, confirmation of eligibility, cell collection, manufacturing, lymphodepletion, infusion and post-infusion monitoring.
Biruni University Hospital – Current Clinical Access Point
Biruni University Hospital (Istanbul) is currently the health institution with established access to the BCT CAR-T manufacturing pathway. It is a university hospital with experience in complex hematology/oncology care and is the clinical site where patient evaluation, apheresis coordination, conditioning, infusion and specialized monitoring for this technology-transfer product are organized.
In practical terms, patients who may be candidates are typically referred for multidisciplinary review at Biruni University Hospital. The hospital team assesses diagnosis, prior treatments, disease status, organ function and other eligibility factors before any decision about leukapheresis and manufacturing can be made.
As of the latest available information, Biruni University Hospital is the only clinical center with active access to BCT-manufactured Anbal-cel under the technology-transfer framework. This status can evolve; patients and physicians should always confirm the current situation directly with the hospital.
Typical access steps
- Initial medical information review (diagnosis, treatment history, current status)
- Multidisciplinary evaluation at the clinical center (Biruni University Hospital)
- Confirmation of eligibility and practical readiness (performance status, organ function, infection screening, etc.)
- Leukapheresis (cell collection)
- Local manufacturing at BCT and quality release
- Lymphodepletion, infusion and inpatient monitoring at the hospital
- Structured follow-up
Because CAR-T therapy is highly specialized, self-referral without complete medical documentation is rarely sufficient. The most efficient route is usually through a treating hematologist/oncologist who can share the necessary clinical information, or via a structured second-opinion / eligibility review process.
Educational second-opinion option: This portal offers a free medical second-opinion request form. You can submit key clinical details for an initial educational review that helps clarify whether formal evaluation at the clinical center may be appropriate.
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