Health Library · Turkey, Quality & Local Manufacturing
Does Local Manufacturing Mean Lower Quality? Facts About GMP Standards
Educational article · Updated 2026
A frequent concern when advanced therapies are produced outside the United States or Western Europe is quality. Many people assume that “local” automatically means “lower standard.” For CAR-T cell therapy, that assumption does not hold if the manufacturing follows proper Good Manufacturing Practice (GMP) requirements.
Quality in cellular therapy is defined by the process, the controls, the testing and the quality system — not by the country name on the facility door. This article explains what GMP actually requires and how local manufacturing can meet the same fundamental expectations used internationally.
What GMP means for CAR-T products
Good Manufacturing Practice is a set of principles and requirements that ensure medicinal products are consistently produced and controlled according to quality standards appropriate for their intended use. For advanced therapy medicinal products such as CAR-T, GMP covers the entire chain from starting materials to the released final product.
Key elements typically include:
- Qualified cleanroom facilities with controlled air quality and environmental monitoring
- Documented, validated manufacturing processes
- Trained and qualified personnel
- In-process controls and clear decision points
- Comprehensive release testing before the product is given to a patient
- Traceability, deviation management and change control
- A functioning quality management system with independent quality oversight
These requirements exist whether the laboratory is located in the United States, Europe, Korea or Türkiye. A facility that meets them can produce a high-quality product; a facility that does not cannot be rescued by geography alone.
What is actually tested before a CAR-T product is released
Before an autologous CAR-T product can be infused, laboratories perform a battery of tests. While exact panels vary by product, they commonly address:
- Identity and phenotype — confirmation that the cells are the intended type and express the chimeric antigen receptor
- Viability and dose — that enough living cells are present
- Genetic characteristics — such as vector copy number
- Potency / function — evidence that the cells respond to the target antigen
- Safety — sterility, mycoplasma, endotoxin and other impurity or adventitious-agent controls
- Additional product-specific attributes — for example confirmation of intended functional modifications such as checkpoint knockdown
The product is released only when these predetermined specifications are met. This release philosophy is the same in principle for a transferred approved product manufactured locally and for a commercial product manufactured in a long-established Western facility.
Why “local” is not the same as “uncontrolled”
The word “local” only describes geography. It does not describe the quality system. Two very different situations can both be called local manufacturing:
- Early research or poorly controlled production — limited process definition, incomplete testing, insufficient documentation. This is genuinely higher risk.
- GMP manufacturing under a technology-transfer model — a defined process taken from an already-developed product, validated at the new site, operated under cleanroom controls, and released against formal specifications. This is designed to meet established quality expectations.
Conflating the two creates unnecessary fear. The relevant questions are about process control, testing and oversight — not about the passport of the manufacturing site.
Example: technology transfer in Türkiye
When a laboratory receives a technology transfer of an already-approved CAR-T product, it inherits process knowledge, analytical methods and release criteria that have already been refined through prior development and regulatory review. Local validation and training are still required, but the starting point is far more mature than inventing a process from early laboratory research.
One concrete illustration in Türkiye is the pathway linked to Biruni Cell Therapy (BCT). BCT is establishing local GMP manufacturing of Anbal-cel (anbalcabtagene autoleucel) through technology transfer from Curocell (South Korea). Anbal-cel is a CD19-directed CAR-T product that already received regulatory approval from the Korean Ministry of Food and Drug Safety (MFDS) in 2026, supported by published clinical data.
In this model, the intention is to reproduce the origin manufacturing and quality approach under local GMP conditions, rather than building an entirely new experimental product from early research stages. Clinical administration for this pathway is currently organized through specialized hospital settings with access to the BCT manufacturing route. As with any advanced therapy, final eligibility and operational status must be confirmed with the treating clinical team.
Common misconceptions
“If it is cheaper, quality must be lower.”
Cost is influenced by labor, facilities, logistics, scale and commercial structure. A lower price does not automatically mean weaker release specifications.
“Only US or EU sites can be trusted.”
High-quality manufacturing exists in multiple regions. What matters is whether the site operates under appropriate GMP standards and whether the product has a transparent evidence and quality package.
“Local production is experimental by definition.”
Manufacturing an already-characterized product under transferred and validated methods is operationally different from running a first-in-human experimental construct.
“GMP is just paperwork.”
Documentation is essential, but GMP also includes physical controls (cleanrooms, environmental monitoring), process validation, trained staff and real testing of the product before release.
What patients and physicians should look for
Regardless of country, useful questions include:
- Is manufacturing performed under GMP conditions?
- Is the product based on a construct and process with existing clinical data and regulatory history?
- What release tests are performed before infusion?
- How is process validation and comparability addressed at the local site?
- Which clinical center will manage collection, infusion and toxicity monitoring?
- Is there clear medical and quality accountability for the pathway?
These questions are more informative than asking only “Where is it made?”
Bottom line
Local manufacturing does not mean lower quality by definition. Quality is determined by whether the product is made under controlled GMP conditions, tested against meaningful specifications, and supported by appropriate clinical and operational infrastructure.
When those elements are present — especially in a technology-transfer model built on an already-approved product — local production can meet the same fundamental quality expectations that patients and physicians should demand anywhere in the world.
Geography is secondary. Process control, testing and clinical readiness are primary.