Preclinical vs GMP 2017-09-06T16:37:40+00:00

To allow for a seamless transition from preclinical development to the clinical stage, we offer both preclinical and GMP cytokines. Both product grades are produced under the same conditions in a GMP facility, using identical production steps and expression systems. This ensures an equal product quality and performance.

The difference between both quality levels is that we offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products. Our preclinical grade products therefore offer a cost efficient alternative for the early development phase when safety and quality of raw materials have a lower priority.

Preclinical grade: Intended for preclinical ex vivo use
GMP grade: Intended for ex vivo use in clinical trials and commercial ATMP manufacturing

Overview Preclinical vs. GMP Cytokines:

Quality AttributesPreclinical gradeGMP grade
MCB/WCB fully characterizednoyes
All processes according to released SOPsyesyes
Batch documentationyesyes
Change control, OOS and deviation proceduresyes*yes
Production and QC equipment qualifiednoyes
Cleaning validation for production equipmentyes*yes
Process validation by 3 consistency batchesnoyes
Validation of all analytical methodsnoyes
Determination of DNA contentnoyes
Sterility testingyesPh. Eur.
Purity≥ 95%≥ 97%
Endotoxin testing (all cytokines except IL-2, IL-7, IL-15 and IL-21)< 1000 EU/mg≤ 50 EU/mg
Endotoxin testing (IL-2, IL-7, IL-15 and IL-21)< 25 EU/mg≤ 25 EU/mg
Expiry date on CoAyesyes
Validation of shelf life by accelerated and real time testingno**yes
Identity of product confirmedone method≥ two methods
Supplier and raw material controlnoyes
Activity value on CoAminimumspecific
Determination of host cell proteinnoyes
Regulatory support: DMF, on-site audits, change notifications, etc.noyes

* All measures are applied for our preclinical grade production batches. We however don’t send change notifications for our preclinical grade cytokines and these quality attributes cannot be verified in an audit.

**Shelf life is determined according to data generated through stress tests in which the impurity profile is analyzed under forced degradation conditions.

Preclinical grade: Intended for preclinical ex vivo use
GMP grade: Intended for ex vivo use in clinical trials and commercial ATMP manufacturing

Overview Preclinical vs. GMP Cytokines:

Quality AttributesPreclinical grade
MCB/WCB fully characterizedno
All processes according to released SOPsyes
Batch documentationyes
Change control, OOS and deviation proceduresyes*
Production and QC equipment qualifiedno
Cleaning validation for production equipmentyes*
Process validation by 3 consistency batchesno
Validation of all analytical methodsno
Determination of DNA contentno
Sterility testingyes
Purity≥ 95%
Endotoxin testing (all cytokines except IL-2, IL-7, IL-15 and IL-21)< 1000 EU/mg
Endotoxin testing (IL-2, IL-7, IL-15 and IL-21)< 25 EU/mg
Expiry date on CoAyes
Validation of shelf life by accelerated and real time testingno**
Identity of product confirmedone method
Supplier and raw material controlno
Activity value on CoAminimum
Determination of host cell proteinno
Regulatory support: DMF, on-site audits, change notifications, etc.no
Quality AttributesGMP grade
MCB/WCB fully characterizedyes
All processes according to released SOPsyes
Batch documentationyes
Change control, OOS and deviation proceduresyes
Production and QC equipment qualifiedyes
Cleaning validation for production equipmentyes
Process validation by 3 consistency batchesyes
Validation of all analytical methodsyes
Determination of DNA contentyes
Sterility testingPh. Eur.
Purity≥ 97%
Endotoxin testing (all cytokines except IL-2, IL-7, IL-15 and IL-21)≤ 50 EU/mg
Endotoxin testing (IL-2, IL-7, IL-15 and IL-21)< 25 EU/mg
Expiry date on CoAyes
Validation of shelf life by accelerated and real time testingyes
Identity of product confirmed≥ two methods
Supplier and raw material controlyes
Activity value on CoAspecific
Determination of host cell proteinyes
Regulatory support: DMF, on-site audits, change notifications, etc.yes

* All measures are applied for our preclinical grade production batches. We however don’t send change notifications for our preclinical grade cytokines and these quality attributes cannot be verified in an audit.

**Shelf life is determined according to data generated through stress tests in which the impurity profile is analyzed under forced degradation conditions.

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