Preclinical vs GMP

To allow for a seamless transition from preclinical development to the clinical stage, we offer both preclinical and GMP grade 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 regulatory support and quality of raw materials have a lower priority and access to GMP-relevant documentation is not required yet.

Download the complete information (Technical Note):

CellGenix® rh Cytokines - Preclinical vs GMP

Intended Use

Preclinical Grade
(produced in GMP facility*)

Intended for preclinical ex vivo use

GMP Grade

Intended for ex vivo use in clinical trials and commercial ATMP manufacturing

Quality Attributes Preclinical grade GMP grade
MCB/WCB fully characterized no yes
All processes according to released SOPs yes* yes
Access to batch documentation no yes
Change control, OOS and deviation procedures yes* yes
Validation of shelf life by accelerated and long-term testing** no yes**
Expiry date on CoA yes yes
Identity of product confirmed one method ≥ two methods
Activity value on CoA minimum specific
Regulatory support: DMF, on-site audits, change notifications, etc. no yes
Regulatory compliance

USP <1043>
Ph. Eur. 5.2.12

 USP <1043>
Ph. Eur. 5.2.12
ISO 20399:2022

*As soon as a corresponding GMP product is available, these quality attributes are true for our preclinical grade production batches. These quality attributes cannot be verified in an audit for our preclinical grade products.

**Shelf life for preclinical grade cytokines is determined according to data generated through stress tests/accelerated studies in which the impurity profile is analyzed under forced degradation conditions. Complete long-term data for GMP grade cytokines are available 3 years after product launch.

Quality Attributes Preclinical grade
MCB/WCB fully characterized no
All processes according to released SOPs yes
Batch documentation yes
Change control, OOS and deviation procedures yes*
Production and QC equipment qualified no
Cleaning validation for production equipment yes*
Process validation by 3 consistency batches no
Validation of all analytical methods no
Determination of DNA content no
Sterility testing yes
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 CoA yes
Validation of shelf life by accelerated and real time testing no**
Identity of product confirmed one method
Supplier and raw material control no
Activity value on CoA minimum
Determination of host cell protein no
Regulatory support: DMF, on-site audits, change notifications, etc. no

Quality Attributes GMP grade
MCB/WCB fully characterized yes
All processes according to released SOPs yes
Batch documentation yes
Change control, OOS and deviation procedures yes
Production and QC equipment qualified yes
Cleaning validation for production equipment yes
Process validation by 3 consistency batches yes
Validation of all analytical methods yes
Determination of DNA content yes
Sterility testing Ph. 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 CoA yes
Validation of shelf life by accelerated and real time testing yes
Identity of product confirmed ≥ two methods
Supplier and raw material control yes
Activity value on CoA specific
Determination of host cell protein yes
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.