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.
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|
Ph. Eur. 5.2.12
*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.
* 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.