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 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 Attributes | Preclinical grade | GMP grade |
|---|---|---|
| Quality Management System: Manufactured, tested, released & distributed under ISO 9001:2015 | yes | yes |
| Adherence to GMP guidelines | no | yes |
| MCB/WCB fully characterized | yes* | yes |
| All processes according to released SOPs | yes | yes |
| Batch documentation | yes | yes |
| Change control, OOS and deviation procedures | yes* | yes |
| Production and QC equipment qualified | no | yes |
| Cleaning validation for production equipment | yes* | yes |
| Process validation by 3 consistency batches | no | yes |
| Validation of all analytical methods | no | yes |
| Determination of DNA content | no | yes |
| Sterility testing | yes | Ph. 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 CoA | yes | yes |
| Validation of shelf life by accelerated and real time testing | no** | yes |
| Identity of product confirmed | one method | ≥ two methods |
| Supplier and raw material control | yes* | yes |
| Activity value on CoA | minimum | specific |
| Determination of host cell protein | no | yes |
| Regulatory support: DMF, on-site audits, change notifications, quality agreements etc. | no | yes |
| Regulatory compliance: USP <1043>, Ph. Eur. 5.2.12, ISO TS 20399 | N/A | 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.
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 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.