최근 임상 시험의 증가로 safety, purity, stability가 검증된 재조합 단백질 제품에 대한 수요가 증가하고 있습니다. Proteintech의 HumanKine® 단백질은 xeno-free, animal component-free일 뿐만 아니라 ISO13485 인증을 받았으며, GMP를 준수하여 생산하므로 임상 응용에 이상적입니다.
“For Humans… By Human Cells”
HumanKine HEK293-expressed human proteins
- Animal component free
- Tag, xeno and endotoxin free
- Authentic human proteins
- Native human folding & glycosylation
- High purity & activity
- Manufactured in the USA
cGMP Grade Cytokines & Growth Factors
Proteintech is ISO13485 certified and our cGMP Policy ensures:
- ISO13485 certified
- Regulatory compliance: USP <1043>, Ph. Eur. 5.2.12, WHO TRS, No. 882, 1992 Annex 1
- Quality check at every step of production
- ISO rated clean rooms for manufacturing and filling
- Animal component free and Xeno free production process
- Regulatory support and Facilitiy available for on site audit
Documents for cGMP grade proteins
Documents available on request
- Certificate of Analysis (COA)
- Certificate of origin (COO)
- Sterility certificate
- BSE/TSE statement
- Viral testing certificate for Master cell bank
- Drug Master Files- filing in progress.
Proteintech is ISO 13485:2016 certified and our GMP HumanKine products are manufactured and tested in accordance with the relevant sections of the following standards:
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
- Sterility testing according to USP <71>.
- Mycoplasma testing according to USP<63>.
- Bacterial endotoxin test according to USP<85>.
To facilitate a seamless preclinical to clinical transition, we offer both RUO and GMP grade cytokines and growth factors. Both product grades are produced under the same conditions in a GMP facility, using identical production processes. The GMP grade products come with extensive documentation, as well as thorough QC testing and traceability, whereas our line of RUO grade products are more cost-effective during early research and development.
Quality Features |
RUO |
GMP |
|---|---|---|
| Quality Management System: Manufactured, tested, released & distributed under ISO 13485 | ✔ | ✔ |
| Adherence to GMP guidelines | ✘ | ✔ |
| Master cell bank fully characterized | ✔ | ✔ |
| All processes according to released SOPs | ✔ | ✔ |
| Batch documentation | ✔ | ✔ |
| Change control, OOS and deviation procedures | ✔ | ✔ |
| Production and QC equipment qualified | ✔ | ✔ |
| Process validation by 3 consistency batches | ✘ | ✔ |
| Purity | > 95% | > 95% |
| Sterility testing USP<71> | ✘ | ✔ |
| Mycoplasma testing USP<63> | ✘ | ✔ |
| Endotoxin testing USP<85> | < 1.0 EU/µg | < 0.1 EU/µg |
| Validation of shelf life by accelerated and real-time testing | ✔ | ✔ |
| Identity of product confirmed | Two methods | Two methods |
| Supplier and raw material control | ✔ | ✔ |
| Activity value on CoA | EC50 | EC50 and specific activity (if NIBSC standard available) |
| Regulatory support: DMF, on-site audits, change notifications, quality agreements etc. | ✘ | ✔ (In progress) |
Driven by the desire for improved product consistency and safety of our products, we follow a strict Animal component-free (ACF) and Xeno-free policy. This policy ensures:
- The final product does not contain any constituent that is either an animal tissue, body fluid or components derived from it.
- All the materials, from procurement to final products, are stored and handled in a dedicated animal-free facility.
- The final product do not contain materials from non- human animal sources or recombinant materials made from non-human animal sources.
Q. How are HumanKine GMP cytokines different from the RUO cytokines?
A. GMP proteins come with extensive documentation for traceability, as well as additional quality control testing and quality assurance reviews, whereas the RUO grade line offers reliable products which are more cost-effective during early research and development. As the manufacturing process is the same for RUO and GMP products, HumanKine offers a seamless preclinical-to-clinical transition line of products, saving a significant amount of time and money.
Q. Are HumanKine GMP cytokines suitable for direct human administration?
A. No, HumanKine GMP products are not intended to use as an excipient or therapeutic product that can be directly administered to the human body. These products are developed to be used as raw materials for the manufacturing of cell and gene therapy products, but not as part of the final formulation or therapy.
Q. Is HumanKine GMP product manufacturing certified by FDA or other regulatory agencies?
A. US-FDA does not audit or certify manufacturing facilities that produce ancillary materials. HumanKine GMP products are manufactured under the ISO13485 quality management system adhering to USP and European pharmacopeia recommendations to ensure potency, purity, and safety. The manufacturing facility can be audited by the end users upon request.
Q. What is the risk classification for HumanKine GMP Cytokines?
A. HumanKine GMP Cytokines are classified as Tier 2 risk products under USP Chapter <1043>. The products are low-risk, well-characterized materials, produced in compliance with GMP guidelines, and intended to be used as ancillary materials/raw materials.
Q. Are HumanKine GMP cytokines animal component free?
A. Yes! HumanKine GMP manufacturing processes and the final product do not use or contain any animal or human-derived components.
Q. How are HumanKine GMP cytokines shipped?
A. HumanKine GMP products are shipped as lyophilized, in glass vials at ambient temperature. The stability of these products is extensively tested to ensure the above-specified shipping conditions do not affect product quality or performance.
