The growing demand for high-quality biological materials continues to drive advancements in disease research and therapeutic development. Our recombinant cytokine and growth factors portfolio leverages our deep expertise to support life science, biotechnology, and pharmaceutical companies in discovering new biological insights and developing innovative cell and gene therapies. With end-to-end in-house production control, our cytokines and growth factors are recognized for their exceptional quality, batch-to-batch consistency, and reliability—enabling seamless transitions from research applications to cGMP compliance.
We offer a complete cytokine solution spanning basic research to clinical production, featuring three distinct grades—Research Grade, Premium Grade (Pre-GMP), and GMP Grade—each designed to address specific needs across different R&D stages.
Research Grade is designed for academic and scientific research institutions, focusing on improving experimental reproducibility. Through stringent quality control, ultra-low endotoxin levels, and animal-origin-free (AOF) production processes, it ensures reliability and stability in basic research areas such as immunology, stem cell differentiation, and organoid culture.
Premium Grade (Pre-GMP) is tailored for early-stage drug development, manufactured using the same cell clone and production process as the GMP Grade under animal-origin-free conditions. It supports cell bank establishment, process development, and preclinical evaluation. Its core advantage lies in enabling a smooth transition from research to clinical applications, helping biotechnology and cell therapy companies mitigate risks associated with animal-derived components while enhancing process consistency and compliance.
GMP Grade strictly adheres to cGMP standards and serves clinical-phase and commercial production needs. It features a full-process quality system, a traceable supply chain, and comprehensive regulatory documentation support. This grade is suitable for clinical manufacturing, clinical trial material (CTM) preparation, and commercial filling of cell therapy drugs, providing pharmaceutical companies with reliable raw materials that meet global regulatory requirements and ensure final product safety and consistency.
Through tiered product levels, we help users align with appropriate quality standards and cost structures at different R&D stages, accelerating the translation from scientific research to clinical application.
We are committed to empowering groundbreaking scientific discovery with reliable, high-grade reagents. To address the needs of academic researchers for consistency and reproducibility, our Research Grade cytokines and growth factors are produced under stringent, animal-origin-free (AOF) conditions wherever possible. This level of quality is essential for scientists focused on eliminating experimental variables and maximizing the success rate of their research.
Engineered for native conformation and robust biological activity, they undergo rigorous quality control—including protein content, purity, and cell-based bioactivity testing—with endotoxin levels maintained below 0.01 EU/μg. This ensures superior performance in demanding applications such as immunology, stem cell differentiation, and organoid culture.
| Test Item | Standard Method |
|---|---|
|
Protein Content |
Verified by multiple orthogonal methods to avoid absorbance interference-induced errors (UV280/SDS-PAGE/BCA/Bradford/Lowry) |
|
Purity |
>95% as determined by SDS-PAGE. |
|
Biological activity |
Biological activity is calibrated against WHO/NIBSC standards |
|
Sterility |
Sterile filtered through a 0.2-micron filter |
|
Endotoxin Level |
<0.01EU/ug by the LAL method or rFactor C Endotoxin Detection Method |
To meet the stringent requirements of early-stage drug development, we offer Premium Grade (Pre-GMP) cytokines and growth factors, manufactured under animal-origin-free (AOF) conditions with processes mirroring those used for GMP production. These products are critical for developers who require high consistency, defined quality, and a seamless path to clinical-scale manufacturing — particularly addressing concerns for researchers focused on eliminating risks associated with animal-derived components, mammalian pathogens, or regulatory and ethical considerations.
Supported by an enhanced quality control regimen that includes strict monitoring of process-related impurities, sterility testing, and mycoplasma detection, Premium Grade (Pre-GMP) cytokines and growth factors provide a cost-effective, high-quality solution for process development. This de-risks the transition to GMP and streamlines the path to clinical trials, making it an ideal choice for cell therapy companies and researchers advancing preclinical work toward clinical applications.
Cell bank establishment
Early drug screening and optimization
Cell therapy process development and scale-up
Preclinical evaluation of candidate drugs
Our GMP Grade cytokines and growth factors are the highest level of quality and compliance for cell and gene therapy manufacturing. We produce our GMP reagents in strict accordance with current Good Manufacturing Practices (cGMP), providing a reliable, regulatory-compliant source of critical raw materials for clinical and commercial therapeutics. Manufactured in certified cGMP facilities, these products are supported by a comprehensive quality management system and full traceability from raw materials to final product. Each batch is released with extensive documentation to meet global regulatory requirements, ensuring the safety, efficacy, and consistency essential for human use. This enables partners to advance therapies through clinical stages and into commercialization with confidence.
Clinical manufacturing and final formulation of cell therapy products for human transplantation
Production of Clinical Trial Materials (CTM)
Commercial manufacturing for approved therapies
|
Feature |
Research Grade |
Premium Grade |
GMP Grade |
|---|---|---|---|
|
Regulatory Requirements |
Research Use Only |
Pre-GMP Standards |
Full cGMP Compliance |
|
Application Stage |
Basic Research |
Early Development & Process Development |
Clinical Manufacturing & Commercialization |
|
Primary Users |
Academic Institutions |
Biotechnology Companies |
Pharmaceutical Companies |
|
Quality Control |
Basic QC Testing |
Extended QC Testing + Process Impurity Control |
Comprehensive cGMP Quality Control |
|
Biological Activity |
Against WHO/NIBSC standards |
Against WHO/NIBSC standards |
Against WHO/NIBSC standards |
|
Documentation Support |
Certificate of Analysis (CoA) |
CoA + Partial Technical Documentation |
Complete Regulatory Support Files + DMF |
|
Cost Effectiveness |
Economical |
Cost-Effective |
Investment Security |
|
Advantages |
Reliable activity |
Seamless transition to GMP |
cGMP compliant |
We are committed to developing high-quality key reagents for clinical research and commercialization of cell and gene therapies. By following current pharmaceutical manufacturing practices along with more stringent quality management and release testing standards, we strive to provide customers with optimal product solutions. We continuously improve our quality management system to produce high-quality raw materials that meet global regulatory requirements.
Customer audits are welcome, and regular internal audits are conducted to ensure ongoing quality system compliance.
Join us for an exclusive 1-2 hour virtual tour of ACROBiosystems' state-of-the-art GMP facility! Explore our advanced manufacturing, learn about our GMP capabilities, and engage in a live Q&A with our experts. Gain insights into cutting-edge CGT ancillary material manufacturing processes and explore potential collaborations.
Contact Us Today to learn more about professional recommendations for selecting the appropriate cytokine grade for your R&D project.
[North America]: 1 Innovation Way, Newark, DE 19711, USA [Switzerland]: ACRObiosystems AG, c/o Zug Dammstrasse Centre AG, Dammstrasse 19, 6300 Zug Switzerland
Email:order@acrobiosystems.com
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