Cytokine Product Portfolio - Complete Solutions from Research to Clinical Manufacturing

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

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)

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

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.

Research Grade – For foundational scientific discovery

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.

Research Grade – For foundational scientific discovery

Product Features and Advantages
Native Conformation: Native sequences, tag-free, ensuring natural conformation and function
Reliable Activity: Biological activity calibrated against WHO/NIBSC standards
Stringent Quality Control: Each batch undergoes protein content, purity, endotoxin and cell-based bioactivity testing
Low Endotoxin level: Endotoxin levels <0.01 EU/μg
Safety Assurance: Sterile filtration through 0.2μm membrane
AOF: Most Research Grade products produced using animal origin-free raw materials throughout production process
Quality Control Standards
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

Premium Grade – Bridging research and clinical development

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.

 Premium Grade – Bridging research and clinical development

Premium Grade (Pre-GMP) Products are highly recommended for:
Researchers with preclinical programs seeking to advance to clinical trials or manufacturing stages
Researchers who require defined culture conditions or are struggling with experimental variability
Researchers who need to avoid animal-derived reagents due to regulatory requirements or ethical considerations
Cell therapy companies engaged in pre-clinical and process development activities
Product Features and Advantages
Seamless Transition: Utilizes the same cell clone or strain, manufacturing process, critical process parameters, and QC testing methods as corresponding GMP products to ensure the comparable performance and characteristics to GMP products
Enhanced Production Standards: Manufactured with Animal Origin-Free (AOF) raw materials and pharmaceutical-grade excipients in Grade B+A (ISO 5) cleanroom environment
Comprehensive Quality Control: Each batch is tested for bioactivity and endotoxin, with stringent monitoring of process-related impurities, sterility, and mycoplasma
Cost-Effective Solution: Provides GMP-level quality at an economical price point for early development stages
Risk Mitigation: Strict impurity control and comprehensive testing ensure enhanced safety profile for critical applications
Recommended Applications

Cell bank establishment

Early drug screening and optimization

Cell therapy process development and scale-up

Preclinical evaluation of candidate drugs

GMP Grade – For clinical and commercial manufacturing

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.

GMP Grade – For clinical and commercial manufacturing

Product Features and Advantages
Quality Assurance: State-of-the-art global quality management system, with comprehensive and stringent QC release testing criteria.
End-to-End GMP Compliance: Entire manufacturing and quality control process conducted under cGMP system.
Comprehensive Control of Adventitious Agent Contamination: From cell banks/bacterial seed banks through fill-finish process to final release testing, upholding stringent biosafety standards.
Comprehensive Regulatory Support and Regulatory Compliance: Includes detailed Regulatory Support Files (RSF) and available Drug Master Files (DMF) to meet global regulatory requirements for cell and gene therapy manufacturing.
Resilient Supply Chain: Through an intelligent modular facility design that addresses diverse production needs, we ensure a stable and secure global supply chain.
Professional Support: Leveraging extensive protein manufacturing expertise and application development capabilities to accelerate cell therapy process and drug commercialization.
Quality Management System
GMP-certified facility (compliance with FDA cGMP, EMA GMP, ICH,ISO9001/13485/MDSAP and certified by third-party SGS, UL and RX360)
Animal origin-free materials, equipment, and facilities
Materials sourced only from approved suppliers
ISO 5 cleanrooms and automatic filling equipment
Professional quality personnel and training programs
Validated analytical testing methods in accordance with the ICH guidelines
Safety Testing (Sterility, Mycoplasma, etc): compliant with USP, EP ,etc
In-depth stability studies
Recommended Applications

Clinical manufacturing and final formulation of cell therapy products for human transplantation

Production of Clinical Trial Materials (CTM)

Commercial manufacturing for approved therapies

Product Selection Guide

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
Low entodoxin
Good batch consistency

Seamless transition to GMP
AOF Process

cGMP compliant
AOF process
Adventitious control

Our Commitment to Quality

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.

  • Product Overview
  • Research Grade – For foundational scientific discovery
  • Premium Grade – Bridging research and clinical development
  • GMP Grade – For clinical and commercial manufacturing
  • Product Selection Guide
  • Our Commitment to Quality
  • Related Recommendations
Contact Us

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