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Growth Factors for Cell Culture

To support ongoing cell therapy manufacturers and developers, ACROBiosystems has developed a wide array of high-quality cytokines for the in vitro culture of immune cells, stem cells, organoids, and various other cell types. We also offer Premium(Pre-GMP) and GMP grades for our cytokines to better meet the needs of various drug development stages and applications. All the cytokines are manufactured using a similar production process, therefore enabling a seamless transition between grades. As a result, we enable you to seamlessly transition between our products and accelerate your research and development.

Differences of Premium(Pre-GMP) and GMP Grade
Premium(Pre-GMP) GradeGMP Grade
ApplicationResearch and Development; Preclinical research, seamless transition into clinical phasesDesigned to meet clinical phase requirements and bolster your IND application to various regulatory bodies.
Quality SystemISO 9001 /ISO 13485 CertifiedISO 9001 /ISO 13485 Certified (Development stage)
GMP Quality Management System (Production stage)
ProductionISO certified facilitiesGMP certified facilities
Transient or stable cell linesStable cell lines (Full inspection according to USP and ChP)
Animal-origin free materials or BSE/TSE freeAnimal-origin free materials or BSE/TSE free
Pharmaceutical-grade materialsPharmaceutical-grade materials
Strict sterilization filtrationStrict sterilization filtration
Class C+A room with manual aseptic filling (ISO5)B+A Cleanroom aseptic filling
No additional virus clearance stepsAdditional specific virus removal processes
Quality ControlSterility / Mycoplasma testingSterility / Mycoplasma testing
Endotoxin control and detectionEndotoxin control and detection
Validated key equipment and analytical instrumentsValidated equipment /analytical instruments/analytical methods(Audit trail available)
Residual DNA/HCP testingResidual DNA/HCP testing
Limited adventitious agent testingStricter standards for viral residues alongside animal safety evaluations (select products).
DocumentationCommon regulatory supportComprehensive regulatory support files
DMF filing (Few products)DMF filing (All products)
GMPvsPremium(Pre-GMP)

Transitioning from Premium(Pre-GMP) to GMP

Cytokines are critical raw materials used in cell culturing for cell and gene therapy (CGT) drugs. Usually, in the preclinical stage, both safety and quality for raw materials are not prioritized. In this case, research-use only products can be used. However, when progressing into later drug development stages such as CMC or clinical phases, it is necessary to replace the raw materials with GMP-grade materials to be compliant with regulatory guidelines. In this transitional period, there is a significant amount of energy dedicated to re-evaluating and validating new raw materials.

To ease this transition from the preclinical development into the clinical stage, we offer several grades of cytokines that have been evaluated to be near-identical in bioactivity, along with the documentation required from GMP products. We recommend using our Premium(Pre-GMP) grade raw materials in the early development stage to seamlessly transition to our GMP-grade raw materials when entering CMC or clinical phases and minimize the number of re-evaluation and validation studies performed.

Overview

To support ongoing cell therapy manufacturers and developers, ACROBiosystems has developed a wide array of high-quality cytokines for the in vitro culture of immune cells, stem cells, organoids, and various other cell types. We also offer Premium(Pre-GMP) and GMP grades for our cytokines to better meet the needs of various drug development stages and applications. All the cytokines are manufactured using a similar production process, therefore enabling a seamless transition between grades. As a result, we enable you to seamlessly transition between our products and accelerate your research and development.

Differences of Premium(Pre-GMP) and GMP Grade
Premium(Pre-GMP) GradeGMP Grade
ApplicationResearch and Development; Preclinical research, seamless transition into clinical phasesDesigned to meet clinical phase requirements and bolster your IND application to various regulatory bodies.
Quality SystemISO 9001 /ISO 13485 CertifiedISO 9001 /ISO 13485 Certified (Development stage)
GMP Quality Management System (Production stage)
ProductionISO certified facilitiesGMP certified facilities
Transient or stable cell linesStable cell lines (Full inspection according to USP and ChP)
Animal-origin free materials or BSE/TSE freeAnimal-origin free materials or BSE/TSE free
Pharmaceutical-grade materialsPharmaceutical-grade materials
Strict sterilization filtrationStrict sterilization filtration
Class C+A room with manual aseptic filling (ISO5)B+A Cleanroom aseptic filling
No additional virus clearance stepsAdditional specific virus removal processes
Quality ControlSterility / Mycoplasma testingSterility / Mycoplasma testing
Endotoxin control and detectionEndotoxin control and detection
Validated key equipment and analytical instrumentsValidated equipment /analytical instruments/analytical methods(Audit trail available)
Residual DNA/HCP testingResidual DNA/HCP testing
Limited adventitious agent testingStricter standards for viral residues alongside animal safety evaluations (select products).
DocumentationCommon regulatory supportComprehensive regulatory support files
DMF filing (Few products)DMF filing (All products)
GMPvsPremium(Pre-GMP)

Transitioning from Premium(Pre-GMP) to GMP

Cytokines are critical raw materials used in cell culturing for cell and gene therapy (CGT) drugs. Usually, in the preclinical stage, both safety and quality for raw materials are not prioritized. In this case, research-use only products can be used. However, when progressing into later drug development stages such as CMC or clinical phases, it is necessary to replace the raw materials with GMP-grade materials to be compliant with regulatory guidelines. In this transitional period, there is a significant amount of energy dedicated to re-evaluating and validating new raw materials.

To ease this transition from the preclinical development into the clinical stage, we offer several grades of cytokines that have been evaluated to be near-identical in bioactivity, along with the documentation required from GMP products. We recommend using our Premium(Pre-GMP) grade raw materials in the early development stage to seamlessly transition to our GMP-grade raw materials when entering CMC or clinical phases and minimize the number of re-evaluation and validation studies performed.

Overview

To support ongoing cell therapy manufacturers and developers, ACROBiosystems has developed a wide array of high-quality cytokines for the in vitro culture of immune cells, stem cells, organoids, and various other cell types. We also offer Premium(Pre-GMP) and GMP grades for our cytokines to better meet the needs of various drug development stages and applications. All the cytokines are manufactured using a similar production process, therefore enabling a seamless transition between grades. As a result, we enable you to seamlessly transition between our products and accelerate your research and development.

Differences of Premium(Pre-GMP) and GMP Grade
Premium(Pre-GMP) GradeGMP Grade
ApplicationResearch and Development; Preclinical research, seamless transition into clinical phasesDesigned to meet clinical phase requirements and bolster your IND application to various regulatory bodies.
Quality SystemISO 9001 /ISO 13485 CertifiedISO 9001 /ISO 13485 Certified (Development stage)
GMP Quality Management System (Production stage)
ProductionISO certified facilitiesGMP certified facilities
Transient or stable cell linesStable cell lines (Full inspection according to USP and ChP)
Animal-origin free materials or BSE/TSE freeAnimal-origin free materials or BSE/TSE free
Pharmaceutical-grade materialsPharmaceutical-grade materials
Strict sterilization filtrationStrict sterilization filtration
Class C+A room with manual aseptic filling (ISO5)B+A Cleanroom aseptic filling
No additional virus clearance stepsAdditional specific virus removal processes
Quality ControlSterility / Mycoplasma testingSterility / Mycoplasma testing
Endotoxin control and detectionEndotoxin control and detection
Validated key equipment and analytical instrumentsValidated equipment /analytical instruments/analytical methods(Audit trail available)
Residual DNA/HCP testingResidual DNA/HCP testing
Limited adventitious agent testingStricter standards for viral residues alongside animal safety evaluations (select products).
DocumentationCommon regulatory supportComprehensive regulatory support files
DMF filing (Few products)DMF filing (All products)
GMPvsPremium(Pre-GMP)

Transitioning from Premium(Pre-GMP) to GMP

Cytokines are critical raw materials used in cell culturing for cell and gene therapy (CGT) drugs. Usually, in the preclinical stage, both safety and quality for raw materials are not prioritized. In this case, research-use only products can be used. However, when progressing into later drug development stages such as CMC or clinical phases, it is necessary to replace the raw materials with GMP-grade materials to be compliant with regulatory guidelines. In this transitional period, there is a significant amount of energy dedicated to re-evaluating and validating new raw materials.

To ease this transition from the preclinical development into the clinical stage, we offer several grades of cytokines that have been evaluated to be near-identical in bioactivity, along with the documentation required from GMP products. We recommend using our Premium(Pre-GMP) grade raw materials in the early development stage to seamlessly transition to our GMP-grade raw materials when entering CMC or clinical phases and minimize the number of re-evaluation and validation studies performed.

Overview

To support ongoing cell therapy manufacturers and developers, ACROBiosystems has developed a wide array of high-quality cytokines for the in vitro culture of immune cells, stem cells, organoids, and various other cell types. We also offer Premium(Pre-GMP) and GMP grades for our cytokines to better meet the needs of various drug development stages and applications. All the cytokines are manufactured using a similar production process, therefore enabling a seamless transition between grades. As a result, we enable you to seamlessly transition between our products and accelerate your research and development.

Differences of Premium(Pre-GMP) and GMP Grade
Premium(Pre-GMP) GradeGMP Grade
ApplicationResearch and Development; Preclinical research, seamless transition into clinical phasesDesigned to meet clinical phase requirements and bolster your IND application to various regulatory bodies.
Quality SystemISO 9001 /ISO 13485 CertifiedISO 9001 /ISO 13485 Certified (Development stage)
GMP Quality Management System (Production stage)
ProductionISO certified facilitiesGMP certified facilities
Transient or stable cell linesStable cell lines (Full inspection according to USP and ChP)
Animal-origin free materials or BSE/TSE freeAnimal-origin free materials or BSE/TSE free
Pharmaceutical-grade materialsPharmaceutical-grade materials
Strict sterilization filtrationStrict sterilization filtration
Class C+A room with manual aseptic filling (ISO5)B+A Cleanroom aseptic filling
No additional virus clearance stepsAdditional specific virus removal processes
Quality ControlSterility / Mycoplasma testingSterility / Mycoplasma testing
Endotoxin control and detectionEndotoxin control and detection
Validated key equipment and analytical instrumentsValidated equipment /analytical instruments/analytical methods(Audit trail available)
Residual DNA/HCP testingResidual DNA/HCP testing
Limited adventitious agent testingStricter standards for viral residues alongside animal safety evaluations (select products).
DocumentationCommon regulatory supportComprehensive regulatory support files
DMF filing (Few products)DMF filing (All products)
GMPvsPremium(Pre-GMP)

Transitioning from Premium(Pre-GMP) to GMP

Cytokines are critical raw materials used in cell culturing for cell and gene therapy (CGT) drugs. Usually, in the preclinical stage, both safety and quality for raw materials are not prioritized. In this case, research-use only products can be used. However, when progressing into later drug development stages such as CMC or clinical phases, it is necessary to replace the raw materials with GMP-grade materials to be compliant with regulatory guidelines. In this transitional period, there is a significant amount of energy dedicated to re-evaluating and validating new raw materials.

To ease this transition from the preclinical development into the clinical stage, we offer several grades of cytokines that have been evaluated to be near-identical in bioactivity, along with the documentation required from GMP products. We recommend using our Premium(Pre-GMP) grade raw materials in the early development stage to seamlessly transition to our GMP-grade raw materials when entering CMC or clinical phases and minimize the number of re-evaluation and validation studies performed.

Product Features

Free-sample-application-of-Laminin-proteins

Sterile

Animal-origin Free

High Purity≥95%

High Bioactivity Verified by Cell-based Assay

Premium(Pre-GMP) and GMP Grades Available

Low Endotoxin≤0.1 EU/μg

Carrier Free

Similar to Natural Conformation and Modifications

Consistent between Batches

Product Features

Free-sample-application-of-Laminin-proteins

Sterile

Animal-origin Free

High Purity≥95%

High Bioactivity Verified by Cell-based Assay

Premium(Pre-GMP) and GMP Grades Available

Low Endotoxin≤0.1 EU/μg

Carrier Free

Similar to Natural Conformation and Modifications

Consistent between Batches

Product Features

Free-sample-application-of-Laminin-proteins

Sterile

Animal-origin Free

High Purity≥95%

High Bioactivity Verified by Cell-based Assay

Premium(Pre-GMP) and GMP Grades Available

Low Endotoxin≤0.1 EU/μg

Carrier Free

Similar to Natural Conformation and Modifications

Consistent between Batches

Product Features

Free-sample-application-of-Laminin-proteins

Sterile

Animal-origin Free

High Purity≥95%

High Bioactivity Verified by Cell-based Assay

Premium(Pre-GMP) and GMP Grades Available

Low Endotoxin≤0.1 EU/μg

Carrier Free

Similar to Natural Conformation and Modifications

Consistent between Batches

Product List

Product List

Product List

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Custom GMP-grade Protein Services

Custom GMP-grade Protein Services

Custom GMP-grade Protein Services

Custom GMP-grade Protein Services

Supporting Data

Supporting Data

Supporting Data

Supporting Data

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  • Overview
  • Overview
  • Overview
  • Product Features
  • Product Features
  • Product Features
  • Product Features
  • Product List
  • Product List
  • Product List
  • Product List
  • Custom GMP-grade Protein Services
  • Custom GMP-grade Protein Services
  • Custom GMP-grade Protein Services
  • Custom GMP-grade Protein Services
  • Supporting Data
  • Supporting Data
  • Supporting Data
  • Supporting Data
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