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Growth Factors for Cell Culture

Cyt okines for Cell Culture
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.

Free-sample-application-of-Laminin-proteins

Product Features

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

Custom GMP-grade Protein Services

With a portfolio of over 5,000 recombinant proteins and an industry-leading, scale-up ready protein development platform, ACROBiosystems has accumulated over 10 years of experience in developing recombinant proteins. Using this platform, our custom GMP-grade protein services are designed to ensure that our proteins are both structurally designed and validated for cellular therapies manufacturing. We take care to adhere strictly to the GMP guidelines with our comprehensive quality management system and quality controls, providing you with high-quality raw materials without disrupting your development process. Our custom GMP-grade protein service is a one-stop service based on your needs to maximize your therapy’s success. We offer two different developmental processes: converting our non-GMP protein products to GMP or developing a custom GMP-grade protein product from scratch.

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Supporting Data

Premium(Pre-GMP) Grade Cytokines

✔  Human IL-2, Premium(Pre-GMP) grade combined with CD3/CD28 magnetic beads can activate T cells with high activity
IL2-H5215

ACRO’s Human IL-2, premium grade (Cat. No.IL2-H5215) has higher bioactivity than that of other competitors when activates T cell with CD3/CD28 magnetic beads at different concentrations.

MBS-C001

ACRO’s anti-CD3/CD28 antibody-coupled magnetic beads (Cat. No. MBS-C001) combined with Human IL-2 (Cat. No.  IL2-H5215 ) premium grade activate T cells from two donors under three different commercial media, and the result shows high activity with recommended ratio(1:1, beads/cells).

✔ Lot-to-lot consistency
TG1-H4212

Bioactivity of three different lots of Recombinant Human TGF-Beta 1 TGFB1 (Cat. No. TG1-H4212) is verified by cell-based assay, and the result shows very high batch-to-batch consistency.

VE5-H4210

Bioactivity of three different lots of Recombinant Human VEGF165 (Cat. No. VE5-H4210) is verified by cell-based assay, and the result shows very high batch-to-batch consistency.

✔  Similar performances between Premium(Pre-GMP) and GMP grade products
GMP-L15H13

Recombinant Human IL-15 Protein (premium grade), designed for preclinical stage, has the same functional activity and performance as GMP Grade IL-15 (Cat. No.GMP-L15H13), which enables a seamless transition from preclinical development to clinical phases.

GMP-L07H24

Human IL-7 Protein (premium grade) designed for preclinical stage, has the same functional activity and performance as GMP Grade IL-7 (Cat. No. GMP-L07H24), which enables a seamless transition from preclinical development to clinical phases.

✔  Support the growth of organoids
purity_VE5-H4210

Human EGF (Cat. EGF-H52H3), Noggin (Cat. NON-H5257) and R-spondin1 (Cat. RS6-H4220) could support the growth of mouse intestinal organoids.

GMP Grade Cytokines

✔  High bioactivity
GMP-L07H24

GMP Human IL-7 (Cat. No.GMP-L07H24) stimulates proliferation of PHA-P-activated human peripheral blood mononuclear cell (PBMC). The EC50 for this effect is 3.821 ng/mL, corresponding to a specific activity of > 1.0 ⅹ10^8 IU/mg, which is calibrated against human IL-7 WHO International Standard (NIBSC code: 90/530) (QC tested).

GMP-L07H24

The cell-based assay shows that GMP Human IL-7 (Cat. No. GMP-L07H24) is stable at 37°C for 48 hours and after freezing and thawing 3 times.

✔  Lot-to-lot consistency
GMP-L15H13

Bioactivity of three different lots of  GMP Human IL-15 (Cat. No.GMP-L15H13) verified by cell-based assay, and the result shows very high batch-to-batch consistency.

GMP-L07H24

The activity of GMP Human IL-7 (Cat. No. GMP-L07H24) was higher than that of other competitors.

ACRO Quality

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