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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 ActiveMax® (Research-use only), Premium, and GMP grades for our cytokines to better meet the needs of various drug development stages and applications. All three cytokine grades 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 ActiveMax®, Premium and GMP Grade
ActiveMax®Premium GradeGMP Grade
ApplicationResearch and DevelopmentResearch 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 CertifiedISO 9001 /ISO 13485 Certified (Development stage)
                         GMP Quality Management System (Production stage)
ProductionISO certified facilitiesISO certified facilitiesGMP certified facilities
Transient or stable cell linesTransient or stable cell linesStable cell lines (Full inspection according to USP and ChP)
Limited use of animal-derived materialsAnimal-origin free materials or BSE/TSE freeAnimal-origin free materials or BSE/TSE free
Research-grade materialsPharmaceutical-grade materialsPharmaceutical-grade materials
0.22μm filter sterilization filtrationStrict 2 grade series sterile filtrationStrict 2 grade series sterile filtration
Class C+A room with manual aseptic filling (ISO5)Class C+A room with manual aseptic filling (ISO5)Class B+A cleanroom with automatic filling machine
No additional virus clearance stepsNo additional virus clearance steps2 additional virus removal and inactivation steps (nanofiltration + low pH)
Quality ControlSterility testingSterility / Mycoplasma testingSterility / Mycoplasma testing
Endotoxin control and detectionEndotoxin control and detectionEndotoxin control and detection
Validated key equipment and analytical instrumentsValidated key equipment and analytical instrumentsValidated equipment /analytical instruments/analytical methods(Audit trail available)
No process-related impurity residue testingResidual DNA/HCP testingResidual DNA/HCP testing
Limited adventitious agent testingLimited adventitious agent testingComplete adventitious agent testing (virus testing and animal in vivo safety experiments)
DocumentationCommon regulatory supportCommon regulatory supportComprehensive regulatory support files
Non DMF filingDMF filing (Few products)DMF filing (All products)
GMPvsPremium

Transitioning from Premium 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-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.

Promotional Event!
Nov. 15th to Jan 15th, 2023

To match your project schedule, shorten decision times, and save your research and development budget, we are currently offering a free trial of our non-GMP grade products along with our custom GMP product services!

During this campaign, if you are looking for custom GMP-grade products that are a part of our catalog on the official website of ACROBiosystems (www.acrobiosystems.com), we will provide you with a free trial size of our non-GMP grade products (100 µg) to test. Our non-GMP grade products have the same performance as our GMP-grade products for a sneak-peek into our GMP product performance and assist with your transition into GMP!

Product Features

Sterile

Animal-origin Free

High Purity≥95%

High Bioactivity Verified by Cell-based Assay

ActiveMax®, Premium 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.

Click here to inquire now!

Supporting Data

ActiveMax® Cytokines

✔  High purity
GCF-H5214

ActiveMax® Human G-CSF, Tag Free (Cat. No.GCF-H5214) on SDS-PAGE under reducing (R) condition. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 95%.

✔  Lot-to-lot consistency
LIF-H521b

Bioactivity of three different lots of ActiveMax® Recombinant Human LIF (Cat. No. LIF-H521b) is verified by ELISA, and the result shows very high batch-to-batch consistency.

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.

Premium Grade Cytokines

✔  Human IL-2, premium 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 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.

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.

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