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Wachstumsfaktoren für die Zellkultur

Wachstumsfaktoren für die Zellkultur
Übersicht

Zur Unterstützung der Hersteller und Entwickler von Zelltherapien hat ACROBiosystems eine breite Palette an hochwertigen Zytokinen für die In-vitro-Kultur von Immunzellen, Stammzellen, Organoiden und verschiedenen anderen Zelltypen entwickelt. Wir bieten auch Premium(Pre-GMP) und GMP-Qualitäten für unsere Zytokine an, um den Anforderungen verschiedener Entwicklungsstadien und Anwendungen besser gerecht zu werden. Alle drei Zytokinqualitäten werden nach einem ähnlichen Produktionsverfahren hergestellt, so dass ein nahtloser Übergang zwischen den Qualitäten möglich ist. So ermöglichen wir Ihnen einen nahtlosen Übergang zwischen unseren Produkten und beschleunigen Ihre Forschung und Entwicklung.

Unterschiede zwischen Premium(Pre-GMP) und GMP Grade
Premium(Pre-GMP) klasse GMP-Klasse
Application Research and Development; Preclinical research, seamless transition into clinical phases Designed to meet clinical phase requirements and bolster your IND application to various regulatory bodies.
Quality System ISO 9001 /ISO 13485 Certified ISO 9001 /ISO 13485 Certified (Development stage)
GMP Quality Management System (Production stage)
Production ISO certified facilities GMP certified facilities
Transient or stable cell lines Stable cell lines (Full inspection according to USP and ChP)
Animal-origin free materials or BSE/TSE free Animal-origin free materials or BSE/TSE free
Pharmaceutical-grade materials Pharmaceutical-grade materials
Strict sterilization filtration Strict sterilization filtration
Class C+A room with manual aseptic filling (ISO5) B+A Cleanroom aseptic filling
No additional virus clearance steps Additional specific virus removal processes
Quality Control Sterility / Mycoplasma testing Sterility / Mycoplasma testing
Endotoxin control and detection Endotoxin control and detection
Validated key equipment and analytical instruments Validated equipment /analytical instruments/analytical methods(Audit trail available)
Residual DNA/HCP testing Residual DNA/HCP testing
Limited adventitious agent testing Stricter standards for viral residues alongside animal safety evaluations (select products).
Documentation Common regulatory support Comprehensive regulatory support files
DMF filing (Few products) DMF filing (All products)
GMPvsPremium(Pre-GMP)

Der Übergang von Premium(Pre-GMP) zu GMP

Zytokine sind wichtige Rohstoffe, die bei der Zellkultivierung für zell- und gentherapeutische Arzneimittel (CGT) verwendet werden. In der vorklinischen Phase wird in der Regel weder der Sicherheit noch der Qualität der Rohstoffe Priorität eingeräumt. In diesem Fall können nur Produkte für Forschungszwecke verwendet werden. In späteren Phasen der Arzneimittelentwicklung, z. B. in der CMC- oder klinischen Phase, ist es jedoch notwendig, die Rohstoffe durch GMP-konforme Materialien zu ersetzen, um die behördlichen Richtlinien zu erfüllen. In dieser Übergangsphase wird viel Energie in die Neubewertung und Validierung neuer Rohstoffe gesteckt.

Um den Übergang von der vorklinischen Entwicklung in die klinische Phase zu erleichtern, bieten wir verschiedene Zytokinqualitäten an, die als nahezu identisch in ihrer Bioaktivität bewertet wurden, zusammen mit der für GMP-Produkte erforderlichen Dokumentation. Wir empfehlen die Verwendung unserer Premium(Pre-GMP) Rohstoffe in der frühen Entwicklungsphase, um beim Eintritt in die CMC- oder klinischen Phasen nahtlos auf unsere GMP-Rohstoffe übergehen und die Anzahl der durchgeführten Reevaluierungs- und Validierungsstudien minimieren zu können.

Promotional Event!
From now on to Dec 31th, 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!

Free-sample-application-of-Laminin-proteins

Produktmerkmale

Steril

Tierischen Ursprungs Frei

Hohe Reinheit ≥95%

Hohe Bioaktivität, bestätigt durch zellbasierte Assays

Premium(Pre-GMP) und GMP-Qualitäten verfügbar

Geringes Endotoxin≤0.1 EU/μg

Frei von Trägern

Ähnlich der natürlichen Konformation und Modifikationen

Konsistent von Charge zu Charge

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!

Unterstützende Daten

Hochwertige Zytokine

✔  Humanes IL-2, Premium(Pre-GMP) qualität, kombiniert mit CD3/CD28-Magnetbeads kann T-Zellen mit hoher Aktivität aktivieren
IL2-H5215

ACRO’s Human IL-2, Premium(Pre-GMP) 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).

✔ Konsistenz von Charge zu Charge
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.

✔  Ähnliche Leistungen zwischen Premium(Pre-GMP) und GMP-Produkten
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.

Zytokine in GMP-Qualität

✔  Hohe Bioaktivität
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.

✔  Konsistenz von Charge zu Charge
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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