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Your Position: Home > Key Raw Materials for Cell and Gene Therapy

Key Raw Materials for Cell and Gene Therapy

Key Raw Materials for Cell and Gene Therapy
Background

ACROBiosystems offers a wide range of raw materials and tools needed for cell therapy products, including cytokines, nucleases, and activation beads. We provide several grades of materials, including both premium and GMP grades. Our premium grade proteins originate from the same clone, sequence, and expression system as our GMP products. This means developers utilizing our premium-grade products can be easily transition into GMP products for use in CMC or clinical stages without more comparability studies of the manufacturing process.

Seamlessly transition from preclinical to clinical research
Seamlessly transition from preclinical to clinical research

To facilitate the transition of your cell therapy product into clinical trials and beyond, developing a raw material strategy that considers the end goal is critical. For early-stage research and development of cell therapy, research-use only (RUO) materials are most commonly used. However, as the development progresses into the preclinical or clinical phases, RUO materials that may have been sufficient before do not meet the criteria required to proceed. Most strategies emphasize the use of the highest grades of raw materials available as early as possible; however, this may not always be feasible. Accounting for material grade transitions can help balance both performance and costs when moving onto the next stage.

ACROBiosystems offers several different grades of materials for different development stages in your cell therapy product. Premium grade materials are produced under our rigorous quality control system that incorporates a comprehensive set of tests including sterility and endotoxin tests. Product performance is carefully validated and tested for compatibility for cell culture use or any other applications in the early preclinical stage. When ready to transition into later clinical phases, we also offer a custom GMP protein service that tailors to your needs. GMP grade materials are developed using our GMP-grade quality management system platform. These products are produced with strict quality management and drug-level release testing standards. Since our premium grade components are similar to our GMP products, the transition between grades can be easily performed without further comparability studies.

Premium VS GMP

Premium 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 -by third-party audits
Transient or stable cell linesStable cell lines (Comprehensive external inspections)
Animal-origin free materials or BSE/TSE freeAnimal-origin free materials or BSE/TSE free
Pharmaceutical-grade materialsPharmaceutical-grade materials
Strict 2 grade series sterile filtrationStrict 2 grade series sterile filtration
Class 100 FFUClass B+A cleanroom with automatic filling machine
No additional virus clearance steps in2 additional virus removal and inactivation steps included (nanofiltration + low pH)
Quality ControlSterility / Mycoplasma testingSterility / Mycoplasma testing
Endotoxin control and detectionEndotoxin control and detection
Validated key equipment and analytical instrumentsValidated equipment /analytical instruments/analytical methods(analytical instruments audit trial)
Residual DNA/HCP testingResidual DNA/HCP testing
Limited adventitious agent testingFull adventitious agent testing (virus testing and animal in vivo safety experiments)
DocumentationCommon regulatory supportComprehensive regulatory support files
DMF filing (Few products)DMF filing (All products)
Product List (Online and under development)
CatalogGMP gradePremium grade
CytokineGMP Human IL-7Human IL-7 Protein, premium grade
GMP Human IL-15Human IL-15 Protein, premium grade
GMP Human IL-21Human IL-21 Protein, premium grade
GMP Human IL-18Human IL-18, premium grade
GMP Human TNF-alphaHuman TNF-alpha, premium grade
GMP Human GM-CSFHuman GM-CSF, premium grade
GMP Human IL-6Human IL-6, premium grade
GMP Human IL-4Human IL-4, premium grade
GMP Human IFN-gammaHuman IFN-gamma, premium grade
AntibodyGMP Monoclonal Anti-Human CD3 Antibody(OKT3)Monoclonal Anti-Human CD3 Antibody, Mouse IgG2a (Clone: OKT3), premium grade
GMP Monoclonal Anti-Human CD28 AntibodyMonoclonal Anti-Human CD28 Antibody, Mouse IgG1, premium grade
Magnetic BeadsGMP Anti-CD3/CD28 Antibody-coupled Magnetic BeadsAnti-CD3/CD28 Antibody-coupled Magnetic Beads, premium grade
GENIUS™ NucleaseGMP GENIUS™ NucleaseGENIUS™ Nuclease, premium grade
Cas enzymeGMP NLS-Cas9 NucleaseNLS-Cas9 Nuclease, premium grade
Supporting Data

Similar performances between Premium and GMP grade cytokines

Similar performances between Premium and GMP grade cytokines

Recombinant Human IL-15 Protein premium grade (IL5-H4117), designed for preclinical stage, has the same activity and performance with GMP Grade IL-15 (GMP-L15H13), which  enables a seamless transition from preclinical development to clinical phases .

Similar performances between Premium and GMP grade cytokines

Human IL-7 Protein premium grade (IL7-H4219) designed for preclinical stage, has the same activity and performance with GMP Grade IL-7 (GMP-L07H24), which  enables a seamless transition from preclinical development to clinical phases .

Batch-to-batch Consistency

Batch-to-batch Consistency

Bioactivity of three different lots of GMP Human IL-15 (GMP-L15H13) verified by cell-based assay, and the result shows very high batch-to-batch consistency.

High Stability

High Stability

The Cell based assay shows that GMP Human IL-7 (GMP-L07H24) is stable at 37°C for 48 hours and after freezing and thawing 3 times.

More related products

>> CAR-T targets

>> GMP Grade Cytokines

>> Anti-CD3/CD28 Ab-coupled Magnetic Beads

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