>Key Raw Materials for Cell and Gene Therapy
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.
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 Grade||GMP Grade|
|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 -by third-party audits|
|Transient or stable cell lines||Stable cell lines (Comprehensive external inspections)|
|Animal-origin free materials or BSE/TSE free||Animal-origin free materials or BSE/TSE free|
|Pharmaceutical-grade materials||Pharmaceutical-grade materials|
|Strict sterile filtration||Validation of aseptic filling process+Strict sterile filtration+ Membrane integrity test|
|Class B+A cleanroom with automatic filling machine||PMS Continuous Environmental Monitoring System, Class B+A cleanroom with automatic filling machine|
|No additional virus clearance steps in||2 additional virus removal and inactivation steps included (nanofiltration + low pH)|
|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（analytical instruments audit trial）|
|Residual DNA/HCP testing||Residual DNA/HCP testing|
|Limited adventitious agent testing||Full adventitious agent testing （virus testing and animal in vivo safety experiments）|
|Documentation||Common regulatory support||Comprehensive regulatory support files|
|DMF filing (Few products)||DMF filing (All products)|
|GMP grade||Premium grade|
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 .
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.
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.
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