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Product Details
Features and Advantages
- Seamless Transition from Preclinical to Clinical: Same cell clone, process, and QC as GMP products.
- Enhanced Production Standards: AOF raw materials, pharma-grade excipients, Grade B+A (ISO 5) environment.
- Comprehensive Quality Control: Additional strict testing for process impurities, sterility, and mycoplasma.
- Cost-Effective Solution: GMP-comparable quality at an economical price for early development.
- Risk Mitigation: Enhanced safety through rigorous impurity control and comprehensive testing.
Synonyms
Apolipoprotein E, APOE, Apo-E
Source
Human APOE3 Protein, premium grade (APE-H5318) is expressed from CHO cells. It contains AA Lys 19 - His 317 (Accession # P02649-1 ).
Predicted N-terminus: Lys 19
It is 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.
GMP-APEH35 is the GMP version of this APE-H5318. These two proteins display indistinguishable performance profiles, thereby ensuring a seamless transition for end users from early preclinical stage to later clinical phases.Request for sequenceMolecular Characterization
Other Tags and Version Biotin & Other Labeled Version
This protein carries no "tag".
The protein has a calculated MW of 34.2 kDa. The protein migrates as 37 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE) due to glycosylation.
Endotoxin
Less than 0.01 EU per μg by the LAL method / rFC method.
Host Cell Protein
<0.5 ng/µg of protein tested by ELISA.
Host Cell DNA
<0.001 ng/μg of protein tested by qPCR.
Sterility
Negative
Mycoplasma
Negative
Purity
>95% as determined by SDS-PAGE.
Formulation
Lyophilized from 0.22 μm filtered solution in 20 mM MOPS, 150 mM NaCl, pH7.3 with trehalose as protectant.
Contact us for customized product form or formulation.
Reconstitution
Please see Certificate of Analysis for specific instructions.
For best performance, we strongly recommend you to follow the reconstitution protocol provided in the CoA.
Shipping and Storage
This product is shipped at ambient temperature.
For long term storage, the product should be stored at lyophilized state at -20°C or lower.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
- -20°C to -70°C for 12 months in lyophilized state;
- -70°C for 3 months under sterile conditions after reconstitution.
ACRO Quality Management System
Quality Description
ACRO's Research-grade products are suitable for a wide range of cell culture applications, particularly for research use in academic institutions. These products are sterilized by filtration, followed by lyophilization where applicable. Typical specifications include endotoxin levels of <0.01 EU/μg and purities >95%. Biological activity is calibrated against WHO/NIBSC standards when available.
ACRO's Premium-grade (Pre-GMP) products are characterized by their high quality and enhanced safety profiles, making them ideal for early-stage discovery and manufacturing processes in cell therapy companies. A key advantage is their seamless transition to corresponding GMP-grade versions. Biological activity is calibrated against WHO/NIBSC standards when available. Typical specifications include endotoxin levels of <0.01 EU/μg and purities >95%. In addition, rigorous testing is conducted to ensure the absence of mycoplasma, HCD, and HCP, thereby guaranteeing product safety.
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Performance Data
SDS-PAGE
Human APOE3 Protein, premium grade on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95% (With Star Ribbon Pre-stained Protein Marker).
Bioactivity-ELISA
Immobilized Human APOE3 Protein, premium grade (Cat. No. APE-H5318) at 5 μg/mL (100 μL/well) can bind Human LDL R, Fc Tag (Cat. No. LDR-H5251) with a linear range of 0.078-2.5 μg/mL (Routinely tested).
Protocol
Immobilized Human APOE3 Protein, premium grade (Cat. No. APE-H5318) at 5 μg/mL (100 μL/well) can bind Human VLDL R, His Tag (Cat. No. VLR-H5227) with a linear range of 0.078-1.25 μg/mL (Routinely tested).
Protocol
Bioactivity-SPR
Human VLDL R, His Tag (Cat. No. VLR-H5227) immobilized on CM5 Chip can bind Human APOE3 Protein, premium grade (Cat. No. APE-H5318) with an affinity constant of 6.94 nM as determined in a SPR assay (Biacore8K) (QC tested).
Protocol
Application Data
T cells purified by CD4 (ACRO, Cat. No. MBS-S004) and CD8 (ACRO, Cat. No. MBS-S005) NanoSort Microbeads sorting were activated with T cell Activation/Expansion CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001) for 24 h, then seeded at 1 × 10⁵ cells/well and treated with 1 μg/mL LNP and 0.1 μg/mL Human APOE3 Protein, premium grade (ACRO, Cat. No. APE-H5318). After incubation at 37 °C with 5% CO₂ for 6 h or 21 h, cells were harvested and analyzed by flow cytometry for GFP fluorescence intensity, with cell viability assessed via 7-AAD staining. The results showed that, compared with LNP alone, the combination with APOE3 significantly increased the percentage of GFP-positive cells (Figure A,B,C) and the mean fluorescence intensity (MFI) (Figure D), whereas cell viability did not differ significantly among groups (Figure E). Data are presented as the mean ± SD (n=3).
T cells purified by CD4 (ACRO, Cat. No. MBS-S004) and CD8 (ACRO, Cat. No. MBS-S005) NanoSort Microbeads sorting were activated with T cell Activation/Expansion CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001) for 24 h, then seeded at 1 × 10⁵ cells/well and treated with 1 μg/mL LNP and 0.1 μg/mL Human APOE3 Protein, premium grade (ACRO, Cat. No. APE-H5318). After incubation at 37 °C with 5% CO₂ for 6 h or 21 h, cells were harvested and analyzed by flow cytometry for GFP fluorescence intensity, with cell viability assessed via 7-AAD staining. The results showed that, compared with LNP alone, the combination with APOE3 significantly increased the percentage of GFP-positive cells (Figure A,B,C) and the mean fluorescence intensity (MFI) (Figure D), whereas cell viability did not differ significantly among groups (Figure E). Data are presented as the mean ± SD (n=3).
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FAQ
- product
Can lyophilized proteins remain stable during room-temperature shipping or temporary room-temperature exposure?
In general, lyophilized proteins remain stable during room-temperature shipping or temporary exposure to room-temperature conditions.
Many ACROBiosystems recombinant proteins are supplied in lyophilized (freeze-dried) form. The lyophilization process effectively removes moisture from the product, helping reduce degradation-related reactions and improve protein stability during transportation and storage.
To evaluate the stability of lyophilized proteins under normal temperature conditions, ACROBiosystems conducted a stability study on 11 representative lyophilized protein products at 37°C. The study demonstrated that these proteins maintained good quality stability after storage at 37°C for approximately 20 days. Based on these validation results, temporary room-temperature exposure during shipping or handling is generally not expected to have a significant impact on product quality or downstream application performance.
To ensure optimal long-term stability, products should be stored according to the storage conditions specified in the product Certificate of Analysis (COA) upon receipt.
Supporting Document
Background
Recent Advances
Drug Development Progress- English Name：
Apolipoprotein E
- Category：
- Approved Drugs：
0 Details
- Drugs in Clinical Trials：
3 Details
- Highest Development Stage：
Phase 2 Clinical
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