>Förderung der Entwicklung von biopharmazeutischen Arzneimitteln durch strenge Qualitätsmanagementsysteme
Überblick über die Qualität
Prozess der Qualitätskontrolle
• the basis and premise of complying with the relevant national or regional laws and regulations
• Social awareness: the purpose and social value of our company come from whether customers recognize and are satisfied with our work
• Service awareness: to guide daily work, provide services and create value for customers from the needs and concerns of external and internal customers
• Market awareness: to design products and service procedures and carry out other activities from the perspective of customers' reception and usage habits when carrying out work or making decisions
• Good profits and cash flows
• High operational efficiency and output
• Good brand awareness and customer relations
• Powerful support from our internal team
• Leading market dominance
Application-oriented development strategies
Over 95% of proteins are produced from HEK293 to ensure the native conformation of our proteins
Six guaranteed technology platforms for multi-pass transmembrane proteins, next-generation fluorescent site-directed labeling, and enzymology
Custom products according to customer application requirements
Strict quality control systems
Strict quality and production process control
Validated analytical methodologies
DMF (FDA) filings for recombinant protein products
ISO9001 and ISO13485 certified
GMP quality management system
CNAS-accredited SPR testing services available
24h Technical support and free resources
24-hour technical support on weekdays
Free protocols on bioactivity validation
Open-access marketing information & training resources
Resources for monitoring clinical progress and market dynamics
Comprehensive regulatory support documentation
Extensive collaborations with our partners
|Better Customer Service|
Customers come first
1 to 5-day global shipping
Real-time, online support or local customer support available
Custom services available according to customer demands
Inventory reservation system to reserve the same batch or lot
Suppliers should pass ISO quality system certification and have an effective quality management system.
Hardware facilities such as production workshops should strictly meet the requirements of GMP regulations and provide necessary documentation such as providing audit certificates from third-party authorities, such as drug production license, GMP audit reports from well-known third-party organizations, other qualification documents, etc.
The suppliers should have advanced R&D and production technology, qualified manufacturing process and capabilities, and the capacity for continuous production and supply.
"Good, structurally-defined protein products can reduce the uncertainty and lower the risk in every step of drug research and development.”
Purity testing methods commonly used by ACROBiosystems include SDS-PAGE, HPLC, and MALS.
SDS-polyacrylamide gel electrophoresis (SDS-PAGE), is an analytical detection technique of proteins. It is mostly used to determine the proportion and content of target and miscellaneous proteins. However, since the proteins are denatured before analysis, it is hard to monitor the aggregation of proteins in solution.
MALS validation of purity is a key advantage of ACROBiosystems,which ensures correct protein structure, controllable protein aggregation state, homogeneity and batch-to-batch consistency. This is also the basis for consistent results of ELISA, SPR, and BLI activity validation. Therefore, we know that customers invested in biopharmaceutical development understand that the aggregation state and batch variation of proteins used are critical.
ACROBiosystems is committed to helping customers minimize the risks of drug research and development, ensuring purity levels for customers, and providing customers with high-quality recombinant proteins that are homogenous, consistent between batches, and more importantly, have the correct structure.
As protein structure is the basis for functional activity, only proteins that are close to its natural conformation can properly perform and mimic its biological functions. In particular, the natural aggregation of proteins and correct formation of disulfide bonds are critical in maintaining the correct structure of proteins, and should be the main focus when developing of target proteins. ACROBiosystems selects HEK293 as the expression system of host cells, since proteins expressed by HEK293 system are better modified, including glycosylation modification, therefore closely resembling the natural conformation within human body. This cannot be achieved by other prokaryotic expression system or non-human eukaryotic system. As a critical raw material of antibody drug development, the high-quality target protein with natural conformation and correct structure can significantly increase the success rate of antibody drug development and reduce the uncertainty of drug development in critical application scenarios, such as antibodies acquisition by immunization, screening of functional antibodies and clinical validation of antibody effectiveness.
In the process of developing a target protein, it can be frequently observed that the same protein product performs completely differently under a real application scenarios. Therefore, it is necessary to establish the goals before the start of R&D and clarify the target application scenarios of the protein.
ACROBiosystems tests our protein under the target application scenario during the development process evaluates the protein performance under a simulated application scenario.
ACROBiosystems products have high batch-to-batch consistency, which requires strict control of the protein manufacturing process under a well-established quality system. This ensures a high degree of consistency between product batches.
We maintain our protein products so they can be consistently produced over time, continuing consistent quality and supporting long-term demand for proteins within the development process and throughout the life cycle of biopharmaceuticals. ACROBiosystems has over 200 professionals working in product R&D to ensure that the capability of new product development is fully guaranteed.
● Suppliers should pass ISO quality system certification and have an effective quality management system.
● Hardware facilities such as production workshops should strictly meet the requirements of GMP regulations and provide necessary documentation such as providing audit certificates from third-party authorities, such as drug production license, GMP audit reports from well-known third-party organizations, other qualification documents, etc.
● The suppliers should have advanced R&D and production technology, qualified manufacturing process and capabilities, and the capacity for continuous production and supply.
● Comprehensive analysis and characterization is performed, including identification, content, purity, biological activity, moisture, process-related impurities, potential contaminants, etc.
● The products are fully validated in practical application scenarios, and their performance can meet the application requirements (such as T cell culture and activation experiments).
● Each analytical procedure is systemically validated and traced, which is accurate, reliable and repeatable. Procedures can also be used for accurate analysis and verification of the product quality, along with long-term monitoring of the batch differences of manufacturing.
● The integrity of analytical data meets all regulatory requirements.
● Production raw materials, plant equipment, laboratory analysis and testing, product packaging and storage meet the regulatory requirements of GMP quality management system and cell therapy raw materials.
● The key production parameters are strictly controlled, and the production process is stable and reliable.
● The batch differences of production are continuously monitored and analyzed, and OOS deviation analysis is performed.
● Product stability is fully evaluated to ensure stable and reliable performance during transportation, storage and use.
● Our products undergo testing including sterility, bacterial endotoxin, virus, mycoplasma, related impurity content (HCP, DNA, antibiotics), final product residues, other miscellanies (foreign matter, additives, etc.)
● We provide a comprehensive set of documentation on safety, including proof of origin, Certificate of Analysis (COA), outsourced test report and related qualification certification, packing instructions, TSE/BSE-free statement, animal origin-free (AOF) statement, DMF documents, RSF regulatory support documents, etc.
The Cell based assay shows that ActiveMax Human IL-7 （Cat. No. IL7-H4219） is stable at 37°C for 48 hours.
The Cell based assay shows that ActiveMax Human IL-7 （Cat. No. IL7-H4219） is stable at freezing and thawing 3 times.
The Cell based assay shows that Monoclonal Anti-Human CD3 Antibody （Cat. No. CDE-M120a） is stable at 4°C for 1 year.
The Cell based assay shows that Human IL-15 （Cat. No. GMP-L15H13） is stable at 37°C for 14 days.
|Validation item||Test method||Traceability method|
|Validation criteria||Validation result||Validation criteria||Validation result|
|Different analysts on the same day||RSD≤3%||0%||RSD≤3%||3%|
|Same analyst on different days||RSD≤3%||0%||RSD≤3%||3%|
|Linearity and range||R2>0.999||0.9996||R2>0.999||0.9999|
ActiveMax® Human VEGF165， Tag Free （MALS verified） on SDS-PAGE under reducing （R） and non-reducing （NR） conditions. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 98%.
Human IL-7 on SDS-PAGE under reducing （R） condition. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 95%.
The purity of ActiveMax® Human VEGF165， Tag Free （MALS verified） （Cat. No. VE5-H4210） is more than 95% in HP-SEC， and the molecular weight of this protein is around 40-55 kDa verified by SEC-MALS.
The mean peak Radius of VLP is 60-80 nm with more than 95% intensity as determined by dynamic light scattering （DLS）.
Immobilized Human IL-17 RE （155-454）， Fc Tag （Cat. No. ILE-H5256） at 2 μg/mL （100 μL/well） can bind Biotinylated Mouse IL-17C， His，Avitag （Cat. No. ILC-M82E9） with a linear range of 0.2-20 ng/mL （QC tested）.
FACS assay shows that Biotinylated Human SIRP alpha， Fc，Avitag （Cat. No. CDA-H82F2） can bind to Jurkat cell expressing CD47. The concentration of SIRP alpha used is 3 μg/mL （QC tested）.
FACS analysis shows that the binding of Biotinylated Human SIRP alpha， Fc，Avitag （Cat. No. CDA-H82F2） to Jurkat expressing CD47 was inhibited by increasing concentration of neutralizing Anti- Human CD47 antibody. The concentration of SIRP alpha used is 1 μg/mL. IC50=0.1303 μg/mL （Routinely tested）.
ActiveMax Human IL-7， Tag Free （Cat. No. IL7-H4219） stimulates proliferation of PHA-P-activated human peripheral blood mononuclear cell （PBMC）. The EC50 for this effect is 1.565 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）.
In the above ELISA analysis， three different lots of biotinylated hTNF-alpha （Cat. No. TNA-H82E3） were used detect immobilized Adalimumab （5ug/ml）. The result showed that the batch variation among the tested samples is negligible.
Recombinant Human TNF-alpha （Cat. No.TNA-H4211） induces cytotoxicity effect on the WEH1-13VAR cells in the presence of the metabolic inhibitor actinomycin D. The ED50 for this effect is 0.007-0.014ng/ml. The result shows that the batch variation among the tested samples is negligible.
The binding affinity between Herceptin and different batches of FcRn / FCGRT & B2M Heterodimer Protein （Cat. No. FCM-H5286） were determined by SPR assay. The result shows that the batch variation among the tested different lots is negligible.
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.
|Analytical Procedure||Test items||Source of procedures||Validation items|
|Lowry||Protein content||ICH Q2 (R1) and 9101 Guidelines for Validation of Analytical Procedures in Volume IV of ChP 2020||specificity, accuracy, precision, linearity, range and robustness|
|SDA-PAGE||Identity||ICH Q2 (R1) and 9101 Guidelines for Validation of Analytical Procedures in Volume IV of ChP 2020||specificity, accuracy, limit of detection (LOD), robustness|
|Endotoxins||Biological assay methods||Kinetic Chromogenic Assay in General Chapter 1143 Bacterial Endotoxins Test in Volume IV of ChP 2020||reliability test of standard curve, and interference test of test sample|
|Sterility||Biological assay methods||Sterility Test in General Chapter 1101 Microbiological Examination in Volume IV of ChP 2020||sensitivity test of culture medium, and method suitability test|
|Mycoplasma||Biological assay methods||ICH Q2 (R1) and 9101 Guidelines for Validation of Analytical Procedures in Volume IV of ChP 2020||specificity, accuracy, precision, limit of quantitation (LOQ), linearity, range and robustness|
|DNA residues||Impurity determination/ Quantification||ICH Q2 (R1) and 9101 Guidelines for Validation of Analytical Procedures in Volume IV of ChP 2020||specificity, accuracy, precision, limit of quantitation (LOQ), linearity, range and robustness|
|Cell Viability||Biological assay methods||9401 Guidelines for Biological Activity/Potency Assay Validation of Biological Products in Volume IV of ChP 2020||specificity, relative accuracy, intermediate precision, linearity, range|
|HCP Residues||Impurity determination/ Quantification||ICH Q2 (R1) and 9101Guidelines for Validation of Analytical Procedures in Volume IV of ChP 2020||specificity, accuracy, precision, limit of quantitation (LOQ), linearity, range and robustness|
|Kanamycin Residues||Impurity determination/ Quantification||ICH Q2 (R1) and 9101 Guidelines for Validation of Analytical Procedures in Volume IV of ChP 2020||specificity, accuracy, precision, limit of quantitation (LOQ), linearity, range and robustness|
Table 1. Example of the validation of cell viability analytical procedure
|Validation item||Validation criteria||Validation result||Validation conclusion|
Negative reaction, interference ≤ 20%.
average RSD = 5%
The relative bias should be within ± 12%.
The maximum bias was 6%.
The slope of regression equation should range from 0.80 to 1.25.
The slope was 1.11.
The geometric coefficient of variation (GCV, %) of relative potency of each potency level measured by different analysts on different dates should not be greater than 20%.
The correlation coefficient of linear regression equation should not be less than 0.95.
It should cover the range of potency quality standard of the product.
This method covered 64%–156% potency levels.
Table 2. Example of precision validation of the enzyme activity testing
|Test date||Number of detections||Measured value||Different analysts on the same day|
|Employee A, same analyst on different days|
|Employee B, same analyst on different days|
|Employee A, same-day repeatability|
|Employee B, same-day repeatability |
|Different analysts on different days|
|Premium Grade||GMP Grade|
|Application||Research and Development; Preclinical research and transition into clinical phases.||Designed to meet clinical phase requirements and bolster your IND application to various regulatory bodies. v|
|Quality System||ISO 9001 and 13485 Quality Management System||ISO 9001 and 13485 Quality Management System (R&D stage) including GMP Quality Management System (Production stage)|
|Production||ISO certified Workshop||GMP grade workshop certified by third-party audits|
|Transient, stable cell lines||Stable cell lines (Comprehensive external inspections)|
|Mostly animal-origin free materials||Animal-origin free materials|
|Pharmaceutical-grade materials||Pharmaceutical-grade materials|
|Strict secondary sterilization filtration||Strict secondary sterilization filtration|
|Laminar flow cleanroom with manual fill finish||B+A grade cleanrooms with automated fill finish|
|No specific virus removal or inactivation process||Specific virus removal / inactivation process (nanofiltration + low pH)|
|Quality Control||Sterility / Mycoplasma testing||Sterility / Mycoplasma testing|
|Endotoxin control and detection||Endotoxin control and detection|
|Validated key production equipment and analytical instruments||Strict verification, auditing, and tracking of all equipment and methods.|
|Process-related impurity testing (DNA, HCP, Residue)||Process-related impurity testing (DNA, HCP, Residue)|
|No additional quality control tests||Comprehensive virus residue testing, animal in vivo safety experiments|
|Documentation||Minimum documentation and certifications||Comprehensive regulatory support documentation|
|DMF files (Few products)||DMF files (All products)|
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