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> SAFENSURE Advanced Safety Testing Solution for Biologics
Endotoxin, mycoplasma, and sterility testing are essential elements of quality control in biologics manufacturing, serving a critical role in ensuring both regulatory compliance and patient safety.Endotoxins, which may originate from raw materials or the manufacturing environment, can trigger severe pyrogenic responses and compromise drug efficacy. The Recombinant Factor C (rFC) assay offers a highly sensitive, animal-free alternative to traditional LAL methods, using fluorescence-based detection for more accurate and consistent results.
SAFENSURE™ is a specialized safety testing solution brand developed by ACROBiosystems, aligned with major pharmacopeias, international biopharmaceutical regulations. Tailored for critical safety evaluations in biologics manufacturing workflows, SAFENSURE™ provides validated assay kits for the detection of endotoxins, mycoplasma, and sterility, helping ensure regulatory compliance and product safety throughout the biologic production process.
Stable and Reliable — Stringent batch testing and release, with inter-batch variability less than 15%.
Regulatory Compliance — Compliant with standards and regulations of international regulatory agencies.
Global Supply — Product delivery in 1-3 days, worldwide.
Comprehensive Validation — Referencing guidelines including ChP, Ph. Eur. and USP.
The recombinant Factor C (rFc) assay uses genetically engineered recombinant Factor C to bind and detect endotoxins with high sensitivity and specificity. Upon activation by endotoxin, the rFC cleaves a fluorogenic substrate, generating a fluorescence signal proportional to endotoxin levels.
Compared to conventional LAL assays, this kit provides improved accuracy, eliminates interference from Factor G pathways, and delivers more consistent, reproducible results aligned with global regulatory trends toward sustainability and animal-free testing.
Different methods were used to detect endotoxin residues in five samples, and the values of this rFc method and LAL method were at the same level.
The kit is applicable in endotoxin detection of injectable drugs and some medium, such as Recombinant Human Interferon α-1b, Human insulin injection and different mediums. The results of the rFc method of this kit are compared with those of LAL method.
The rFC method was employed to detect endotoxin residues in β-glucan at concentrations of 10ug/mL and 1ug/mL. No non-specific signals were detected. In contrast, the dynamic chromogenic method used for β-glucan detection resulted in the detection of endotoxin and non-specific signals. This indicates that recombinant factor C does not react with β-glucan, demonstrating the good specificity of the rFC method.
Using Endotoxin (USP, Cat. No. U1235503) as the standard, the recovery rate of ACRO Kit standard is in the range of 50%-200%, which meets the requirements.
Mycoplasma contamination poses a critical risk during biologics production, particularly in processes such as cell isolation, modification, and expansion. To ensure the safety of the final product, mycoplasma must be completely excluded during release testing. ACROBiosystems’ SAFENSURE™ offers a comprehensive mycoplasma analytical reagents, including Mycoplasma DNA Sample Preparation Kit and Mycoplasma Rapid Detection Kit, developed to meet the requirements of European Pharmacopoeia Chapter 2.6.7，accelerating both biologics in-process monitoring and batch release.
| Cat. No. | Description | Size |
|---|---|---|
| OPA-E101 | Mycoplasma DNA Sample Preparation Kit (Magnetic beads) | 50 Prep |
| OPA-S102 | Mycoplasma Rapid Detection Kit (qPCR) | 50 Tests |
| Number of Mollicutes detected with a Database match | |
|---|---|
| Genus | No. |
| Mycoplasma | ＞200 |
| Acholeplasma | 14 |
| Spiroplasma | 25 |
| Ureaplasma | 7 |
| ID | Mycoplasma Species | Compendia requirements (CFU/mL) | Results | Limit (CFU/mL) |
|---|---|---|---|---|
| 1 | Mycoplasma orale | 10 | 24/24 | 1 |
| 2 | Mycoplasma pneumoniae | 10 | 24/24 | 0.1 |
| 3 | Mycoplasma hyorhinis | 10 | 24/24 | 1 |
| 4 | Mycoplasma salivarium | 10 | 24/24 | 1 |
| 5 | Mycoplasma fermentans | 10 | 24/24 | 1 |
| 6 | Mycoplasma synoviae | 10 | 24/24 | 1 |
| 7 | Mycoplasma gallisepticum | 10 | 24/24 | 1 |
| 8 | Mycoplasma arginini | 10 | 24/24 | 1 |
| 9 | Acholeplasma laidlawii | 10 | 24/24 | 0.1 |
| 10 | Spiroplasma citri | 10 | 24/24 | 0.1 |
| Unrelated strain/Cell line | Ct Value | Result | |
|---|---|---|---|
| Streptococcus pneumoniae | Undetermined | Undetermined | 0/2 |
| Lactobacillus acidophilus | Undetermined | Undetermined | 0/2 |
| Staphylococcus epidermidis | Undetermined | Undetermined | 0/2 |
| Clostridium sporogenes | Undetermined | Undetermined | 0/2 |
| Clostridium acetobutylicum | Undetermined | Undetermined | 0/2 |
| CHO（106 cells/mL） | Undetermined | Undetermined | 0/2 |
| HEK293（106 cells/mL） | Undetermined | Undetermined | 0/2 |
| T cell（107 cells/mL） | Undetermined | Undetermined | 0/2 |
| Pichia pastoris | Undetermined | Undetermined | 0/2 |
| E.coli | Undetermined | Undetermined | 0/2 |
Flyer—Recombinant Factor C (rFc) Endotoxin Detection Kit
Datasheet—Recombinant Factor C (rFc) Endotoxin Detection Kit
Flyer—Mycoplasma DNA Sample Preparation / Detection Kits
Datasheet—Mycoplasma Rapid Detection Kit (qPCR)
resDetect™ CMC Manufacturing Process Residue Detection Solutions
E. coli resDNA Quantitative Kit (qPCR)
CHO resDNA Quantitation Kit (qPCR)
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