SAFENSURE™ Advanced Safety Testing Solution for Biologics

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.

Star Product—Recombinant Factor C (rFc) Endotoxin Detection Kit (Cat. No. RES-A056)

Fully validated Recombinant Factor C method (Ph. Eur. 11.0 and USP<1225> guidelines). USP<86> has officially recognized the Recombinant Factor C (rFC) assay for endotoxin detection.
High concordance with traditional LAL methods, third-party validation available.
Superior specificity: Effectively eliminates β-glucan interference.
High accuracy: Endotoxin standards traceable to USP Standard (Cat. No: 1235503).
Rapid results: Assay completion in under 2 hours.
Industry-leading sensitivity: Detects endotoxin from 0.005 - 5 EU/mL.
Excellent buffer compatibility for diverse assay systems.
Good inter batch consistency: Guaranteed by genetic recombination technology production.

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Validation Data

High Sensitivity: Endotoxin detection results comparable to traditional LAL methods.

Different methods were used to detect endotoxin residues in four 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.

High Specificity

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.

Standard Traceability

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.

Product List

Star Product — Mycoplasma Rapid Detection Kit (Cat. No. OPA-S102)

Broad Coverage: Covers over 250 Mollicutes species, including all listed in EP, USP, JP.
High Specificity: Target mycoplasma 16S rRNA with no cross-reactivity to other genera.
High Sensitivity: Meets or exceeds regulatory standards of 10 CFU/mL.
Strong Compatibility: Suitable for complex matrices like high cell density samples and 10% DMSO.
Easy to use: Single-well assay format with built-in UNG and controls. results in 3 hours.
Reliable performance: Results align with culture-based methods; third-party validated by Eurofins.
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Validation Data

Broad Coverage: Detects over 250 species of Mycoplasma and Spiroplasma.

Number of Mollicutes detected with a Database match
Genus	No.
Mycoplasma	＞200
Acholeplasma	14
Spiroplasma	25
Ureaplasma	7

High Sensitivity: Meets regulatory guideline standards with a detection limit of 10 CFU/mL.

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

High Specificity: Unaffected by unrelated cell types or microbial strains.

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

High-quality assurance with superior performance compared to other competing products.

Nucleic Acid Testing (NAT) is a powerful approach for microbial detection, offering greater sensitivity and faster results than traditional culture methods. Validated to EP 2.6.1 and USP <71>, SAFENSURE™ Sterility Rapid Detection Kit (qPCR) delivers reliable test results in just 3 hours, enables simultaneous bacteria and fungi testing—revolutionizing in-process and lot-release testing with speed and reliability.

Paired with the SAFENSURE™ Sterility Sample Preparation Kit, the kits provide an end-to-end workflow from microbial nucleic acid isolation to detection. This minimizes handling errors, simplifies operations, and accelerates sterility testing with accurate, compliant results at lower cost.

Product List

Star Product — Sterility Rapid Detection Kit (Cat. No. OPA-S103)

Broad Coverage: Detects diverse microbial species, including specified in EP, USP, and ChP.
Dual Detection: Identifies bacteria and fungi in one test, simplifying sterility testing workflows.
Strong Specificity: Multiple primers and probes ensure no cross-reactivity with related strains.
High Sensitivity: Detects as low as 100 CFU/mL, fully compliant with or exceeding regulatory standards
Convenient Operation: Single-well format with all essential components included for efficient testing.
Comparable Results: Delivers results equivalent to traditional culture-based methods.
High Quality: Manufactured in a GMP-like facility under ISO 13485 standards for reliable performance.

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Validation Data

High Sensitivity

Strain Species	Limit (CFU/mL)	Results
Bacillus spizizenii	100	10/10
Burkholderia cepacia	100	10/10
Clostridium sporogenes	100	10/10
Cutibacterium acnes	100	10/10
Escherichia coli	100	10/10
Micrococcus luteus	100	10/10
Pseudomonas aeruginosa	100	10/10
Staphylococcus aureus	100	10/10
Streptococcus pyogenes	100	10/10
Candida albicans	100	10/10
Aspergillus brasiliensis	100	10/10
Aspergillus niger	100	10/10

High Specificity

The three fluorescent channels are independent and show no crosstalk, with a precision CV ≤ 0.25% (n=10).

Competitive Analysis

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)

DNase Activity Assay Kit

T7 RNA polymerase ELISA Kit

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