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SAFENSURE™ Advanced Safety Testing Solution for Biologics

Biopharmaceutical safety testing is fundamental to ensuring product quality, patient safety, and regulatory compliance. As innovative biologics—including monoclonal antibodies, vaccines, cell therapies, and gene therapies—continue to advance, the industry demands higher standards for analytical sensitivity, testing efficiency, standardization, and method robustness. Conventional testing methods often struggle to meet the increasing demands for rapid turnaround, automation, and accelerated batch release. Next-generation testing technologies, such as recombinant reagents and nucleic acid amplification technology(NAT), offer enhanced sensitivity, testing efficiency, and strong alignment with regulatory requirements, providing efficient and reliable solutions for biopharmaceutical safety testing.

SAFENSURE™ is ACROBiosystems' dedicated brand for biopharmaceutical safety testing, providing reliable and regulatory-compliant solutions for critical safety quality control. Designed to support quality control across the biopharmaceutical lifecycle, SAFENSURE™ helps biopharmaceutical manufacturers improve testing efficiency, minimize quality risks, and strengthen quality assurance.

Built on internationally recognized pharmacopeial standards, including USP and EP, SAFENSURE™ integrates advanced technologies such as recombinant reagents and nucleic acid amplification technology (NAT) to provide reliable safety testing solutions. The portfolio supports quality control across R&D, process development, GMP manufacturing, and product release, addressing evolving safety testing needs with solutions for endotoxin, mycoplasma, sterility, and other critical safety testing applications.

Safety & Sustainability

Safe and reliable, eco-friendly, building a sustainable future

Regulatory Compliance

Aligned with global standards, supporting confident compliance

Accelerated Batch Release

Boost testing efficiency, accelerate your path to market

Endotoxin Detection Platform

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.

Product List

Cat. No.	Description	Size
RES-A056	SAFENSURE™ Recombinant Factor C Endotoxin Detection Kit	48/96 Tests
RES-A129	LER Sample Dilution Buffer	(15 mL×5 bottles )/box
RES-A127	Endotoxin-Free Glass Test Tubes	2×boxes, (5 pieces×20 package)/box

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

Recombinant Factor C method fully validated in accordance with EP <11.0><2.6.32>and USP<1225><86>.
High concordance with traditional LAL methods, third-party validation by Eurofins. Request Eurofins Validation Reports
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.
Mitigates LER Challenges: Provides a dedicated solution for low endotoxin recovery (LER)-prone samples.
Rigorous method validation: Comprehensively evaluated for specificity, sensitivity, precision, accuracy, and suitability.

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

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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 Detection Platform

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

Cat. No.	Description	Size
OPE-32S	Automated Nucleic Acid Extraction System	/
OPA-E101	SAFENSURE™ Mycoplasma DNA Sample Preparation Kit (Magnetic beads)	50 Prep
OPA-S102	SAFENSURE™ Mycoplasma Rapid Detection Kit (qPCR)	50 Tests
OPA-R026	Nuclease-Free Water	10mL x 10bottle
OPA-R013	96 V-Bottom Deep-well Plate	1 box
OPA-R014	8-Strip V-Bottom Tip Comb	1 box

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 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.
Request Eurofins Validation Reports

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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
1	Mycoplasma orale	10	24/24
2	Mycoplasma pneumoniae	10	24/24
3	Mycoplasma hyorhinis	10	24/24
4	Mycoplasma salivarium	10	24/24
5	Mycoplasma fermentans	10	24/24
6	Mycoplasma synoviae	10	24/24
7	Mycoplasma gallisepticum	10	24/24
8	Mycoplasma arginini	10	24/24
9	Acholeplasma laidlawii	10	24/24
10	Spiroplasma citri	10	24/24

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

Outstanding Performance with Proven Reliability.

High-quality assurance with superior performance compared to other company products

Sterility Detection Platform

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

Cat. No.	Description	Size
OPE-32S	Automated Nucleic Acid Extraction System	/
OPA-E102	SAFENSURE™ Sterility Sample Preparation Kit (Magnetic beads)	16 preps
OPA-S103	SAFENSURE™ Sterility Rapid Detection Kit (qPCR)	50 Tests
OPA-R026	Nuclease-Free Water	10mL x 10bottle
OPA-R013	96 V-Bottom Deep-well Plate	1 box
OPA-R014	8-Strip V-Bottom Tip Comb	1 box

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: Detection sensitivity of <100 CFU/mL, meeting regulatory standards.
Convenient Operation: Single-well format with all essential components included for efficient testing.
Reliable Results: Demonstrates consistent performance with culture-based methods.
High Quality: Manufactured in ISO 13485 standards for reliable performance.

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Validation Data

Detection sensitivity of <100 CFU/mL

Taxonomic Group	Validated Species	LOD(CFU/mL)	Positive Detection
Bacteria	Bacillus subtilis	100	24/24
	Bacteroides fragilis	100	24/24
	Burkholderia cepacia	100	24/24
	Clostridium sporogenes	100	24/24
	Cutibacterium acnes	100	24/24
	Escherichia coli	100	24/24
	Micrococcus luteus	100	24/24
	Pseudomonas aeruginosa	100	24/24
	Staphylococcus aureus	100	24/24
	Streptococcus pyogenes	100	24/24
Fungi	Aspergillus brasiliensis	100	24/24
	Aspergillus niger	100	24/24
	Candida albicans	100	24/24