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招聘公众号
生物工艺号
内毒素检测、支原体检测和无菌检测是生物药质量控制的核心环节，直接关系到产品合规性和用药安全性。内毒素来源广泛，一旦污染，可能引发热原反应并影响药物疗效。新一代检测方式基于重组C因子技术，通过荧光信号定量测定内毒素含量，具有高效、灵敏的优势。支原体和无菌快速检测以核酸扩增技术（NAT）为核心。支原体污染会影响细胞培养状态，干扰基因表达，甚至引发免疫反应。通过NAT技术，可在细胞培养过程中实现即时监测支原体，适用于细胞治疗和基因治疗等产品的快速放行。传统无菌检测方法（如经典微生物培养法）通常需要14天，检测周期长，影响生产效率。相比之下，基于qPCR的快速支原体及无菌检测可显著缩短检测时间，提升效率，同时降低污染风险。以上三项关键检测对于确保生物药生产的安全性、降低患者风险、提升企业市场竞争力具有重要意义，同时满足全球GMP法规对关键质量控制节点的严格要求。
SAFENSURE™ 是ACROBiosystems百普赛斯推出的专注于生物药安全性指标检测的品牌，符合各国药典和国际生物制药监管要求，专为生物制药生产过程中的关键质量控制环节而开发。SAFENSURE™系列涵盖内毒素、支原体及无菌检测试剂盒，广泛适用于生物药原材料、中间体及成品的安全性评估，助力生物药合规生产与质量保障。
稳定性高、一致性强 —— 严格批检放行，批间差异小于15%
符合监管标准 —— 支持申报，满足中美法规及监管机构要求
全球快速供应 —— 全球供应体系1-3天送达
全面系统验证 —— 参考ChP、USP、EP等药典，验证充分
重组C因子（recombinant Factor C, rFc）法是基于基因工程技术生产的重组蛋白C因子进行内毒素检测的方法，具有高灵敏度和高特异性。rFc与样品中的内毒素结合后，其酶活性被激活，可切割特定的荧光底物，产生与内毒素含量成正比的荧光信号，从而实现内毒素的定量检测。
相比传统的鲎试剂法（LAL），rFc法不受因子G通路的干扰，可有效避免β-1,3-葡聚糖引起的假阳性结果，具有更高的检测稳定性和重复性。此外，该方法不依赖动物资源，符合当前全球生物制药领域可持续发展和无动物源检测的监管趋势，正逐步成为内毒素检测的新标准。
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.
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.
在生物药的生产过程中，支原体（Mycoplasma）污染是影响产品安全性和合规性的重大安全隐患，尤其在细胞分离、修饰和扩增等关键环节。为确保最终产品的质量与安全，生物药放行检测中必须确保无支原体污染。ACROBiosystems推出的SAFENSURE™提供覆盖全流程的支原体检测解决方案，涵盖自动化核酸提取系统、支原体DNA提取试剂盒和支原体快速检测试剂盒，符合《欧洲药典》2.6.7章节的相关要求，助力生物药生产过程中的支原体实时监测及终产品的快速放行。
SAFENSURE™支原体快速检测试剂盒基于qPCR技术开发，具备高灵敏度和高可靠性，检测限低至10 CFU/mL，满足或优于国际监管指南的要求。相比传统培养法，该方法显著缩短支原体检测周期，检测更为简便，最快3小时内获得结果，显著提升检测效率。
| Cat. No. | Description | Size |
|---|---|---|
| OPE-32S | Automated Nucleic Acid Extraction System | / |
| 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 |
核酸检测（Nucleic Acid Testing, NAT）作为一种先进的微生物检测技术，相较于传统培养方法，具备更高的灵敏度和更快的检测速度。SAFENSURE™无菌快速检测试剂盒（qPCR）经EP 2.6.1和USP <71>方法学验证，能够在约3小时内提供可靠结果，并支持细菌与真菌的同步检测，为生物药过程监测与批次放行提供高效、合规的检测方案。
配合SAFENSURE™ 无菌样本制备试剂盒使用，可覆盖从微生物核酸提取到检测的完整流程，进一步降低操作复杂性、减少潜在误差，并提升检测结果的准确性与一致性。
| Cat. No. | Description | Size |
|---|---|---|
| OPA-E102 | SAFENSURE™ Sterility Sample Preparation Kit (Magnetic beads) | 16 preps |
| OPA-S103 | SAFENSURE™ Sterility Rapid Detection Kit (qPCR) | 50 Tests |
| 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 |
The three fluorescent channels are independent and show no crosstalk, with a precision CV ≤ 0.25% (n=10).
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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