A non-reducing disaccharide lyoprotectant with no Maillard reactivity toward proteins. It protects proteins, lipids and cell membranes during lyophilisation, freeze–thaw and storage — with low endotoxin and injectable-grade microbial control.
非还原性二糖冻干保护剂，不与蛋白发生美拉德反应。在冻干、冻融与贮存过程中保护蛋白、脂质与细胞膜，具备低内毒素与注射级微生物控制。
| Chemical name化学名称 | α-D-Glucopyranosyl-α-D-glucopyranoside dihydrate二水合物 |
| Formula / MW分子式 / 分子量 | C₁₂H₂₂O₁₁·2H₂O / 378.33 |
| CAS No. | 6138-23-4 (dihydrate)（二水合物） |
| Function功能 | Non-reducing disaccharide — no Maillard reaction with proteins. Protects proteins, lipids and cell membranes during lyophilisation, freeze–thaw and storage. 非还原性二糖，不与蛋白发生美拉德反应。在冻干、冻融与贮存过程中保护蛋白、脂质与细胞膜。 |
| Appearance性状 | White crystalline powder白色结晶性粉末 |
| Solubility溶解性 | Freely soluble in water (approximately 689 g/L)易溶于水（约 689 g/L） |
| Standards质量标准 | Compliant with current USP-NF / EP / JP / ChP符合现行 USP-NF / EP / JP / ChP |
| Grade级别 | Injectable grade, high purity and low endotoxin注射级，高纯度、低内毒素 |
In monoclonal antibody solutions, trehalose exhibits a significantly larger molecular volume (approximately 2.5× that of sucrose), conferring a stronger preferential hydration effect. Equivalent conformational stabilisation is therefore achievable at markedly lower concentrations.
在单抗溶液中，海藻糖的分子体积显著更大（约为蔗糖的 2.5 倍），优先水化效应更强，因此在明显更低的浓度下即可实现等效的构象稳定。
In lyophilised formulations it provides a high glass transition temperature (approximately 120 °C, versus approximately 70 °C for sucrose) together with exceptional thermal and acid stability — stable at pH 2 and 100 °C for 24 hours.
在冻干处方中提供高玻璃化转变温度（约 120 ℃，蔗糖约 70 ℃），并具有优异的热稳定性与耐酸性 —— 在 pH 2、100 ℃ 条件下 24 小时稳定。
Publicly documented examples of trehalose use in commercial biologics — the reason the injectable grade is specified so tightly.
海藻糖在商业化生物制品中的公开应用案例 —— 这也是注射级标准如此严格的原因。
| Product产品 | Active substance · company活性成分 · 企业 | Presentation剂型 |
|---|---|---|
| Ocrevus | Ocrelizumab · Roche | IV concentrate + SC静脉浓缩液 + 皮下注射 |
| Cosentyx | Secukinumab · Novartis | SC pen / PFS + IV皮下注射笔 / 预充针 + 静脉 |
| Herceptin | Trastuzumab · Roche | Lyophilised powder + SC冻干粉针 + 皮下注射 |
| Avastin | Bevacizumab · Roche | IV concentrate · 6% trehalose静脉浓缩液 · 含 6% 海藻糖 |
Product names and companies are referenced for illustration of trehalose use in marketed biologics. Trademarks belong to their respective owners; no affiliation or endorsement is implied.
以上产品与企业名称仅用于说明海藻糖在已上市生物制品中的应用。商标归各自权利人所有，不代表任何关联或背书关系。
High purity and low endotoxin. Typical specification shown; a CoA is provided for every batch.
高纯度、低内毒素。下表为典型规格，每批均提供 CoA。
| Test检测项目 | Typical specification典型规格 | Reference依据 |
|---|---|---|
| Appearance性状 | White crystalline powder; clear and colourless in solution白色结晶性粉末；溶液澄清无色 | ChP / USP-NF / EP / JP |
| Assay (HPLC, anhydrous basis)含量（HPLC，无水基） | NLT 99.0% | ChP / USP-NF / EP / JP |
| Water content (Karl Fischer)水分（卡尔费休法） | 9.0% – 11.0% | ChP / USP-NF / EP / JP |
| Specific optical rotation比旋度 | +197° ~ +201° | ChP / USP-NF / EP / JP |
| pH (100 mg/mL solution)（100 mg/mL 溶液） | 4.5 – 6.5 | ChP / USP-NF / EP / JP |
| Related substances有关物质 | Glucose, maltotriose and other polysaccharides tightly controlled葡萄糖、麦芽三糖及其他多糖严格控制 | ChP / USP-NF / EP / JP |
| Bacterial endotoxin细菌内毒素 | < 2.5 IU/g (ultra-low level available on request)（可依需求提供超低内毒素规格） | Injectable-grade control注射级控制 |
| Microbial limits微生物限度 | TAMC ≤ 100 cfu/g; TYMC ≤ 10 cfu/g; absence of E. coli and Salmonella 需氧菌总数 ≤ 100 cfu/g；霉菌酵母菌总数 ≤ 10 cfu/g；不得检出大肠埃希菌与沙门菌 | Injectable-grade control注射级控制 |
Ready for biologics formulation development and commercial supply. CoA and batch-to-batch consistency data provided.
可用于生物制品处方开发与商业化供应。提供 CoA 与批间一致性数据。
The manufacturer is registered with NMPA for this product.
该产品生产企业已在 NMPA 完成注册。
China DMF filed, supporting your formulation registration.
已递交中国 DMF，可支持贵司制剂注册。
Site audit welcomed, with full traceability of batch records.
欢迎现场审计，批记录可完整追溯。
Complete regulatory documents, including GMO-free, Halal and Kosher declarations for the relevant markets.
完整法规文件，含面向相关市场的无转基因、Halal 与 Kosher 声明。
Send the protein concentration, the buffer system and the market. We will come back with the grade, the ultra-low endotoxin option and the documents the filing needs.
把蛋白浓度、缓冲体系与目标市场发给我们。我们会回复适用规格、超低内毒素选项与注册所需文件。
