微流控纳米药物脂质纳米颗粒LNPs仪碰撞喷射混合器
碰撞喷射混合器IJM纳米药物制造LNPs
Lipid nanoparticles (LNPs) Impingement Jets Mixing Small Scale
德国/KNAUER
基于 mRNA 新冠病毒疫苗的研发,脂质纳米颗粒(LNPs)已经被证实是用来递送 RNA 药物、疫苗的有效载药方式。LNPs 封装包裹易降解活性成分,模拟低密度脂蛋白 (LDLs),由内源性途径摄取。LNPs 对 pH 值敏感,其设计目的是将其有效载荷释放到细胞质中。这将是接种疫苗历史上首次大规模使用核酸脂质纳米颗粒。
新的医学发展使药物及其活性成分日益复杂,并带来了新的挑战。例如,寡核苷酸很容易在人体内降解。zui新研究表明 LNPs 可以形成一个用来保护活性成分(如:RNA、mRNA、siRNA 或基于 DNA 的 API)的稳定环境。像核酸类药物和向靶细胞运送途径的优化是当下非常热门的研究领域。
总部位于德国柏林的高科技实验室仪器制造商 KNAUER,主要以液相色谱系统、SMB、连续流层析闻名。通过结合在高压加料和实验室系统工程方面的丰富经验,成功开发生产制药脂质纳米颗粒的合成设备 —— LNPs 制药生产装置。
详情介绍
KNAUER 的喷射混合技术在小规模和大规模的疫苗脂质纳米颗粒生产中表现出优异的性能。可为研发用户提供小型桌面设备,并为制药行业提供完整的 LNPs 装置。
LNPs 生产系统,也称为 IJM 设备(冲击喷射混合)经过设计和优化,满足客户性能要求及法规要求。并成功在洁净间(C 级)内进行了安装及验收。该系统预留了所有必须的接口,用于集成到客户自己的 PLC(可编程逻辑控制器)系统中。
不同型号的技术参数:
Pilot Scale Unit | Small Production Scale Unit | (Customized) Large Production Scale Units* | |
Number of impingement jets mixers | 1 | 2 | up to 8 |
Number of pumps | 4 | 8 | up to 16 |
Number of flow meters | 4 | 8 | up to 16 |
Number of valves | 1 | 2 | — |
Process connection inlet** | 1/2" Tri-clamp (4 inlets) | 3/8" and 1/4" barbed fitting (6 inlets) | Sanitary Clamp Connector (2 inlets) |
Process connection outlet** | 1/2" Tri-clamp (1 outlet) | 1/4" barbed fitting (2 outlets) | Sanitary Clamp Connector (1 outlet) |
Volumetric flow rate | up to 1 l/min | up to 2 l/min | depending on configuration |
Volumetric flow rate | up to 60 l/h | up to 120 l/h | depending on configuration |
Maximum operating pressure*** | 100 bar | 100 bar | 50?70 bar |
Liquid temperature range | 4?60 °C (39.2?140 °F) | 4?60 °C (39.2?140 °F) | 4?60 °C (39.2?140 °F) |
Wetted materials | stainless steel, PEEK, titanium, FFKM, PTFE (GFP 55), aluminum oxide, ruby, sapphire, EPDM | stainless steel, PEEK, titanium, FFKM, PTFE (GFP 55), aluminum oxide, ruby, sapphire | stainless steel, PEEK, titanium, FFKM, PTFE (GFP 55), aluminum oxide, ruby, sapphire, EPDM |
Software | CDS, 21 CFR part 11 compliant | CDS, 21 CFR part 11 compliant | not included, necessary interfaces for the integration into PLC |
Interfaces | pump: LAN, RS-232, pin header connectors; flow meter: RS-232 + FLOW- BUS™; valve drive: LAN | pump: LAN, RS-232, pin header connectors; flow meter: RS-232 + FLOW- BUS™; valve drive: LAN | pump: LAN, RS-232, pin header connectors; flow meter: RS-232 + industrial interfaces |
Power supply | pump: 100–240 V, 50–60 Hz; flow meter: +15…24 V DC, valve drive: 24 V DC | pump: 100–240 V, 50–60 Hz; flow meter: +15…24 V DC, valve drive: 24 V DC | pump: 100–240 V, 50–60 Hz; flow meter: +15…24 V DC |
Power consumption (per device) | pump: maximum 320 W; flow meter: 3 W; valve drive: 65 W | pump: maximum 320 W; flow meter: 3 W; valve drive: 65 W | pump: maximum 320 W; flow meter: 3 W |
Ambient conditions | temperature range: 4–40 °C; 39.2?104 °F; below 90 % humidity (non-condensing) | temperature range: 4–40 °C; 39.2?104 °F; below 90 % humidity (non-condensing) | temperature range: 4–40 °C; 39.2?104 °F; below 90 % humidity (non-condensing) |
Dimensions (W x H x D) | 900 x 915 x 700 mm | 1000 x 1290 x 700 mm | depending on configuration |
Net weight (approx.) | 150 kg | 250 kg | depending on configuration |
API-predilution and quenching | Yes | Yes | depending on configuration |
GMP-ready documentation | Yes | Yes | Yes |
Factory acceptance test | Yes | Yes | Yes |
Site acceptance test | Yes | Yes | Yes |
Purchase order lead time | about 3 months | about 3 months | minimum 5 months, depending on customer requirements |
深圳市富彻尔生物科技有限公司
地址:深圳市龙岗区横岗街道深华街1号林展财富大厦315室,广东省
客服:
销售:
手机:
邮箱:
官网:
1年
是
有
免费安装培训
保修期内1年一次
免费更换零件
信息确认后48小时内给出保修方案
相关产品