分离纯化技术是生物制药过程的核心环节，为了生产高纯度、高活性的生物药物，传统的分离纯化技术远不能解决现代生物制药企业的技术需求；由于生物药结构的多样性以及监管部门对生物药的纯度要求越来越严格，生物制药对工艺的要求非常严谨苛刻，对材料的要求非常严格，使得生物药的分离纯化难度越来越大。因此，如何经济、高效的从复杂组分中浓缩、分离和纯化目标生物分子，往往是生物药生产的瓶颈。
Separation and purification technologies is the core part of pharmaceutical, biological drugs in order to produce high purity and high activity, the traditional purification technology can not solve technical requirements of modern biological pharmaceutical enterprises; due to the biological diversity and structure of the drug regulatory authorities of the purity of biological drugs increasingly stringent requirements, requirements for bio pharmaceutical technology very strict demanding, very strict requirements for materials, purification of more and more difficult to separate the biological drugs. Therefore, how to concentrate, separate and purify target biomolecules from complex components is often the bottleneck of biological drug production.
切向流过滤也叫错流过滤，是目前生物制药工艺中重要的分离纯化工艺。近年来，随着部分注射剂产品（单克隆抗体，疫苗，重组蛋白，血液制品等）对浓度要求的不断提高，生产成本和操作难度也逐渐增加。对于较大规模的料液过滤时，就要采用切向流过滤的方式，有利于降低综合成本，使高浓度浓缩工艺的实现成为可能。
Tangential flow filtering, also called flow filtration, is an important separation and purification process in biological pharmaceutical technology at present. In recent years, as part of the injection products (monoclonal antibodies, vaccines, recombinant proteins, blood products, etc.) continue to increase the concentration requirements, the production cost and operation difficulty also gradually increase. For larger scale material filtration, tangential flow filtration is adopted, which helps reduce the comprehensive cost and make the high concentration process possible.
切向流过滤的原理图。
A schematic diagram of a tangential flow filter.
切向流过滤属于压力过滤/膜过滤技术中的一种。在传统的死端过滤技术中，滤液的流动方向与滤膜垂直，与过滤方向一致，大部分小分子透过滤膜，而大分子聚集在膜的表面，随着时间的增加，膜面上堆积的颗粒也增加，过滤阻力增大，膜渗透速率下降。而在切向流过滤中，滤液的流动方向与滤膜平行，与过滤方向垂直，小部分小分子透过滤膜，大分子从膜的表面带走，随着时间的增加，膜面上堆积的颗粒物数量有限，不影响过滤的速度和效果。
Tangential flow filtration is one of the pressure filtration / membrane filtration technology. In the traditional dead end filtration technology, flow direction and vertical filtrate membrane, consistent with the direction of the filter, most of the small molecules through the membrane surface and molecular aggregation in the membrane, with the increase of time, the accumulation of film on the surface of the particles increases, filtration resistance increased, the membrane permeation rate decreased. In the tangential flow filtration, the filtrate and filter the flow direction parallel to the vertical direction and filtering, small part of small molecules through the membrane molecules from the membrane surface away, as time increases, the accumulation of particles on the membrane surface of a limited number, does not affect the speed and effect of filtering.
切向流过滤系统。
Tangential flow filter system.
切向流过滤技术常用于生物制品，血制品及疫苗的生产。美国芝加哥市的某DNA实验室采用切向流过滤系统，将金缀合抗体溶液进行浓缩收集，浓缩后浓度达到浓缩前的20倍。
The tangential flow filtration is often used in the production of biological products, blood products and vaccines. A DNA laboratory in Chicago, USA, used the tangential flow filtration system to concentrate and collect the gold conjugated antibody solution, and the concentration reached 20 times before the concentration.
美国芝加哥市的某DNA实验室搭建的金缀合抗体浓缩实验装置。
An experimental device for concentration of conjugated antibody was set up in a DNA laboratory in Chicago, USA.
该过滤浓缩系统使用了兰格公司的蠕动泵和配套产品，包括BT600-2J驱动器加装YZ2515X泵头、Pharmed 15#软管，来驱动滤液顺利通过过滤器，并提供跨膜压，使溶液中多余的水分子及其他小分子（无色透明）通过超滤膜，收集在锥形瓶中。而金缀合抗体（红色），因其分子量大，无法通过超滤膜，在蠕动泵的驱动下，回流至收集瓶中。金缀合抗体浓缩系统在泵送滤液时，要求：
The filtration and concentration system using Lange company peristaltic pump and ancillary products, including the BT600-2J driver with YZ2515X pump head, Pharmed 15# hose, to drive the filtrate smoothly through the filter, and the transmembrane pressure, the excess water molecules in solution and other small molecules (colorless) by ultrafiltration, collected in flasks. And the gold conjugate antibody (red), because of its large molecular weight, can not pass through the ultrafiltration membrane, under the drive of the peristaltic pump, reflux into the collecting bottle. The gold conjugate antibody concentration system in the pump filtrate requires:
保证生物分子的完整性和生物活性。
To ensure the integrity and biological activity of biomolecules.
泵送溶液流量：40 mL/min, 但随着浓缩的进行，溶液密度增加，需要根据压力表的指示，降低泵的转速和流量，以防止系统压力持续增高而超过过滤器可承受的压力。
The flow rate of pump solution is 40 mL/min, but with the concentration increasing, the density of solution increases. It is necessary to reduce the speed and flow of pump according to the indication of pressure gauge, so as to prevent the pressure of the system from increasing continuously and exceed the pressure that the filter can bear.
泵送系统可靠，在连续工作3-5小时内，不会出现漏液问题，以减小金缀合抗体的损失。
The pump system is reliable. Within 3-5 hours of continuous work, the problem of leakage will not appear to reduce the loss of conjugated antibody.
兰格公司生产的BT600-2J驱动器和YZ2515X泵头。
The BT600-2J driver and the YZ2515X pump head produced by Lange company.
兰格公司配套蠕动泵销售的Pharmed 15#软管。
Pharmed 15# hose sold by Langer company supporting peristaltic pump.
BT600-2J驱动器 + YZ2515X泵头 + Pharmed 15#软管的蠕动泵方案具有如下优势：
The BT600-2J driver + YZ2515X pump head + Pharmed 15# hose wriggle pump scheme has the following advantages:
兰格的蠕动泵具有低剪切力，在泵送生物活性物质时，可以保证生物分子的完整性和活性。
Langer's peristaltic pump has a low shear force, which can ensure the integrity and activity of biomolecules when pumping bioactive substances.
兰格的蠕动泵更换软管简单方便，在实验室中，传输不同溶液时，仅通过简单更换满足卫生等级的软管，即可避免不同溶液之间的交叉污染。
Lange's peristaltic pump replacement hose is simple and convenient. In laboratory, when transferring different solutions, it can avoid cross contamination between different solutions only by simply replacing the hose that meets the hygienic grade.
兰格的蠕动泵方案提供1.6 - 960 ml/min的流量范围。流量可手动调节，也可通过接收外部控制器发出的控制信号，实现过滤系统流量的自动调节，以保证系统压力在允许范围内。
Lange's peristaltic pump scheme provides a 1.6 - 960 ml/min flow range. The flow can be manually adjusted, and it can also automatically control the flow of the filtration system by receiving the control signals emitted by the external controller, so as to ensure the system pressure is within the allowable range.
兰格的蠕动泵的流量误差≤±2%，经过校正后的流量误差可以达到±0.5%。精准可控的流量，可维持切向流过滤系统的连续过滤，以达到预期的浓缩效果。
The error is not more than 2% peristaltic pump Lange, flow through the error correction can be achieved after 0.5%. The accurate and controllable flow can maintain continuous filtration of the tangential flow filter system to achieve the desired concentration effect.
兰格的Pharmed软管的耐腐蚀性和耐磨性俱佳，使用寿命>10000小时，在传输高价值溶液时，可最大程度的降低因软管破损而导致的漏液损失。
Lange's Pharmed hose has excellent corrosion resistance and abrasion resistance, and its service life is >10000 hours. When transporting high value solution, it can minimize the leakage loss caused by hose breakage.