Low pH incubation and neutralization automatic adjusting system and method

Abstract

The invention discloses a low pH incubation and neutralization automatic adjusting system and method. The system comprises an incubator, a stirrer, a pH electrode, a pH transmitter, a data acquisitioncard, a single-chip microcomputer, a central control system, multiple pumps, multiple diaphragm valves, multiple solenoid valves and multiple relays, wherein each diaphragm valve is connected with one solenoid valve, each solenoid valve is connected with one relay, each relay is connected with the single-chip microcomputer, the incubator is equipped with the pH electrode and the stirrer, the pH electrode is connected with the pH transmitter, the pH transmitter is connected with the data acquisition card, and the central control system is connected with the single-chip microcomputer, the dataacquisition card and the stirrer. The system is advantaged in that the following effects can be achieved on the laboratory scale, including fully automatic low pH incubation and neutralization, fullyautomatic sample delivery, fully automatic system cleaning and storage, fast, accurate and stable pH adjustment, and real-time automatic recording of experimental data such as the incubation pH, the temperature and the stirring speed.

Description

technical field [0001] The invention relates to instruments and equipment in the field of biomedicine, in particular to an automatic adjustment system for the separation and purification of biological protein drugs. Background technique [0002] In the downstream purification process of biological protein drugs, regulations require at least two virus removal processes with different mechanisms to ensure product safety. Low pH incubation and neutralization is a commonly used unit operation for inactivating enveloped viroids. [0003] In the large-scale production of biopharmaceuticals, based on commercial systems such as DeltaV, the automatic control of the process can be realized through customization, but at the laboratory scale, there is no mature and commercial equipment or system, and it can only be controlled manually by experimenters. The operation is complete. [0004] Low pH incubation and neutralization usually act after Protein A affinity chromatography. With the...

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Problems solved by technology

[0006] (1) No specific implementation form is described;

[0007] (2) There is no temperature control function, and temperature, as a key parameter for virus inactivation, is not reflected in this unit;

[0008] (3) The preset parameters cannot be customized by the user;

[0009] (4) The mixing after liquid addition and the stabilization of pH need a process, and the purely pH-based feedback adjustment mode will cause hysteresis, which is prone to overshoot (that is, exceeding the set value);

[0010] (5) The control of the unit and the storage of data are based on the local, which cannot be effectively integrated and analyzed with the data of other parts of the process;

[0011] (6) The patent only describes the function of the sample adjustment part, and does not describe the input and output parts of the sample, nor does it clean the system and preserve the pH electrode, so the invention in this patent can only be used for batch One-time operation, not applicable to continuous process, nor fully automatic control

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