In the field of biopharmaceuticals, tangential flow filtration is widely used. Both hollow fiber filters and ultrafiltration membrane cassettes need to be used with a matching system. Common systems include automatic and manual systems. Among them, the manual tangential flow ultrafiltration system is composed of components such as pumps, balances, pressure gauges, filters, valves, and pipelines. Although it can achieve simple tangential flow process operations, it cannot record real-time data, nor can it perform constant flow and constant pressure control. Once the system is started, experimental personnel need to manually adjust the system pressure continuously, which is time-consuming and laborious.

In order to solve the process pain points of users operating the system manually, Cobetter has independently developed and launched the automated tangential-flow ultrafiltration system - TFF Minilab system.

The TFF Minilab system is an automated ultrafiltration system that can perform constant flow and constant pressure control, record real-time data, and generate curve graphs, enabling human-machine interaction. The data processing software of this system integrates functions such as manual/automatic mode switching, recipe setting, data collection, line graph reports, and audit trails. The 10 built-in process recipes can not only optimize the experimental process, but also make the operation simple and fast due to its user-friendly design. Compared with the manual tangential flow system, the Minilab system can effectively reduce labor costs and improve work efficiency.

Application Scenarios of TFF Minilab Ultrafiltration System

The TFF Minilab ultrafiltration system is mainly used for testing in combination with tangential - flow filters. Therefore, it is compatible with any field where membrane cassettes or hollow - fiber columns can be applied for testing. It mainly includes the concentration, diafiltration (buffer exchange), purification, and clarification of biological products such as antibodies, recombinant proteins, mRNA, nucleic acids, and viral vectors. In the CGT process, the TFF Minilab ultrafiltration system can assist in the concentration/diafiltration and buffer exchange process (as shown in the following figure).

In the complex CGT production process, multiple TFF (tangential - flow filtration) operations are involved (including bacterial collection, lysis and clarification filtration, mRNA concentration and buffer exchange, LNP concentration and buffer exchange, etc.). During the TFF process, changes in various internal parameters (such as concentration multiple, shear force, pressure, etc.) may directly affect the stability of intermediate products. Once there are problems with intermediate products, it will directly affect the yield and quality of the final products. Precise parameter control plays a crucial role in the stable production of CGT. In addition, during the process development stage, a large amount of real - time and authentic experimental data need to be retained as the basis for the feasibility of the production process.

The TFF Minilab system, with its precise parameter control, data collection, line graph reporting, and audit - trail functions, can effectively contribute to the development and optimization of CGT processes.

Application Case Sharing

Case 1:

Experimental Background: The target plasmid (6KD) needs to be concentrated, diafiltered and collected;
Experimental Materials + Equipment: 100KD hollow - fiber column + TFF Minilab system;
Process Parameters: Loading capacity 50L/m2; TMP: 10psi; Shear force: 6000/s; VCF: 10 - fold; VDF: 5 - fold;
Experimental Results: The average process flux is 21 LMH, and the target product yield reaches 97%.

Case 2:

Experimental Background: Exosome (LNP) concentration and diafiltration, particle size distribution (30 - 150nm);
Model Selection: 300KD hollow - fiber column + TFF Minilab system;
Process Parameters: Loading capacity 36L/m2; TMP: 2.5psi; Shear force: 2500/s; VCF: 9 - fold; VDF: 3 - fold;
Experimental Results: The average process flux is 26.2 LMH, and the target product yield reaches 101%.

Functional Advantages of the TFF Minilab System

Precise Pressure Control

The PCV valve of the system adjusts the internal pressure of the system in real - time according to the set value, and the pressure accuracy can reach ±2% - ±3%.

Real-time Data Collection

The system records relevant data in real - time, including weight, flow rate, pressure, loading capacity, process flux, shear rate, etc.

Real-time Curve Plotting

The system plots curves in real - time according to the collected experimental data, allowing users to better observe the operation trends of various parameters.

In summary, Cobetter Minilab automated TFF system brings the advantages such as simplicity and smoothness in operation logic and interface. Its precise pressure control also makes automated operations more reassuring. The real - time data recording can also provide a basis for your process development and optimization process, ensuring the integrity of process records while improving work efficiency. Feel free to contact Cobetter for sample trial.