In the 2020 edition of the "Chinese Pharmacopoeia" - Chapter Three on Biological Products - "Preparation and Quality Control of Animal Cell Substrates for the Production and Testing of Biological Products," it is stated: "The establishment of a cell bank can provide cells that are qualified, of the same quality, and can sustain stable passages for the production of biological products." Therefore, safety and stability are always critical considerations when managing cell products in accordance with pharmaceutical standards in China. Continuous evaluation is required to ensure controlled product quality and batch consistency, covering aspects from the production of raw materials (cell banks), manufacturing process technology, formulation quality control, to the final formulation's uniformity and packaging integrity.

The previous article mentioned the challenges of manual, repetitive operations and prolonged exposure time during the filling of cell formulations. To save time in building libraries, improve the consistency of cells/products, reduce contamination risks, and save costs in quality control, this article will focus on an automated filling solution for "live" cell formulations in frozen storage tubes – Cytoniche's 3D FloTrix® vivaFILL Cryovial Filling System.

3D FloTrix® vivaFILL Cryovial Filling System can achieve various cell formulation and exosome formulation filling processes, ensuring the efficiency and quality of formulation production.

[Product Features]

Efficient and User-friendly

Achieve filling of 1000 tubes per hour with one machine.

◆Simultaneously automate the opening and closing of 16 tubes, 8-channel automated filling.

◆Built-in optical sensors for tight lid detection.

Image: Intelligent lid opening and closing module

2.Precision Filling

Filling volume accuracy error ≤ ±0.1 mL or ±5%.
◆Can be equipped with high-precision flow control peristaltic pump.
◆Coaxial control ensures uniform flow rates for eight-channel filling.

Maintain initial cell viability deviation ≤ 5%.

◆Low shear peristaltic pump ensures cell viability.

Image: High-precision filling system

3.High Compatibility

Flexible adaptation to various brands of frozen storage tubes.

◆Switch between 2 mL and 5 mL specifications of the same brand's frozen storage tubes, easily achieving 0.1 mL to 5 mL cell formulation filling.

Image: Adaptation of frozen storage tube styles

4.Flexible Configuration

◆Compact structure, easily placed in a biosafety cabinet.

◆Tolerant to conventional sterilization methods.

5.Safety and Convenience

◆Fully illustrated operation flowchart, reducing learning costs.

◆Software design compliant with 21 CFR Part 11 regulations and GAMP 5 guidelines, ensuring traceable and complete data.

[Application Data]

Through continuous monitoring of filling volumes and accuracy testing for different volumes, the accuracy error of cell formulation filling volumes can reach ≤ ±0.1 mL or ±5%.

By testing cell density in continuously filled cell samples and cell formulation filling with different volumes, the density deviation of cell formulation filling is RSD ≤ 10%.

The 3D FloTrix® vivaFILL Cryovial Filling System, with its efficient and stable characteristics, ensures the quality and batch consistency of cell formulation products. It contributes to the production preparation of cell therapy products and the "raw material" cell bank, laying a solid foundation for exploration in various research fields.

【CytoNiche】

CytoNiche was established in 2018, led by Professor Yanan Du's research team from the School of Medicine at Tsinghua University, with Tsinghua University as a shareholder. The core technology originated from the transformation of scientific achievements at Tsinghua University and was recognized as a leading technology in "Science and Technology Innovation in China" by the China Association for Science and Technology. As a national-level high-tech enterprise, a national-level specialized and new technology "Little Giant" enterprise, a potential unicorn enterprise, it has also received key research and development special support from the Ministry of Science and Technology.
As an expert in high-quality three-dimensional cell manufacturing, CytoNiche provides a one-stop customized solution for cell scale-up based on 3D microcarriers. The company has built an original 3D cell smart manufacturing platform, achieving large-scale, automated, intelligent, and closed-cell drug and derivative production preparation. This helps global customers establish the most advanced cell drug production lines. After pioneering the production process pipeline for "billion-level" stem cells, the company is accelerating towards "hundred billion-level," dedicating efforts to empower the cell and gene therapy industry with 3D cell scale-up smart manufacturing technology to benefit more patients.