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New Product Launch | Prologue: An Introduction to Cell Production and Preparation Process - Cell Formulation Packaging

New Product Launch | Prologue: An Introduction to Cell Production and Preparation Process - Cell Formulation Packaging

  • Categories:Company News
  • Author:CytoNiche
  • Origin:CytoNiche
  • Time of issue:2023-04-25
  • Views:36

(Summary description)As the final step in the cell production and preparation process, cell formulation packaging plays a crucial role. Any errors or mistakes in this step can undo all the previous efforts and lead to sig

New Product Launch | Prologue: An Introduction to Cell Production and Preparation Process - Cell Formulation Packaging

(Summary description)As the final step in the cell production and preparation process, cell formulation packaging plays a crucial role. Any errors or mistakes in this step can undo all the previous efforts and lead to sig

  • Categories:Company News
  • Author:CytoNiche
  • Origin:CytoNiche
  • Time of issue:2023-04-25
  • Views:36
Information

In recent years, there have been significant breakthroughs in the research of cell therapy for various diseases worldwide. This innovative treatment approach, which utilizes living cells, has shown tremendous potential in the treatment of cancer, diabetes, genetic disorders, and rare diseases, offering hope for cure to a larger number of patients. The success of cell therapy products is closely related to factors such as cell viability, quantity, safety, and stability. Therefore, it is crucial to study and focus on the development of stable and reliable production and preparation processes.

Image: Overview of the Cell Preparation Process

As the final step in the cell production and preparation process, formulation packaging is crucial for cell therapy products. Any mistakes in this step can undo all the previous work and lead to significant losses. Therefore, this 'last mile' is of utmost importance for the final cell therapy product. This article provides a brief overview of the technology and trends in cell formulation packaging.

 

[Manual Cell Product Packaging Method]

Cell products are manually packaged into cryovials.

Image: Manual Packaging - Main Steps of Bagging

 

Cellular formulation is packaged into cryovials.

Image: Scene of cellular formulation being packaged into cryovials.

Image: Main process of manual packaging - filling cryovials.

① In the ultra-clean table, open the cell suspension tube and add the freezing-storage solution, and the stock solution preparation is continuously exposed to grade A environment.

② Manually use the pipette gun to "blow" and mix.

③ Open the freeze-storage tube, pipetting, close the freeze-storage tube, complete the filling of one tube, and the subpackaged preparation is continuously exposed to the A-level environment.

 

[Drawbacks of Manual Cell Formulation]

Difficult Quality Control:

Limited capacity for single-person operation, making it challenging to achieve batch consistency in multi-person operations.

Unstable temperature control, leading to increased risk of cell damage due to inaccurate timing.

Manual mixing is inconsistent, resulting in compromised activity and uniformity of the cell suspension.

High Cost:

The process is labor-intensive and requires extensive manual operations and production records.

Prone to Contamination:

Prolonged and repeated exposure of the cell suspension and formulation during the manual process increases the risk of microbial contamination.

 

[Future Development Trends]

To ensure the quality of cell therapy products, the National Medical Products Administration (NMPA) of China released the "Guidelines for the Production Quality Management of Cell Therapy Products (Trial)" in October 2022. It recommends the adoption of continuous and closed production processes, the use of dedicated, product-specific, or disposable devices to minimize the risks of contamination and cross-contamination.

The image titled "Guidelines for the Production Quality Management of Cell Therapy Products (Trial)"

 

With the increasing vitality and rapid growth of the cell therapy industry, the demand for cell product manufacturing has also been growing rapidly. The continuous introduction of policies and regulations reflects the emphasis on the accuracy, consistency, reliability, and reproducibility of cell products, which will become a key influencing factor in obtaining approvals. Therefore, it is evident that fully enclosed and automated cell production preparation is the optimal solution in response to the current situation.

As a pioneer in cell therapy process development and a provider of mature comprehensive solutions, Cytoniche Biotech is launching the 3D FloTrix® vivaPACK Cell Filling System to address the challenges of high manufacturing costs, complex operations, difficult quality control, and high risks in the production of cell therapy end products. Stay tuned for more information.

 


If you have any questions or needs about this product, you can scan the code or call the hotline: 400-012-6688
We will ask technical experts to provide you with answers and help.

 



【CytoNiche】

Beijing CytoNiche Biotechnology Co., Ltd. was established by the research team of Professor Du Yanan from Tsinghua University School of Medicine, and was jointly established by Tsinghua University through equity participation. The core technologies were derived from the transformation of scientific and technological achievements of Tsinghua University. CytoNiche focuses on building an original 3D cell "smart manufacturing" platform, as well as providing overall solutions for the 3D microcarrier-based customized cell amplification process.

CytoNiche's core product, 3D TableTrix® Microcarrier, is an independent innovation and the first pharmaceutical excipient grade microcarrier that can be used for cell drug development. It has obtained the certificate of analysis from relevant authoritative institutions such as National Institutes for Food and Drug Control, and obtained 2 qualifications for pharmaceutical excipients from the National Medical Products Administration (CDE approval registration number: F20210000003, F20200000496). Moreover, the product has obtained the DMF qualification for pharmaceutical excipients from U.S. FDA (DMF: 35481). 

Products and services of CytoNiche can be widely used in the upstream process development of gene and cell therapy, extracellular vesicles, vaccines, and protein products. At the same time, it also has broad prospects for applications in the fields of regenerative medicine, organoids, and food technology (cell-cultured meat, etc.).

Our company has a R&D and transformation platform of 5,000 square meters, including a CDMO platform of more than 1,000 square meters, a GMP production platform of 4,000 square meters, and a new 1200 L microcarrier production line. The relevant technologies have obtained more than 100 patents and more than 30 articles about the technologies in international journals have been published. The core technology projects have obtained a number of national-level project support and applications.

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Copyright: Beijing CytoNiche Biotechnology Co., Ltd.
Copyright: Beijing CytoNiche Biotechnology Co., Ltd.