Policy Boost for Cell and Gene Therapy, Rocking Bioreactors Help Accelerate Large-scale Production

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At the 5^th China Biologics CMC Conference, the National Medical Products Administration released a positive signal: it will continue to promote the reform of the review and approval system, improve the regulatory system, focus on clinical needs, and vigorously support the research and development of advanced therapies including cell therapy and gene therapy. At the same time, enterprises are encouraged to integrate into the international innovation chain and supply chain to promote high-quality industrial development.

In 2025, among the 56 innovative drugs approved for marketing in China, 18 are biological products. Against the background of the continuous release of policy dividends, the cell and gene therapy (CGT) industry has ushered in a golden period of development. However, in the process from laboratory research to large-scale production, the process scale-up is still a major challenge facing the industry.

BioLink Bioreactors: Help Break Through the Bottleneck of Cell Scale-up

Conventional cell expansion methods face multiple bottlenecks during scale-up, such as cell sensitivity to shear forces, insufficient supply of dissolved oxygen, difficult to control pollution risks, and decreased stability after process scale-up, which restrict products from going to clinic and market.

To this end, BioLink CytoLinX^® RW 10-200 L Single-use Rocking Systems brings innovative solutions. The system adopts a unique rocking design, which not only realizes efficient oxygen supply and uniform mixing, but also creates a mild, low shear force and high dissolved oxygen culture environment for cells. Compared with the conventional mixing vessels, it avoids the mechanical damage caused by impellers and bubbling, and is more conducive to maintain the good status of cells. Through the periodic fluctuation of the level of the culture medium, it is fully contacted with the oxygen introduced into the bag, and the oxygen required for cell growth is continuously and stably provided.

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Figures 1 and 2: BioLink CytoLinX^® RW 10-200 L Single-use Rocking Systems

Multiple Sizes Available

CytoLinX^®RW 10-200 L Single-use Rocking Systems are available in a variety of volumes, including 10 L, 20 L, and 50 L for 0.2-25 L culture volumes, and 100 L and 200 L for 10-100 L culture volumes.

Core Benefits of Matching Cell Culture Bags

BioLink can also provide supporting CytoLinX^® WB Single-use Cell Culture Bag, whose core advantages are reflected in superior design and flexibility. It is by no means a simple "bag", but a highly engineered culture platform. With excellent design and diversified configuration, it can fully support the whole process from research and development of cell and gene therapy to commercial production.

Figure 3: Schematic diagram of standard cell bag

Multiple Specifications Cover Full-cycle Applications

R&D and Process Development (such as 0.5 L, 1 L, 2 L): Small-size consumables have low cost and are very suitable for process optimization experiments such as culture medium screening, inoculation density, and rocking parameters.
Clinical Sample Production (e.g., 10 L, 25 L): Meet the number of cells required for phase Ⅰ/Ⅱ clinical trials, especially suitable for multi-batch and small-batch production mode in autologous therapy.
Commercial Manufacturing (e.g., 50 L, 100 L): Suitable for stable, large-scale cell expansion for allotherapy or large-scale autologous therapy needs.

Multiple Configurations Improve Process Flexibility

Standard Configuration: Equipped with basic ports such as liquid inlet, sampling, and aeration to meet basic training needs.
Integrated Sensor Port: Online sensors such as pH and DO (dissolved oxygen) pre-integrated in the bag enable real-time monitoring and feedback control of the culture process to ensure process consistency.
Unique Perfusion Configuration: Specially designed for high-density culture, built-in PES hydrophilic membrane with PET support layer. PES features low protein adsorption, excellent hydrophilicity and precise pore size distribution, which can effectively reduce the loss of key nutrients and maintain a stable culture environment; The natural hydrophilic properties also facilitate wetting, significantly reducing the risk of bubble generation and cell adhesion.

Conclusion

With the continuous empowerment of policies, China's cell therapy industry is ushering in unprecedented development opportunities. With its rocking systems and supporting single-use consumables, BioLink has built an efficient, safe, flexible and easy-to-scale upstream culture system. The rich specification selection realizes the seamless connection from R&D to production, and the diversified configuration scheme gives greater freedom in process development. In particular, the integration of perfusion function makes ultra-high density cell culture easy and feasible.

References

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