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Why Us

Core“hard strength”+ “soft strength” for accelerating the development process of CGT drugs

Experienced experts with over 10 years in GCT, ensuring timely support across the product lifecycle.
Efficient technology transfer with optimized process validation
State-of-the-art facilities with cGMP compliant quality systems
130+ process development projects, 230+ analytical methods developed.
High standard and comprehensive quality controls.
End-to-End regulatory support with guided navigation

Industrialize Your Products

Process Development: Efficient and Customized Process Development with BoardProduct Spectrum

• Upstream Process

• Downstream Process

• Analytical Development

• Process Validation

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cGMP Manufacturing: Flexible Large-Scale GMP Manufacturing Platform:

• End-to-End Offerings

• Pre-IND Services

• Post-IND Services

• Capacity for Global

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Cold Chain Logistic: Traceable Cold-Chain Logistics with Controllable Risk

• Preserve gene and cell therapy products integrity and ensure timely delivery within specified temperature ranges.

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Quality & Regulatory

International Compliant Quality Control System

De-risk Your Regulatory Pathway

Competitive compensation and benefits

We provide e-CTD ready CMC related documents writing and review for your submission

Analytical Development

GMP Devices

Stainless Steel 100 L Fermentation Tank

High automation, closed end-to-end process culture design.

The stainless steel fermentation system is extensively employed for the amplification and cultivation of microorganisms.Itentails automatic control of pH, dissolved oxygen, stirring, fed-batch, temperature, air, and oxygen to ensure an ideal growth environment for microorganisms and facilitate the expression of the target product. The tank body and tubing are fully enclosed, maintaining an aseptic state throughout the culturing process, making it suitable for use in a grade D environment.
Triple-tank stainless steel fermentation system

Accommodate multiple culture volumes, offer versatility and scalability for various production requirements.
Single-use Continuous Flow Centrifuge

Mitigate cross-contamination risks between different batches.

Enhanced recovery of the target product, with a maximum processing capacity of 240 L/h.

Unique closed design and gentle treatment effectively minimize cell lysis, prevent bubbling, and facilitate subsequent product processing.

Allows for flexible inter-product and inter-batch switching, reducing validation time and costs, and shortening inter-batch intervals.

Substantially reduces cell separation costs while ensuring the activity and high yield of biological products.

Mitigates production risks, suitable for use at various scales and across multiple batches.
Stainless steel ultrafiltration system

ideal for pilot-scale operations and industrial production processes.

Efficient particle, colloid, bacteria, pyrogen, and high-molecular-weight organic substance removal from aqueous solutions.

Easy assembly and operation: Simply connect the tangential-flow ultrafiltration device, pump, pressure gauge, and tubing fittings, then add the sample to the tank to begin operation.

Fast and efficient: Compared to dialysis, this system offers simpler assembly and faster processing speed. Additionally, it achieves higher concentration levels in a shorter period compared to centrifugal concentrating devices or stirring ultrafiltration devices.

Scalability: The construction materials and fluid path of theUFcassette allow laboratory-scale conditions to be applied to production-scale processes.
AKTA Ready

A single-use chromatography system equipped with 2 sets of flow paths, including the Low Flow Kit and High Flow Kit. The single-use system mitigates the risk of cross-contamination.
KR2i

A benchtop Tangential Flow Ultrafiltration (TFUF). Combined with adisposable flow path, it can concentrate and diafiltrate vectors in a biosafety cabinet to meet the project requirements in downstream purification
Fully sealed cell preparation in a Class C+A environment

Cellular products must be produced in an aseptic environment to ensure the sterility assurance level required for safe transfusion back to patients.

The isolator and incubator management system utilize the RTP (Rapid Transfer Port) device for aseptic docking, facilitating rapid and straightforward operation, enabling the seamless exchange of internal resources within a sealed, aseptic environment, meeting the requirements for spatial and temporal isolation in the production of cellular products.
Magnetic separation
Efficient gas-phase liquid nitrogen tank

The Biosafe smart intelligent control system integrates liquid level control and container monitoring functions, displaying container safety monitoring information throughout the entire process from warehouse entry to exit. The 8.8 inch color touch screen features vibrant colors and powerful functions.

The system maintains a low liquid nitrogen evaporation rate of 0.9% per day. It can be sustained for several days even after the liquid nitrogen level drops below the platform.

It has the capacity to accommodate 43,120 vials of 2 mL cryovials and 720 bags of 500 mL cryopreservation bags.

Equipped with a 3-tier authorization control mechanism, the recorded information meets the GMP FDA CRF 21 part 11 certification requirements..

Career and Culture

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