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| Customization: | Available |
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| Application: | Chemical Industry, Clinical Diagnosis, Cosmetics Industry, Food Industry, Food Safety, Pharmaceutical Industry |
| Main Material: | Stainless Steel |
| Shipping Cost: | Contact the supplier about freight and estimated delivery time. |
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The Marya Scale-Up Ready Formulation System accelerates biosimilar development with seamless transition from lab-scale (10mL) to commercial production (1000L+) while maintaining critical quality attributes (CQAs). This integrated platform combines high-precision tangential flow filtration (TFF) for protein concentration, AI-driven viscosity optimization (<20 cP for SC injection), and closed-system aseptic filling with <0.1% subvisible particle generation. Compliant with ICH Q5D/EMA biosimilar guidelines, it features real-time aggregation monitoring (via DLS and SEC-HPLC) and automated formulation buffer exchange, achieving >95% yield consistency across scales. Designed for monoclonal antibodies and insulin analogs, Marya reduces tech-transfer timelines by 50% with pre-validated scale-up protocols and GMP-ready documentation packages.
| Volume | 2~15000L |
| Material | 304,316L,904L,TA2 |
| Stirring type | Upper mechanical stirring, lower magnetic stirring |
| Stirring speed control accuracy | Speed range 0~450rpm |
| Temperature control accuracy | Temperature range-10~150ºC |
| Pressure control accuracy | Pressure range-0.01Mpa~0.06Mpa ±0.01MPa |
| Weighing control accuracy | 3‰ |
| Power supply | 380V 50Hz |
Why Choose Our Formulation System?
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