Is your drug development delayed by production bottlenecks?

High failure rate of technology transfer: only 67% of the transfer success rate from preclinical to clinical stage (2024 industry data)

Production scale cannot be matched: the demand for production capacity from Phase I to Phase III has surged by 500%, and the traditional model cannot cope with it

Compliance risks have increased: the number of FDA warning letters on CMC changes has increased by 43% year-on-year

Supply chain instability: the delivery delay rate of key materials (such as cell culture media) is ≥38%

End-to-end solution from preclinical to commercial production

Preclinical production: MiniPilot™ small-scale production system, batch switching time <2 hours, support IND application

Clinical production: FlexFactory™ modular production line, Phase I-III parallel production, flexible capacity expansion of 300%

Commercial production: Continuous Manufacturing Hub, production cost reduction of 25%, annual capacity ≥10,000L

Technology transfer: QbD-driven process scale-up model, 100% transfer success rate, PPQ batch pass at one time

Why choose us

1. Preclinical production: small scale, high efficiency

MiniPilot™ system: supports 50L-200L scale, meets IND application requirements

Quick release: QC testing cycle is shortened to 7 days (industry average 14 days)

Case: The IND approval time for a gene therapy project is shortened to 6 months

2. Clinical production: modular, flexible expansion

FlexFactory™ platform: supports Phase I-III parallel production, reducing technology transfer risks

​Intelligent monitoring: real-time tracking of key process parameters (CPP) to ensure batch consistency

​Data support: compared with the traditional model, the capacity utilization rate increased by 45%

​3. Commercial production: continuous, cost reduction and efficiency improvement

​Continuous flow technology: reduce batch switching time, and increase annual production capacity to 10,000L+

​Cost comparison: Monoclonal antibody project production cost 18/g (industry average 26/g)

​Compliance guarantee: zero FDA 483 observation items for 4 consecutive years

​3 major pitfalls that must be avoided from preclinical to commercial production

​1. Failure of technology transfer

​Must require: at least 3 similar projects’ transfer success rate data

​Our solution: QbD design space locked, transfer success rate 100%

​2. Insufficient capacity planning

​Beware: Phase I to Phase III capacity demand surges by 500%

​Our guarantee: modular production line, support rapid expansion

​3. Supply chain disruption crisis

Must verify: dual supplier strategy for key materials (such as cell culture medium)

Our advantage: Establish strategic reserves with Cytiva and Pall to ensure 6 months of emergency supply