LKtime possesses a fully-equipped cell culture process development platform and a professional technical team, specializing in cell culture process development, optimization and scale-up. The platform can rapidly achieve expression enhancement and quality optimization through multiple rounds of experiments leveraging its advanced technology, equipment and robust file system. Quality management and risk assessment concepts are implemented throughout the entire process, adhering to filing standards. 

- Media screening: According to the requirements of different projects, appropriate culture media and feed materials are selected for further screening and optimization. Meanwhile, the fed-batch strategies are evaluated.

- Process parameter optimization: Utilizing DOE/OFAT experimental design combined with statistical analysis to determine potential KPP and CPP, optimized process parameters set points and operating space are obtained.

- Quality control: Improve the expression level, monitor quality parameters throughout the process, and optimize quality parameters (acid-base peak ratio, G0F/G1F, sialic acid content, etc.) according to project requirements.

- Process confirmation and scale-up: Performing process confirmation to ensure the repeatability and robustness; then carrying out the process scale-up, and making appropriate adjustments to scale-dependent parameters based on equal P/V or Kla.

- Risk assessment: Combing multi-faceted information and using scientific tools (FMEA, RRF, C&E matrix, etc.), potential CQA and CPP are evaluated from multiple dimensions.

- Scale-down model validation: Using the TOST (equivalence test) approach to compare multi-batch scale-down data with pilot production data.

- Experimental design and evaluation: Conducting DOE/OFAT, characterizing the operating range and correlation of each process parameter based on risk assessment results.

- Establish control strategies for each unit and overall: Establishing control strategies for each unit and overall based on the characterized experimental results.