Contact US
+86 18721174739
jiyebio@jeyoupharma.com
A single-cell clone with expression levels exceeding 6 g/L could be obtained within 3 months, and the establishment of the primary cell bank could be completed within 4 months.
A compliant and mature commercial cell line development platform could ensure optimal CMC developability and guarantee commercial benefits.
Single Cell Imager
Flow Cytometer
Cell Freezing and Dispensing
Pipetting Workstation
Process Characterization & Validation:
Purpose:
Refers to the collection and evaluation of data from process design to commercial production, so as to demonstrate that the process can produce products consistently and comply with quality standards.
As a leading CDMO partner, we provide comprehensive analytical method development services for biological drugs. By our experienced scientific team and laboratories compliant with cGMP/GLP standards, we can develop HPLC/UPLC, CE, Marius and bioassay methods for clients, ensuring the specificity, sensitivity, and robustness of the methods.
We specialize in forced degradation studies, stability-indicating methods, impurity identification and quantification, supporting your drugs from early-stage R&D to commercialization. By optimizing the method development process through the QbD (Quality by Design) approach, we ensure data reliability and compliance, accelerating your IND/NDA/BLA submissions.
