With process development and cGMP manufacturing services for viral vectors including adeno-associated virus and lentivirus, we can flexibly adjust to adherent or suspension-based platform to meet your manufacturing demands.
Development and Manufacturing at Post-IND stage
1
Bank Transfer
Cell bank transfer, gap analysis, and
technology
transfer report
2
Process Transfer
and Scale-up
Project-related process transfer; or
further process
scaling-up
3
Process
Validation and Optimization
Project-related process validation and
optimization your
process based on critical process parameters and
critical quality attributes
4
GMP Run
Large-scale cGMP manufacturing based on
qualified
process protocol
5
Aseptic Fill and
Finish
Aseptic isolator under automatic class-A
environment
6
Quality Control
and Release
Whole process quality control and
regulatory compliance,
releasing and delivery of qualified products
7
Deliverables
Package including viral vector product,
Certificate of
Analysis, batch production record, batch inspection
record, etc.
10+ years of dedication to gene and cell therapy
130 process development projects 230 analytical methods developed
Quality-driven team of experts with in-time responding
Efficient technology transfer with optimizing process validation
Process development versatility for various product needs stages
End-to-end regulatory support with side-by-side navigation
