We provide process
development and cGMP manufacturing services for various oncolytic virus products including oncolytic
adenovirus, herpes simplex virus, vaccinia virus, and vesicular stomatitis virus and new castle
disease virus. Our flexible cGMP manufacturing platform can meet your manufacturing demands of
different scales.
1
Virus Seed Stock Construction
Virus seed stock construction, identification, and
stability studies for the oncolytic virus provided
2
Cell Bank Construction
Construction of primary, master, and working cell banks
for adherent or suspension cell culture
3
Process and Analytical Method Development
Upstream process development, downstream process
development, analytical method development, and formulation development
4
GMP Run - Upstream Process
Adherent or suspension cell culture with the developed
method for specific type of oncolytic virus
5
GMP Run - Downstream Process
Automated and fully enclosed purification process,
patented sterilization technology
6
Aseptic Fill and Finish
Aseptic isolator under automatic Class-A environment
7
Quality Control and Release
Quality control system in compliance with regulatory
requirements
8
Deliverables
Package including oncolytic virus product, seed bank,
Certificate of Analysis, batch production record, batch inspection record, and
relevant Chemistry Manufacturing and Control (CMC) dossier
Development and Manufacturing at Post-IND stage
1
Virus seed stock and
cell banks transfer
Virus seed stock 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 oncolytic virus 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
