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Contract Development and Manufacturing (CDMO)
ENCell Co. Ltd.’s CDMO
Multi-product GMP Production Technology-based CDMO Services
ROCKET(RObusting Customer’s Knowledge & IP through ENCell GMP Technology)platform
- 1. Excellent Quality Control and Stability
- Provides exceptional quality management systems and stability in the cell and gene therapy CDMO sector.
- Delivers the highest quality to customers through robust quality assurance systems.
- Ensures safety and reliability by meeting regulatory requirements.
- 2. Outstanding expertise and technical capabilities
- Uses cutting-edge technologies and advanced equipment to develop and manufacture a variety of drug products
(GMP-based facilities specializing in cell and gene therapies and viral vector treatments). - Pursue continuous research and innovation by experts.
- Supports customers with up-to-date knowledge and expertise on industry trends.
- 3. Customer-centric collaboration and flexibility
- Provides customized solutions to meet customer needs
(end-to-end pharmaceutical development services available). - Contributes to customer project success and business growth.
- 4. Extensive track record and experience
- Successfully completed multiple customer projects
(Clinical grade therapeutics manufacturing). - Works with global pharmaceutical companies.
Comprehensive consulting services for every stage from R&D to regulatory approval
- Providing services that meet regulatory requirementsHuman cell management, advanced biopharmaceutical manufacturing and cell processing facilities
- Research & Development
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Discovery of material candidates
Core manufacturing process development
Proof of Concept (POC) studies (in vitro, in vivo)
- Process Development
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Process development for clinical trial material manufacturing
New formulation development
Process optimization (QbD-based)
Characterization and Analytical Methods
- GMP manufacturing
and storage
-
GMP technology transfer
Validation of manufacturing and assay methods
Cell bank manufacturing and storage (MCB, WCB)
DS/DP manufacturing and storage
- Testing & Verification
-
Safety & Security
Stability testing
Toxicity and biodistribution studies (in vitro, in vivo)
Efficacy testing (in vitro, in vivo)
Logistics Services
- Regulatory support
-
Regulatory engagement support
CMC strategic consulting
IND filing support
Orphan Drug and Fast Track designation support
Technical Research for CDMO Process and Quality Analysis
- End-to-end services for advanced biopharmaceuticals
GMP manufacturing
process development
for cell and gene therapy
GMP quality
analysis development
for cell and gene therapy
Process optimization
and establishment of
key process standards
GMP technology
transfer
Viral targeting & production
platform development
Viral vector
systems development
Process
Customer Inquiry
NDA agreement
Scope Discussion
Cost Estimate
Contract Signing
Technology Transfer
Development &
Pilot Production
Product Manufacturing
& Quality Testing
Product launch