CDMO
A leading supplier of biologics in the Asia-Pacific Region
CDMO
With two PIC/S GMP-certified manufacturing plants, Adimmune offers two platforms: embryo egg-based and cell culture-based. Our annual capacity is up to 100 million doses. All the manufacturing processes and the state-of-the-art environment are compliant with regulatory standards
2
PIC/S GMP-certified manufacturing plants
2
technology platforms
100M
doses annually
Drug Substance
- Cell culture-based platform
- Embryo egg-based expression system
Certificate
Taiwan FDA PIC/S GMP
Equipment
Stainless steel, single-use bioreactors ranging from 50-1000L, etc.
Influenza antigen
Customized formulation
Drug Product
- Vial filling
- Prefilled syringe filling
- Inspection, labeling, and final packaging
Certificates
US FDA GMP, EU PIC/S GMP, Taiwan FDA PIC/S GMP, Canadian Pharmaceutical GMP & GMP – Anvisa (Brazil), Halal certificate
Prefilled Syringe Filling
100 million doses/year
Vial Filling
200 million doses/year
Equipment
Safety device, filler & isolator, inspection, etc.
Packaging
Serialization, inspection, labeling, and packaging design
Analytical Laboratory
- Analytical method development
- Validation support
- Qualification testing
- Stability testing
PROCESS DEVELOPMENT
Our extensive experience in process development ensures stable supply. We offer customized manufacturing solutions to bridge the gap between upstream and downstream processes
Manufacturing Process Optimization
Scale-up Assistance
Shake Flask Culture & 50-1,000L Bioreactors
ONE-STOP
Adimmune understands the challenges in biotech manufacturing. Our one-stop service offers a comprehensive solution to our clients. Granted PIC/S GMP certificates by competent authorities, we ensure robust process, serialization, and regulatory compliance
prefilled syringes
100
million
vials
200
million
Why Adimmune?
01
CELL CULTURE SYSTEM AND 50L– 1,000L bioreactorS
02
Prefilled syringe & vial fill- finish
03
Serialization
04
Automated packaging
REGULATORY SUPPORT
CMC Development
Quality Control
Quality Assurance
Manufacturing
Research & Development
Transparent communication within our departments and between our partners is valuable for the Chemistry, Manufacturing, and Controls (CMC) dossier. Our CMC support includes:
Dialogue with Regulatory Authority
Quality & Compliance Support
Regulatory Operations
Global Market Entry
Our Regulatory Affairs team worked with competent authorities from the United States, European Union, Thailand, Japan, China, and Taiwan. We are also exploring markets such as the Middle East and Southeast Asia
Our knowledge of the global regulatory landscape is the key to our global presence. Together with our clients, a co-designed regulatory strategy facilitates successful market entry.
- CDMO
- Marketing Authorization Holder
- Exploring
PRODUCT
