|
| |
|
|
|
| |
| Manufacture of BIOLOGICS |
Proteins
- Recombinant proteins, native proteins, monoclonal antibodies, fusion proteins.
- Vaccines
- Biosimilars
Other biological molecules
- Peptides
- Lipds
-
Carbohidrates
- Complex molecules
Related services:
- Generation of protein expression systems.
- Development and validation of analytical methods.
- Generation and characterization of MCB and WCB
- Cell bank storage.
- Development of stability studies.
- Release of raw materials, drug substances and drug products.
- GMP and Regulatory consulting assessment.
- Fill & finishing.
|
  |
|
|
| Manufacture of CELL THERAPY products |
| Advanced Therapy Medicinal Products
- Cell therapy products
- Tissue engineered products
Intermediate products:
- Cell culture media
- Biomaterials (scaffolds or membranes)
Related services:
- Isolation, culture (normoxia or hypoxia) and harvest in GMP and non-GMP conditions.
- Generation, characterization, storage and stability studies of cell banks.
- Autologous or allogeneic process.
- Scale up in different culture systems
- Analytical development and Quality controls for cell therapy process
- Final product formulation for cell based therapies
- Logistical services and shipping validation protocols
- GMP validation process
|
|
|
|
|
|
| |
|
| |
| |
|
|
|
|
|
|
