During the process of CGT, antibodies and proteins are used as a key raw material or active pharmaceutical ingredient for T/NK cell and stem cell , their development and manufacturing should follow the requirements of the regulations.
ProBio provides flexible, simplified and regulation-complaint antibody and protein CMC solutions for key raw material or active pharmaceutical ingredient of CGT, and has established small scale GMP manufacturing facility to meet the milligram level to gram level manufacturing needs.
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- GMP material
- API apply for IIT and IND
- ABP apply for IIT and IND
5 Flexible packages for CGT:
* API (Active Pharmaceutical Ingredient)
* ABP (Antibody Product) -
- 5 months from DNA to GMP batch
- As fast as 3.5 months from DNA to IIT material
- As fast as 5.5 months from DNA to Tox batch
Fast timeline:
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- High-expressing cell line platform, ProBox for process development and analytical development
- Successfully delivered bsAb & protein CMC:
- Trispecific antibody
- Ab-cytokine conjugate
- Cytokine
Robust cell line & PD platform:
* ProBox: Highly-efficient solutions for antibody development
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- EU QP audited facility and quality system
- Support 25L to 500L production volume in GMP facility
- 5*25L wave
- 2*50L bioreactor
- 8*200L bioreactor
- 2*500L bioreactor
Unique small scale CHO-derived GMP manufacturing facility:
| GMP material for cell culture and purification | API for CGT | Ab Product (ABP) for CGT | |||
| GMP material | Apply for IIT | Apply for IND | Apply for IIT | Apply for IND | |
| Quality system | ISO9001+GMP (Critical Material Grade) | ISO9001 | ISO9001+GMP (API Grade) | ISO9001 | ISO9001+GMP (Drug Grade) |
| Process development strategy | Single clone (cell bank characterization) | Cell pool (mycoplasma free) | Single clone (cell bank characterization) | Cell pool (mycoplasma free) | Single clone (cell bank characterization) |
| Platform upstream & downstream process confirmation | Follow platform upstream & downstream process | Platform upstream & downstream process confirmation | Follow platform upstream & downstream process | Platform upstream & downstream process development | |
| Use customer’s formulation | pH/buffer confirmation | pH/buffer confirmation | pH/buffer confirmation | Formulation development | |
| Platform method partial qualification | No method development and qualification | Platform method development and qualification | No method development and qualification | Platform method development and qualification | |
| VC process (Keep sample for VC study) | / | VC process | / | VC process | |
| Manufactur-ing strategy | Critical material grade GMP | High Quality grade | API grade GMP | High Quality grade | Inject grade GMP |
| 25L, 50L, 80L, 100L | 10L | 25L, 50L, 80L, 100L | 10L | 25, 50L, 80L, 100L | |
| Simplified process instruction | / | Simplified process instruction | / | Customized process instruction | |
| Template batch record | / | Template batch record | / | Customized batch record | |
| COA release for raw material, critical item testing for excipients | / | COA release for raw material, critical item testing for excipients | / | Critical item testing for raw material, full testing for excipients | |
| Recycled resin & membrane | Project-exclusive resin & membrane | Project-exclusive resin & membrane | |||
| Multiple project in parallel | / | Multiple project in parallel | / | Cleaning validation before project changeover | |
| C+A manual subpackaging（ISO500 grade） | Manual sub packaging | C+A manual subpackaging（ISO500 grade） | Manual filling or B+A filling | B+A filling | |
Capabilities of Development and Manufacturing
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Platform Cell Line
(ProCLD)- Rich experience in cell line development (200 projects)
- Short timeline (10 weeks)
- High productivity (up to 15g/L)
- Proprietary expression vector
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Platform Process & Analytical
Development- Robust and efficient platform process and method development
- ProBox: solutions for bispecific antibody and protein development
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Small Scale GMP Protein
Manufacturing- Completely animal-free
- EU QP audited facility and quality system
- Support various scale：25L,50L,80L,100L GMP manufacturing
