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Antibody & Protein CMC Solutions for CGT

Flexible solutions for IIT material, IND material and GMP material

As fast as 3.5 months from DNA to GMP material

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.

- GMP material
- API apply for IIT and IND
- ABP apply for IIT and IND
- 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

- High-expressing cell line platform, ProBox for process development and analytical development
- Successfully delivered bsAb & protein CMC:
  - Trispecific antibody
  - Ab-cytokine conjugate
  - Cytokine
- 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

Strategies for 5 Application Scenarios for CGT

	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

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
Platform Process & Analytical
Development
- Robust and efficient platform process and method development
- ProBox: solutions for bispecific antibody and protein development
Small Scale GMP Protein
Manufacturing
- Completely animal-free
- EU QP audited facility and quality system
- Support various scale：25L,50L,80L,100L GMP manufacturing

Antibody & Protein CMC Solutions for CGT

5 Flexible packages for CGT:

Fast timeline:

Robust cell line & PD platform:

Unique small scale CHO-derived GMP manufacturing facility:

Capabilities of Development and Manufacturing

Platform Cell Line
(ProCLD)

Platform Process & Analytical
Development

Small Scale GMP Protein
Manufacturing

Related Service

Antibody & Protein CMC Solutions for CGT

5 Flexible packages for CGT:

Fast timeline:

Robust cell line & PD platform:

Unique small scale CHO-derived GMP manufacturing facility:

Capabilities of Development and Manufacturing

Platform Cell Line (ProCLD)

Platform Process & Analytical Development

Small Scale GMP Protein Manufacturing

Related Service

Platform Cell Line
(ProCLD)

Platform Process & Analytical
Development

Small Scale GMP Protein
Manufacturing