Sanyou Biopharmaceuticals provides
integrated
services for
PCC-to-IND antibody drug R&D.One-stop solutions with integrated project management and execution,
and accelerating the clinical trail initiation for competitive advantages. Once a PCC antibody is determined,
it
takes about 12 months to complete the preclinical R&D and IND filing. Sanyou has completed the PCC-to-IND
development of several client’s projects which have been submitted for IND in
both China and the U.S.
Service Overview
Sanyou Biopharmaceuticals provides integrated services for PCC-to-IND antibody drug R&D.
One-stop solutions with integrated project management and execution, and accelerating the clinical trail initiation for competitive advantages.
Once a PCC antibody is determined, it takes about 12 months to complete the preclinical R&D and IND filing.
Sanyou has completed the PCC-to-IND development of several client’s projects which have been submitted for IND in both China and the U.S.
Service Contents
Overview
Service
Service Contents
Client’s Material
Deliverables and Standards
Duration
PCC-to-IND antibody drug R&D services
1. Construction of production cell lines
2. Development of fermentation and purification process
3. Drug formulation development
4. Pilot-scale production
5. Toxicology study
6. IND application
Antibody sequence
1. Original cell bank, master cell bank and working cell bank
2. Lab-scale process development and qualification report
3. Analytical method development and qualification report
4. Production report, batch production and batch inspection records
5. MCB, WCB, EOPC and UPB inspection reports
6. Virus clearance validation report
7. Toxicology study reports
8. Two batches of pilot-scale drug substances and drug products
9. Stability study report
10. IND application documents
Approximately 12 months
Detailed
Service
Service Contents
Client-provided Materials
Deliverables and Standards
Duration
Construction of production cell lines
1. Cell pool construction
2. Monoclonal cell line selection
3. Cell line bank construction
4. Cell bank inspection
5. Cell bank stability study
Antibody sequence
1. 1–5 high-expression cell pools
2. 1–5 high-expression monoclonal cell lines
3. No less than 150 vials for master cell bank and working cell bank under GMP environment; cell bank construction records
4. Cell bank inspection records
5. Cell bank stability study report
1. 6–8 weeks
2. 7-9 weeks
3. 4-5 weeks
4. 10-16 weeks
5. 10-16 weeks
Development of fermentation and purification process
1. Selection and optimization of basic culture medium
2. Fermentation process development and qualification
3. Purification process development and qualification
Cell lines
1. Antibody titer ≥ 3 g/L
2. Good consistency of cell growth data, biochemical and metabolic data, antibody titer and antibody quality data obtained from incubations in 3-L and 15-L bioreactors.
3. The antibody purity and removal of product-related and process-related impurities comply with applicable regulations; process development and qualification reports
1. 4-5 weeks
2. 6–8 weeks
3. 6–8 weeks
Drug formulation development
1. Pre-formulation study
2. Selection of drug formulation
3. Drug formulation qualification
Drug products
1. The appearance, pH and protein purity of the drug product are qualified for the desired specifications.
2. The appearance, pH, osmolality, protein concentration, protein purity, insoluble particles and bio-activity of the drug product are qualified for the desired specifications..
3. Drug formulation process development and qualification reports
1. 3-5 weeks
2. 6-7 weeks
3. 12-14 weeks
Pilot-scale production
1. Drug substance production and drug product filling and packing
2. Samples collections of intermediate products for testing
3. EOPC and UPB inspection
4. Virus clearance validation
5. Stability study
6. Toxicology study
7. IND application documents
Cell lines
1. Drug substance and drug product production reports; batch production records of drug substance and drug product; two batches of drug substances and drug products
2. Batch inspection records
3. EOPC and UPB inspection reports
4. Virus clearance validation report
5. Stability study report
6. Toxicology study reports
7. IND application documents
1. 6-7 weeks
2. 1 week
3. 4-5 weeks
4. 12 weeks
5. 15-16 weeks
6. 4-6 weeks
Service Highlights
1. Integrated PCC-to-IND Services
With our integrated services, only antibody sequence information is required for the IND approval.
2. Over 30 Ongoing PCC-to-IND Projects
The disease spectrum includes hematologic malignancy, solid tumors, autoimmune disorders, eye diseases, metabolic disorders, infectious diseases, etc.
3. Experience of 5 IND projects
5 projects in the IND stage, with 1 application approved and 1 accepted.
4. IND Delivery in 12 Months
Integrated platforms enable 12-month delivery.
5. Various Drug Modalities
Various drug modalities such as monoclonal, bi-specific, trispecific antibodies and ADC.
6. Four Sets of Authorized Host Cells
Four sets of host cells supplied by Thermo Fisher, HORIZON, MERCK, and Quacells.
7. Antibody Titer Up To 12 g/L
Industry-leading antibody titer up to 12 g/L.
8. Antibody Drug R&D Team of 300 Professionals
Team with extensive experience of project management and fast troubleshooting.
9. 100% Successful Deliveries
100% successful deliveries guaranteed by advanced platform technologies and extensive R&D experiences.
10. Flexible and Customized Business Model
Flexible cooperation options oriented for successful project development.
Case Presentations
Since 2019, Sanyou has been leading the R&D of more than 30 PCC-to-IND projects, modalities of which involve monoclonal antibody, bi-specific antibody, tri-specific antibody and ADC. The progresses of several example projects are shown in the figure below.