Shanghai Pudong R&D and Manufacturing Site
It operates R&D and manufacturing facilities, offering one-stop Biologics and Conjugates CDMO services from Drug Substance (DS) to Drug Product (DP).
1st Floor, Building 3, 201 Huashen Road, China (Shanghai) Pilot Free Trade Zone, Shanghai 200131, China
2000+m2PD & AD Labs
The center includes facilities such as the Antibody Drug Substance Process Development Center, ADC Conjugation Process Development Center, Antibody and ADC Formulation Process Center, and Quality Research and Testing Center.
3000+m2GMP Mfg
We have GMP manufacturing capabilities and can provide comprehensive ADC drug DS+DP integrated services to our clients.
Services
Biologics and Conjugates Drugs
Biologics and Conjugates Drugs
As a subsidiary of Porton Pharma Solutions, a globally recognized CDMO, Porton Biologics and Conjugates CDMO Platform offers comprehensive, one-stop drug development and manufacturing services for biologics and conjugates, including ADCs, AOCs, PDCs, and more.
Facilities
PD & AD Labs
GMP Mfg.
PD & AD Labs
- Antibody DS PD Labs
- Antibody DP PD Labs
- Exclusive ADC Conjugation Labs
- AD Labs
GMP Mfg.
- Antibody DS Mfg
- Antibody DP Mfg
- Bioconjugation and Purification
- ADC Lyophilization
- QC and Warehouses
One Porton One Quality
Compliance standards, Continuous improvement, Customer oriented
Quality management runs throughout the entire process of the drug life cycle. The quality management system of the drug product site is built in accordance with international standards and continues to adhere to the quality concept of 'more well-established system, more controllable quality.' This ensures that the GMP activities of the drug product site meet the requirements of international quality management systems and market drug regulatory agencies, including those of China, the European Union, FDA, and other mainstream regulations.
Case Studies
Challenges and Advances in CMC Process Development of BsADCs
Preformulation Strategy- Inception to Completion
Efficacy and Safety - Guidelines for Clinical In-use Stability Studies of ADCs
Continuous Improvement of Project Life Cycle Management, Benefiting Customers by Reducing Total Cost
Overview and Case Study of Antibody Oligonucleotide Conjugates (AOC)
