NANJING, China, Dec. 27, 2023 /PRNewswire/ -- PharmaBlock Sciences (Nanjing), Inc. (Stock code: 300725.SZSE), a global, fully integrated CRDMO company, focusing on innovative chemistry and low-carbon manufacturing, has announced opening of a new high potency API (HPAPI) GMP facility (OEB-5 and above) at its Zhejiang manufacturing site.
The new HPAPI GMP facility enables PharmaBlock to offer process R&D and kilo-scale production of HPAPIs and ADC toxins. It spans an area of 1000 m2, and is equipped with multifunctional rigid isolators, reactors ranging from 20 L to 100 L. The facility allows handling of potent compounds with Occupational Exposure Limit (OEL) as low as 50 ng/m3 (OEB-5 and above). In addition to this new GMP HPAPI facility, multiple workshops at PharmaBlock Zhejiang are capable to manufacture OEB-4 compounds.
Rigid isolators and reactors in the clean room
Currently, PharmaBlock is enhancing its capabilities to provide research, development, and manufacturing services for new modalities, including targeted protein degraders, peptides, oligonucleotides, and ADCs, offering partners with comprehensive and highly flexible solutions. In the ADC field, the company is enriching its library of linker-payload intermediates and building blocks to support ADC drug R&D. It can also provide ADC chemistry CMC services, including linker-payload synthesis and ADC conjugation. The company has successfully delivered process development and kilogram-scale production of several innovative linkers, and process optimization of payloads. The new HPAPI GMP facility is a crucial addition to support the delivery of ADC projects to global partners.