Sorrento Completes GMP Mfg. Plant In Suzhou

Sorrento Therapeutics subsidiary, Levena Biopharma Co., Ltd., has completed construction and began operations at its 25,000-sq.- ft. GMP manufacturing facility in Suzhou, China. The facility will be dedicated to supporting Sorrento’s antibody drug conjugate (ADC) pipeline and service business.

Sorrento currently has 12 preclinical cancer focused ADCs that are partnered with biopharma companies worldwide, under the Levena brand, including a HER2-targeting ADC, which has an expected IND filing with the China Food and Drug Administration (CFDA) in 2017. Additionally, Sorrento is advancing two anti-cancer ADC product candidates into IND enabling studies, including its anti-CD38 ADC and an anti-c-MET ADC, both generated from Sorrento’s fully human GMAB library that leverage Levena’s site-specific conjugation chemistry (K-Lock and C-Lock) and proprietary novel toxin payloads.

“ADC process development and manufacturing has historically been challenging to the industry as it requires a high level of technical expertise and specific know how. Our new plant has been designed to provide full analytical support capabilities, GMP production of toxin-linkers based on our proprietary technology and methods, as well as GMP-grade bioconjugation of the antibody to produce ADCs. The launch of this state of the art plant, in addition to our existing ADC research sites in Nanjing, China and San Diego, demonstrates Sorrento’s commitment to our ADC pharmaceutical partners as well as ensures a consistent supply for our own ADC franchise which is nearing the clinic,” said Dr. Henry Ji, president and chief executive officer of Sorrento.

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