US Sorrento Therapeutics completes GMP Manufacturing Plant in China

Sorrento Therapeutics Inc has announced that its subsidiary, Levena Biopharma Co Ltd, has completed construction and put into operation a 25,000 square foot Good Manufacturing Practice (GMP) manufacturing facility in Suzhou, China. The facility will be fully dedicated to supporting Sorrento’s antibody drug conjugate (ADC) pipeline and growing service business.
Sorrento currently has a dozen pre-clinical cancer focused ADCs that are partnered with biopharmaceutical companies worldwide, under the Levena brand. These partnerships have ADC candidates at various stages of development, including a HER2-targeting ADC which has an expected IND filing with the China Food and Drug Administration (CFDA) in 2017. Sorrento expects to receive service revenue and royalties on its partnered ADC programs. Additionally, Sorrento is advancing two proprietary anti-cancer ADC product candidates into IND enabling studies, including its proprietary anti-CD38 ADC and an anti-c-MET ADC. Both proprietary anti-cancer ADC programs were generated from Sorrento’s fully human GMAB™ library and leverage on Levena’s proprietary 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 CEO of Sorrento.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for immuno-oncology, inflammation and autoimmune diseases. Sorrento’s lead product candidates include immunotherapies focused on the treatment of both solid tumors and hematological malignancies, as well as late stage pain products.
Levena Biopharma, established in 2013, is engaged in technology partnership and process development to enable novel antibody-drug conjugate (ADC) therapeutic development. The company has research and manufacturing sites in Suzhou, Nanjing and San Diego.