Earlier today Sorrento Therapeutics announced that its subsidiary, Levena Biopharma, completed construction of its new, 25,000 sq/ft GMP manufacturing facility in Suzhou, China. The facility will be fully dedicated to supporting Sorrento’s antibody-drug conjugate (ADC) product pipeline product candidates which focus on both solid tumors and hematological malignancies and growing service business.
The company, which has partnered with biopharmaceutical companies worldwide, currently has, under its Levana brand, a dozen pre-clinical ADCs in development. These partnerships includes the development of ADCs 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 is advancing two proprietary ADC product candidates into IND enabling studies, including its proprietary anti-CD38 ADC and an anti-c-MET ADC. Both investigational agents were generated using Sorrento’s fully human GMAB™ library and include Levena’s site-specific conjugation chemistry (K-Lock™ and C-Lock™) and novel cytotoxic payloads. The technology platform uses an innovative conjugation methods to produce stable ADCs by linking a cytotoxin to specific, preselected, sites of an antibody. The resulting ADCs have shown high anti-tumor efficacy and low overall toxicity in preclinical studies.
“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,” noted Henry Ji, President and CEO of Sorrento.
“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,” Ji added.
Levena Biopharma, established in 2013, has research and manufacturing sites in Suzhou, Nanjing and San Diego. The company provides small and large scale proof-of-concept (POC) antibody-drug conjugation services as well as complete characterization using advanced analytical tools such as HPLC (HIC, SEC, RP), iCIEF and LC-MS, quality assessment (Drug-to-Antibody Ratio, purity via SDS-PAGE, aggregation, endotoxin, residual drug and in vitro pharmacology for cytotoxicity studies.