GenScript ProBio to Manufacture Innovative Antibody Drug

06 September 2021 | Monday | News

GenScript ProBio is delighted to announce the signing of a manufacturing service agreement for Synimmune's innovative FLYSYN antibody project for clinical Phase II production
Image Source : Public Domain

Image Source : Public Domain

FLYSYN is a fms-like tyrosine kinase 3 (FLT3) specific antibody for the treatment of acute myeloid leukemia (AML) patients in complete remission. FLYSYN was recently evaluated in a Phase I/II study in Germany. FLYSYN contains a genetic optimization of its Fc-part resulting in optimized binding to cells expressing the Fc receptor, particularly Natural Killer (NK) cells, and thus substantially improved antibody-dependent cell-mediated cytotoxicity (ADCC).

GenScript ProBio's GMP manufacturing center follows the internationally leading design concept and is a true "zero-crossover, unidirectional flow" plant, which meets FDA, EMA and NMPA regulatory requirements. Strict physical isolation measures are adopted in the whole facility, which ensures the manufacturing of multiple samples at the same time.

"GenScript ProBio and SYNIMMUNE GmbH entered into collaboration on FLYSYN antibody project for technology transfer and manufacturing of  drug substance and drug product for Clinical Phase II trials, it is our pleasure to support this innovative antibody project," said Dr. Brian Min, CEO of GenScript ProBio, "GenScript ProBio's GMP manufacturing center meets global regulatory requirements. ProBio's technology transfer team has established a comprehensive and refined technology transfer process and has implemented comprehensive risk control in the technology transfer process, which ensures the smooth tech transfer. We look forward to the further progress of this innovative antibody project."

"We are pleased to enter into a partnership with GenScript ProBio, a highly professional and competent CDMO. We are confident that GenScript ProBio will produce SYNIMMUNE's lead antibody drug product FLYSYN to all global quality GMP standards within the agreed upon timeline. We are planning to test FLYSYN in an international, multicenter Phase II clinical study in AML patients to obtain additional indications for efficacy in this poorly treated patient population," said Dr. Martin Steiner, CEO of SYNIMMUNE GmbH.

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