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news.US-based biotechnology company Trophogen has selected Maryland-based Advanced BioScience Laboratories (ABL) as a contract manufacturer for recombinant, human follicle-stimulating hormone (rhFSH) analog.
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The rhFSH analog is developed through Trophogen’s proprietary superagonist hormone technology platform originally licensed from the National Institutes of Health.
The contract manufacturing deal includes the technology transfer and cGMP production of Trophogen’s recombinant, rhFSH analog.
Under the terms of the alliance, ABL will provide scale-up services, conduct an Engineering Run and produce rhFSH under cGMP compliance for clinical studies scheduled in 2014.
Trophogen president and COO Bruce Weintraub said the company seeks to work with ABL to bring the analog to an IND and Phase 1/2 trial in 2014 and commence clinical development of its other superagonist analogs, under the agreement.