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A scalable low-cost cGMP process for clinical grade production of the HIV inhibitor 5P12-RANTES in Pichia pastoris

Madden, Knut
Tolstorukov, Ilya
Brown, Scott
Laukens, Bram
Callewaert, Nico
Harner, Jay C
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Published in Protein expression and purification. 2016, vol. 119, p. 1-10
Abstract In the continued absence of an effective anti-HIV vaccine, approximately 2 million new HIV infections occur every year, with over 95% of these in developing countries. Calls have been made for the development of anti-HIV drugs that can be formulated for topical use to prevent HIV transmission during sexual intercourse. Because these drugs are principally destined for use in low-resource regions, achieving production costs that are as low as possible is an absolute requirement. 5P12-RANTES, an analog of the human chemokine protein RANTES/CCL5, is a highly potent HIV entry inhibitor which acts by achieving potent blockade of the principal HIV coreceptor, CCR5. Here we describe the development and optimization of a scalable low-cost production process for 5P12-RANTES based on expression in Pichia pastoris. At pilot (150 L) scale, this cGMP compliant process yielded 30 g of clinical grade 5P12-RANTES. As well as providing sufficient material for the first stage of clinical development, this process represents an important step towards achieving production of 5P12-RANTES at a cost and scale appropriate to meet needs for topical HIV prevention worldwide.
PMID: 26506568
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Research group Hiv (835)
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CERINI, Fabrice et al. A scalable low-cost cGMP process for clinical grade production of the HIV inhibitor 5P12-RANTES in Pichia pastoris. In: Protein expression and purification, 2016, vol. 119, p. 1-10. doi: 10.1016/j.pep.2015.10.011 https://archive-ouverte.unige.ch/unige:88663

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Deposited on : 2016-11-03

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