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Nabi, Diosynth Enter Mfg. Pact

Nabi Biopharmaceuticals has entered into a five-year commercial manufacturing agreement with Diosynth RTP, Inc. for the manufacture of drug substance for NicVAX.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Nabi Biopharmaceuticals has entered into a five-year commercial manufacturing agreement with Diosynth RTP, Inc. for the manufacture of drug substance for the production of NicVAX, Nabi’s investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.

Diosynth will manufacture the drug substance AMNic-rEPA, which is produced by conjugating nicotine hapten — sourced from another CMO — with the carrier protein rEPA. The resulting drug substance will then be combined with an adjuvant and filled in syringes to produce NicVAX. Diosynth has already validated the NicVAX manufacturing process and produced commercial-scale lots of NicVAX under contract for Nabi.

“This agreement is an important and exciting step in the event that the Phase III trials for NicVAX are positive and we subsequently receive regulatory approval,” said Dr. Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. “We are pleased to enter into this agreement with Diosynth, an experienced manufacturer of licensed biological products with a regulatory approved facility and available capacity to perform bulk manufacture of the NicVAX Drug Substance.”


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