Insulin Lispro, Recombinant

Modality

Insulin Lispro, Recombinant

Description of Insulin Lispro, Recombinant

Insulin lispro is a fast-acting insulin comprising human insulin analog with the engineered amino acid sequence at B chain, with the chemical name of Lys(B28), Pro(B29) human insulin analog.

Formulations based on insulin lispro have been available on the market since 1996 with the brand name Humalog (Lilly); and other available products include Lyumjev (Lilly), and Admelog (Sanoﬁ).

Synonyms

Insulin Lispro (Genetical Recombination), insulin lispro-aabc, Eglucent, Humalog, Humalog Cart, Humalog Miriopen, Humalog Mix, Liprolog, Liumjev, LY-275585, LY-900014, LY-900027, LYS-B28, LYSPRO, Lyumjev, PRO-B29, ルムジェブ, Admelog

Fig 1. Structure formula of insulin lispro

Expression system of Insulin Lispro

Brand Name	Active Substance	Expression System
Humalog	Insulin lispro	Bacteria (Escherichia coli)
Liprolog	Insulin lispro	Bacteria (Escherichia coli)
Lyumjev	Insulin lispro	Bacteria (Escherichia coli)
Admelog	Insulin lispro	Bacteria (Escherichia coli)

Formulation of Insulin Lispro

Inactive ingredients (Excipients) in Humalog (Vial, Prefilled Cartridge)

Dibasic sodium phosphate, glycerin, metacresol (m-cresol), phenol (trace amounts), zinc oxide, and hydrochloric acid or sodium hydroxide (pH 7.0-7.8).

Inactive ingredients (Excipients) in Liprolog (Vial, Prefilled Cartridge)

Dibasic sodium phosphate, glycerin, metacresol (m-cresol), zinc oxide.

Inactive ingredients (Excipients) in Lyumjev (Vial, Prefilled Cartridge)

Glycerol, magnesium chloride hexahydrate, metacresol, sodium citrate dihydrate, treprostinil sodium, zinc oxide, and hydrochloric acid or sodium hydroxide (pH 7.0-7.8).

Inactive ingredients (Excipients) in Admelog (Vial, Prefilled Cartridge)

Dibasic sodium phosphate, glycerin, metacresol (m-cresol), zinc oxide, and hydrochloric acid or sodium hydroxide (pH 7.0-7.8).

Manufacturing Process of Insulin Lispro

Upstream Process

E. coli strain expanded in a shake flask from a vial of Working Cell Bank (WCB);
Fermentation: seed fermentation; and induction of expression of insulin lispro by high-density fermentation.

Downstream Process

Harvesting E. coli cells and inclusion bodies by centrifugation and cell lysis.
Refolding of inclusion bodies to produce insulin lispro precursor;
Enzymatic cleavage and purification to obtain pure active substance.

Fill and Finish

Formulation preparation and aseptic fill-finish in vials or prefilled cartridges.

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Insulin Lispro, Recombinant

Modality