Liquid formulation of long-acting human growth hormone conjugate

摘要

Disclosed is a liquid formulation of long-acting human growth hormone (hGH) conjugate, free of albumin, which can guarantee the stability of the long-acting hGH conjugate when stored over a long period of time, wherein the long-acting human growth hormone conjugate includes a human growth hormone linked to an immunoglobulin Fc region, and has a prolonged in vivo stability compared to the native form. The liquid formulation of hGH conjugate including a pH 5.0˜6.0 buffer, a sugar alcohol, a salt and a non-ionic surfactant is free of human serum albumin and other hazardous factors which are potentially contaminated with viruses, and can provide excellent storage stability customized for a long-acting hGH conjugate composed of an hGH polypeptide and an immunoglobulin Fc region which has higher molecular weight and in vivo durability, compared to the native.

主权项

1. A liquid formulation of a long-acting human growth hormone conjugate, comprising
a pharmaceutically effective amount of the long-acting human growth hormone conjugate in which the human growth hormone and an immunoglobulin Fc region are linked to each other via a polyethylene glycol; and an albumin-free stabilizer, said stabilizer consisting essentially of a buffer of pH 5.0-6.0, a sugar alcohol, a polysorbate as a non-ionic surfactant and sodium chloride as a tonicity agent.