Humedix corporate identity image. [Provided by Humedix]
Humedix corporate identity image. [Provided by Humedix]

Humedix has received Good Manufacturing Practice certification from the Ministry of Food and Drug Safety for its biopharmaceutical production line, positioning the company to make a full push into the biotech contract manufacturing organization market.

The aesthetic and pharmaceutical arm of Huons Group announced Monday that it had obtained final GMP approval from the Ministry of Food and Drug Safety for its finished-product manufacturing facilities for recombinant biopharmaceuticals.

The certification demonstrates that Humedix has established an advanced production and quality system spanning biopharmaceuticals in addition to its existing chemical drugs and aesthetic products. The company plans to use the newly certified biotech GMP line to handle finished-product manufacturing for a human-derived hyaluronidase biopharmaceutical being developed by its affiliate Huons Lab.

Huons Lab is working toward product approval in the second half of this year, and Humedix said it is now ready to begin commercial production immediately upon receiving that approval. The certified manufacturing facility has a production capacity of 100 liters.

The expansion into biotech CMO from a portfolio centered on aesthetic products such as fillers and botulinum toxin and chemical injectables is expected to complete an in-house value chain across group affiliates while opening a new growth avenue in the high-value-added contract biopharmaceutical manufacturing market.

"This biotech GMP certification is recognition that Humedix's injectable manufacturing technology and quality management capabilities are at the highest level in the biotech field as well," said Kang Min-jong, chief executive of Humedix. "We will continue to strengthen our biotech CMO capabilities to secure future growth drivers."


silverpaper@heraldcorp.com