Established in 2007, Hanmi Bio Plant has been fully devoted to manufacturing biological medicine with highest quality.
We are experts in manufacturing and development of recombinant protein products based on microbial fermentation and biochemical conjugation reaction processes. Our current pipeline includes more than 10 biologics and medical device products in various clinical phases and commercialization.
In 2008, Hanmi Bio Plant received KGMP certification as well as Hyaluronate product approval. In 2011, its facility and Hyaluronate-based product have gained ISO 13485 certification from SGS. In 2018, our product obtained US FDA PMA approval as a Class 3 medical device product.
Detailed Introduction Page For a detailed Hanmi Bio Plant CMO/CDMO introduction, go to the page below.Hanmi Bio Plant CMO/CDMO page
In the bio plant complex, there are bio plant production buildings #1 and #2 operated for the production of new biopharmaceuticals using LAPSCOVERY technology. Bio Plant is committed to the development and commercialization of new drugs.
Clinical trials are underway for therapeutic areas and agents of:
A description of LAPSCOVERY products with an overview of how LAPSCOVERY products are manufactured at the Hanmi Bio Plant
An overview of Hanmi Bio Plant in terms of CDMO capabilities and manufacturing capacities
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