GC Biopharma signs biopharma manufacturing MOU with Merck

Strengthening cooperation on the supply of raw material for biopharmaceuticals, including Alyglo, Hunterase

Companies aim to streamline manufacturing processes and enhance supply stability

Will operate regular technical consultative bodies and explore opportunities for joint R&D

GC Biopharma is joining hands with global science and technology company Merck Life Science to strengthen its competitiveness in biopharmaceutical manufacturing. Through the partnership, the companies aim to secure stable supplies of key raw and subsidiary materials while improving manufacturing process efficiency to strengthen global market responsiveness.

GC Biopharma announced on the 14th that it signed a strategic memorandum of understanding (MOU) with Merck Life Science for cooperation in biopharmaceutical development and GMP manufacturing processes.

The signing ceremony was held at Merck Korea headquarters in Gangnam, Seoul. Major officials from both companies attended, including Young-im Kim, head of Merck Life Science Process Solutions Business, and Woong Shin, head of Quality Management at GC Biopharma.

Through this agreement, GC Biopharma plans to strengthen cooperation on the supply of major raw and subsidiary materials needed for biopharmaceutical production and establish a collaborative framework to improve manufacturing efficiency and supply stability.

In particular, GC Biopharma expects to secure a stable production base for major global products, such as its plasma-derived therapy Alyglo and the Hunter syndrome treatment Hunterase, both launched in the U.S. market, and respond more flexibly to changes in global demand.

Merck plans to provide a collaborative framework covering the entire production process, from raw material procurement to process technology support. In particular, the companies aim to proactively manage supply chain risks that may arise during the manufacturing process by stably supplying product batches that meet strict internal quality control standards.

The two companies also plan to operate a regular technical and process consultation body to strengthen technical cooperation for manufacturing process efficiency. Through this, they intend to share the latest production technologies and process know-how to enhance quality competitiveness, while continuously seeking joint R&D opportunities to expand their cooperative relationship.

Woong Shin, Head of Quality Management at GC Biopharma, stated, “Through close technical cooperation and process optimization, we will work to minimize risks across the entire manufacturing process and build a production system with global-level quality competitiveness.”

Young-im Kim, head of Merck Life Science Process Solutions Business, said, “Through this collaboration, we will work to support an optimal manufacturing environment so that GC Biopharma’s key therapeutic products can be supplied stably.”