Samsung BioLogics said Thursday that it has signed a memorandum of understanding with Merck, a German biotech firm, to further their strategic alliance on biopharmaceutical manufacturing and biologics process development.

Dr. Tae-Han Kim, President and CEO of Samsung BioLogics, Left, and Udit Batra, Member of the Merck Executive Board and CEO, Life Science, right, sign a Memorandum of Understanding for a strategic alliance on biopharmaceutical manufacturing and biologics process development

The alliance will accelerate process development and clinical material production at small biotech start-ups focusing on novel drug development, for which Samsung BioLogics acts as a contract manufacturer, it added. Under the agreement, Merck will provide process development, technical support training and supply its Mobius disposable systems to Samsung BioLogics.

The new MOU is an extension of the existing one signed in 2014, which encompasses a long-term supply agreement where Merck would provide raw materials for biopharmaceutical manufacturing.

Merck has provided Samsung BioLogics with core solutions for its 30- kiloliter and 152-kiloliter facilities in Korea, and has trained Samsung BioLogics team on building a robust biologics development process.

"We will continue to strengthen the collaboration with Samsung through this agreement," said Udit Batra, a member of Merck’s executive board and head of its life science unit. “Merck's expertise along with Mobius, a diverse disposable bioprocess portfolio, will revolutionize the rapid development of therapeutic drugs.”

Samsung BioLogics 삼성바이오로직스 CEO Kim Tae-han 김태한 said, “This collaboration is expected to create synergy and maximize our technological potential.”

Merck's portfolio of Mobius disposable systems offers flexibility and continuity for scale-up, which reduces operator latency, the Korean company said in a news release.

Another advantage of using Merck includes M Lab, Merck’s dedicated collaboration center. Here, customers can work with the company’s scientists and engineers in a shared research environment to solve the most difficult bio-manufacturing problems and accelerates the development of new therapeutics. Merck has nine M Lab Collaboration Centers around the world, including one in the U.S. and one in Korea, it added.

In the growing biopharmaceutical market, manufacturers are moving toward end-to-end solutions — from process development and scale-up through to manufacturing for pre-clinical, clinical and commercial supply — as they seek to cut costs while increasing quality and efficiency.

At the same time, single-use, disposable equipment, and systems have increased in popularity because they offer many advantages over conventional stainless steel systems, such as improved batch success rates, less cross-contamination risk, decreased water and wastewater requirements, shortened project duration and reduced project costs, according to the release.

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