Offers seamless, robust transfer of optimized processes from smallscale R&D lab to large-scale commercial manufacturing.
DARMSTADT, GERMANY: Merck Group in collaboration with Stelis Biopharma Pvt Ltd has opened its first joint process scale-up lab in Bengaluru, India. This lab provides end-to-end solutions from process development to scale-up manufacturing for pre-clinical, clinical and commercial supply.
This lab is located at the Stelis Biopharma R&D facility in the Jigani industrial estate.
The collaboration reinforces Merck’s position as the premier supplier of process development and clinical state manufacturing solutions, materials and services needed for biologics production.
The lab is a centre of excellence for process scale-up and manufacturing services. The collaboration brings together Stelis’ end-to-end capabilities in high-yield bioprocess development from cell line to commercial manufacturing scale and Merck’s industry-leading technological expertise in bioprocessing.
The process scale-up lab and a soon-to-be-completed cGMP manufacturing facility will house Merck’s portfolio of Mobius bioprocessing equipment and single-use manufacturing components. Merck will provide process know-how and application knowledge to help establish the single-use platform technologies at Stelis as part of the collaboration.
“Both Merck and Stelis bring technological expertise and an extensive bioprocess development and manufacturing portfolio that will help customers accelerate development of biopharmaceuticals for clinical trials and manufacturing with greater reliability and cost effectiveness,” said Udit Batra, member of the Merck executive board and CEO, life science.
“In the biopharma space, where the process is the product, our process scale-up lab fulfils a critical need by offering clients a reliable process bridge between R&D and commercial scales. The collaboration with Merck completes the value proposition for CDMO customers by providing an end-to-end solution from process development and scale-up through to manufacturing for pre-clinical, clinical and commercial supply,” said Joe Thomas, CEO of Stelis Biopharma.
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