OPM Biosciences expands OPM-CHO platform for biosimilar development and manufacturing

OPM Biosciences has launched the Biosimilar Media Optimization Service and Sureness™ Biosimilar Platform. The offerings extend the company’s OPM-CHO platform to help biosimilar developers improve productivity, align critical quality attributes (CQAs) with reference biologics, maintain process knowledge, and advance programs from cell line development through commercial manufacturing and regulatory support.

Cell culture media for CHO-based biomanufacturing

Cell culture media can significantly influence cell growth, productivity, and CQAs, making media strategy an important part of biosimilar process development.

OPM-CHO cell culture media comprises OPM Biosciences’ portfolio of chemically defined media for Chinese hamster ovary (CHO)-based biomanufacturing. The portfolio has supported more than 390 molecules in clinical and commercial stages worldwide, including biosimilars.

Across 35 side-by-side evaluations, OPM-CHO media delivered an average titer improvement of 96% compared with each program’s original media combinations.* In separate internal studies, the media demonstrated lot-to-lot variability below 5%.*

Molecule-specific biosimilar media optimization

As patent expirations create opportunities for biosimilar development, achieving a product quality profile comparable to the reference biologic remains a central technical challenge.

Building on OPM-CHO, the Biosimilar Media Optimization Service uses molecule-specific media development to tune key CQAs toward the reference-product profile while optimizing productivity and process performance. This approach allows developers to address product quality and productivity together instead of treating them as separate optimization steps.

Across more than 70 completed optimization projects, the service delivered an average titer improvement of 81% relative to each program’s starting process. Improvements exceeded 150% in select programs.*

Integrated biosimilar development and manufacturing

The Sureness™ Biosimilar Platform extends the strategy from cell line and process development through analytical characterization, scale-up, manufacturing, and regulatory support.

By integrating media development and contract development and manufacturing organization (CDMO) capabilities within a coordinated framework, the platform is designed to reduce technical handoffs and preserve process knowledge as programs advance.

Sureness has supported programs that progressed through regulatory submissions and approvals in the U.S., China, and other global markets. The platform has also completed multiple biosimilar chemistry, manufacturing, and controls (CMC) programs involving monoclonal and bispecific antibodies, antibody-drug conjugates, enzymes, and other complex biologics.

“Biosimilar development is no longer simply about maximizing titer. The challenge is achieving the right combination of productivity, product quality, process robustness, and cost,” said Yunfen (Fiona) He, President of OPM Biosciences. “By connecting OPM-CHO, molecule-specific media optimization, and integrated development and manufacturing, we provide biosimilar developers with a more efficient path from cell line to commercial production.”

*Figures reported by OPM Biosciences.

Want the latest science news straight to your inbox? Become a SelectScience member for free today>>