Lotte Biologics, Asimov unveil next-gen CDO model that cuts DNA-to-GMP timeline to 8.5 months

Lotte Biologics has teamed up with US biotech firm Asimov to unveil a next-generation contract development organization (CDO) collaboration model that dramatically compresses the timeline from cell line development to drug substance production.

Lotte Biologics announced Sunday that it presented the new CDMO collaboration model and joint project results alongside Asimov at the 2026 BIO International Convention, known as BIO USA 2026, held in San Diego.

The presentation, titled "Eliminating Partner Complexity in Development & Manufacturing," was delivered at Lotte Biologics' dedicated exhibition booth by Angela Au, the company's MSAT director, and Imroz Ghangas, Asimov's vice president of global commercial sales.

The biopharmaceutical market is increasingly centered on high-complexity modalities such as bispecific antibodies and antibody-drug conjugates (ADCs), making the development process more demanding. As AI and synthetic biology technologies are adopted at an accelerating pace, managing risk from the earliest stages and accelerating development have become central to competitiveness.

The two companies said they built a new collaboration framework connecting every step — from cell line development through GMP production — as if operated by a single team. "Traditional biopharmaceutical development ran cell line development, process development and GMP manufacturing sequentially through separate organizations, which could cause schedule delays, redundant work and quality risks during technology transfer," Au said. "We moved beyond a simple handoff model to build an orchestrated approach where each party retains its own expertise while operating as one project team."

Asimov designs vectors optimized for each molecule's characteristics and rapidly secures early-stage material through its AI- and synthetic biology-based cell line development platform, CHO Edge. Building on that foundation, Lotte Biologics begins analytical method development and downstream process evaluation and optimization early, and runs Pool-to-Tox and Tox-to-GMP production in parallel, dramatically shortening the overall development timeline.

The two companies also established joint milestones spanning the entire process from cell line development to GMP production, and applied mock technology transfers and an integrated quality system to align schedules and quality standards in advance. This minimized the risk of delays and rework that can arise during technology transfer.

Concrete project results were also presented. "Traditional cell line development supplied material only once — at the point of final clone selection, roughly 18 weeks in — but Asimov's CHO Edge platform provides four early supply points throughout the development process," Ghangas said. "A Pool RCB is secured approximately seven weeks after transfection, and Early Look Material is supplied in week eight, enabling Lotte Biologics to begin downstream process development and analytical method optimization in parallel at an early stage."

He added that running Pool-to-Tox and Tox-to-GMP strategies in parallel, combined with the integrated quality system and joint milestone management, allowed key parameters across cell line development, process development and GMP manufacturing to be aligned in advance, minimizing technology transfer risk.

As a result, the collaboration — spanning cell line development, process development and GMP manufacturing — completed the entire workflow from the DNA stage through drug substance production and clinical material supply in approximately 8.5 months. The company said it also secured cell lines yielding 8–12 g/L even at the early stages of process development, demonstrating high productivity and stability.

The achievement is expected to apply not only to monoclonal antibodies but also to complex modalities including bispecific antibodies, ADCs and fusion proteins, strengthening competitiveness in next-generation biopharmaceutical development and manufacturing.

"In an increasingly complex biopharmaceutical development environment, optimizing each stage individually is not enough — the entire process must be connected as one," Au said. "This case shows how much synergy an integrated development and manufacturing system can generate." She added that the company would continue expanding its differentiated one-stop service to help global customers shorten development timelines and accelerate market entry.