One-Stop Solution

Empowering Your Therapeutic Drug Development Journey

Cell Line Development

Cell line development is the first step in chemical manufacturing and control (CMC) stage and the basis of process development, which determines quality of final products.

We cooperate with many leading cell line development suppliers as well as offering multiple CHO-based expression platforms of our own. We have delivered cell line development projects including mAbs, bsAbs and fusion proteins with robust process, high-yield expression, scalability and excellent cell line stability. These projects have entered subsequent CMC development stages and clinical research applications, and have been successfully approved in the United States, Europe, Australia and China.

Process Development

Our experienced team leverages state-of-the-art technologies and proven process optimization methodologies to help clients achieve enhanced product quality, increased yields, and accelerated timelines from preclinical to commercial scale.

With our customized approach, we identify the most promising process options tailored to your specific molecule and objectives. Our focus on innovation enables us to rapidly optimize processes while mitigating risks, leading to reliable and efficient manufacturing processes. Partner with us for seamless process development and production of your biologic drug candidates.

cGMP Manufacturing

We partner with a long-term, reliable collaborator who provides manufacturing capacity for drug substance batches, including mAbs, bsAbs, and other fusion proteins, ranging from 200L to 2,000L for preclinical to commercial use.

Our continuous focus on process robustness, control strategy improvements, and innovative technologies demonstrates our commitment to operational excellence in cGMP manufacturing.

Fill & Finish

Our long-term partner operates three aseptic filling lines with validated capabilities to accurately fill vials, syringes, cartridges, and lyophilized products for clinical supply through to commercial batch sizes over 100,000 units.

With fully automated systems, these filling lines operate with minimal over-fill volume and improve the utilization rate to effectively increase capacity and reduce unit cost with minimum risk of contamination from operator intervention.

GMP Quality System

We maintain a robust quality system for in-house GxP activities and external partner manufacturing management. A quality agreement is established before project initiation, ensuring close monitoring and collaboration on all quality-related activities throughout the project. Periodic reviews and updates are conducted to ensure that the entire project adheres to Nona’s quality system.

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