We act as a steady guide through every step of the process, ensuring our clients are fully supported as their projects move into the clinical phase.
What sets Kanwhish apart is its hands-on approach to reagent development, such as reagent design and production. Rather than solely relying on industry-standard reagents, the company has developed in-house capabilities for reagent synthesis and characterization. This ensures that each reagent used is thoroughly understood and optimized for peak assay performance. By mastering this critical component, Kanwhish consistently achieves the highest level of quality and precision in its assays.
Stable reagent performance is especially crucial during long-term clinical trials that could span several years. Kanwhish’s ability to produce matched replacement reagents ensures uniformity and reliability in results over the course of a multi-year trial. In addition, Kanwhish also engineers or develops reagents for novel assays. For example, Kanwhish has created monoclonal antibody reagents for generic PK assay and invented positive control and detection reagents for a generic ADA assay that is solely offered by Kanwhish for antibody-based therapeutic candidates, including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates.
At Kanwhish, bioanalysis is about partnership and crafting solutions tailored to the individual needs of each client. Working closely with each client, Kanwhish designs, develops, validates and implements analytical methods for bioanalysis, regardless of whether it is in the preclinical or clinical phase.
“We act as a steady guide through every step of the process, ensuring our clients are fully supported as their projects move into the clinical phase,” says Dr. Linglong Zou, founder and CEO. “We also offer in-depth data interpretation and regulatory filing support, smoothing the path to market. This comprehensive guidance is particularly crucial for clients navigating the intricacies of submission requirements by agencies like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the first time.”
A story that speaks volumes about Kanwhish’s impact is of a client undergoing a Phase II clinical trial for a monoclonal antibody therapeutic. It faced a critical challenge, an apparently 80 percent anti-drug antibody (ADA) rate in the clinical study observed by another service provider. With doubt, the client turned to Kanwhish. The team quickly identified the problem—false-positive anti-drug antibody (ADA) results caused by assay interference—and refined the methodology to address target-related interference. By introducing an enhanced sample pretreatment process and a two-step interference removal approach, Kanwhish revealed the true ADA positive rate of just five percent, allowing the client to confidently proceed with development.
“Our intervention not only resolved a critical assay issue but restored the client’s confidence in their therapeutic candidate,” adds Dr. Zou.
At the heart of Kanwhish’s success is its powerhouse team that is deeply rooted in research and development expertise. With leadership trained in the U.S., the team draws from exposure to cutting-edge bioanalytical practices and global industry standards. Dr. Zou himself brings over 23 years of experience leading bioanalytical teams, having supported the development of more than 100 large molecules—12 of which reached market approval. This depth of experience empowers Kanwhish to offer solutions that are informed, strategic and rooted in real-world experience.
