Patrick Lucy, president and chief executive officer, Lykan Bioscience

Presented by: Patrick Lucy, president and chief executive officer, Lykan Bioscience

Lykan Bioscience is a cell-therapy–focused contract development manufacturing organization (CDMO) based in Hopkinton, MA. Lucy’s presentation showcased his company’s new purpose-built manufacturing facility and described how its design can help to expedite manufacturing of cell therapy products. Emphasizing the highly individualized nature of autologous therapy production, Lucy also explained how the Lykan team integrates its logistical and manufacturing operations to maximize patient access to lifesaving treatments.

Lykan’s 64,000-ft2 facility includes eight independent manufacturing suites, all of which are compliant with current good manufacturing practice (CGMP) standards. Those units are supported by fully equipped technology transfer, process development, and quality control (QC) laboratories. The facility incorporates innovative workspace designs to facilitate interactions between Lykan employees and partners. The site is located 30 miles south of Boston and within reach of three major airports, enabling rapid delivery of time-sensitive cell therapy products.

Lucy provided a virtual tour of his company’s facility, beginning with a suite dedicated to receipt of patient materials and establishment of chain of custody. The company’s fully integrated software systems can track inbound patient products and outgoing drug products in real time. For instance, when a clinic, hospital, or treatment facility notifies Lykan that materials are en route, the system initiates a cascade of logistical operations that move personnel and resources to the manufacturing suite in which that material will be processed. Lykan’s 4,800-ft2 CGMP warehouse for quarantine and release of requisite raw materials also is integrated with the company’s electronic management systems. Connectivity across operations and units, Lucy explained, helps Lykan scientists to work with patient cells quickly and efficiently. That presents clear advantages considering the time-sensitivity of cell-therapy products.

Because of its extensive analytical capabilities, Lykan performs most product testing internally. The company’s facility features three QC laboratories that are outfitted for evaluation of in-process materials and final products, raw materials, and environmental monitoring. The laboratories are segregated fully to prevent cross-contamination of samples and products. The Lykan QC team also has capabilities for rapid sterility and mycoplasma evaluation, enabling real-time testing and release of drug products.

Lucy emphasized that Lykan’s facility is fully validated and that all of its manufacturing suites and support laboratories can accommodate both clinical and commercial manufacturing of cell-therapy products. The manufacturing suites can run independently because each suite uses its own air-handling unit. Lucy added that the company leverages “incubator farms” to maximize throughput.

All Lykan units are staffed by process engineers and scientists who have significant experience with cell therapy production. Among the staff are teams that helped to develop the first cell-based immunotherapy to receive US Food and Drug Administration (FDA) approval over a decade ago.

Currently, Lykan is reestablishing its CGMP certifications and has begun transferring its first customer from development into manufacturing operations. The company plans to initiate clinical-grade manufacturing late in 2021, and it is eager to play a significant role in delivering innovative cell therapies to patients with high unmet medical needs.