Innovative CDMO Solutions For Cell-Based Therapies

The Lykan facility has been built for maximum flexibility. Suite sizes vary, with smaller suites that are suitable for individual patient material processing and larger suites that can accommodate allogeneic processes at higher volumes.

Suites may be dedicated or shared, and suite layouts can be changed to accommodate our partners’ manufacturing processes.

Our QMS and logistics processes cover all scenarios, from fresh-in/fresh-out autologous processes through large-scale allogeneic processes and Lykan offers cryopreservation services for products that can be stored for future use.

The Lykan facility has been specifically designed for appropriate segregation of concurrent manufacturing activities. The flow of materials is designed to prevent mix-ups and minimize potential contamination.

Handling of the patient starting material is governed by specific processes and procedures with additional considerations for ensuring COC and COI, clinical study-specific labeling, inbound and outbound expiry, and logistics, segregation, and environmental controls.

The patient material is issued a product-specific COI number at the time of scheduling. COC and store conditions are tracked and maintained throughout the transfer.

The patient material is received through segregation, access-controlled location, inspected and released per the defined release criteria. Established procedures and electronic systems ensure that COI and COC are maintained at all times.

Upon the initialization of processing, the patient material is transferred from the receiving/inspection location to the incoming Patient Materials Room where it is prepared for cleanroom entry, and the COI is once again verified. The patient material is then transferred to the assigned processing site.

Lykan intentionally refers to its manufacturing facility as “purpose built” because the layout of the facility, from the ground up, was specifically designed for the efficient and compliant production of cell therapy products. Many facilities currently being used for cell therapy manufacturing were originally built for an alternative purpose. While this is possible, it is suboptimal as the product flows and processing spaces in most retrofitted facilities are not designed for true patient material isolation and prevention of cross-contamination.  In the facility planning process, Lykan’s highly experienced architectural and engineering team considered all aspects of a cell therapy operation including people, process, and material flows in line with global regulatory requirements. In addition, our extensive use of sophisticated, state of the art software platforms facilitates the real-time transfer of data, reduces errors, and enables electronic batch records that ultimately enable real-time testing and release of the final product. ​A few examples include: ​

• An operations center, enabled by our software systems, monitors all aspects of front and back-end logistics, manufacturing planning and oversight ​
• Integrated pass throughs in each manufacturing suite enable rapid transfer of samples to the adjacent quality control laboratories.  ​

• A dedicated kitting area allows for all materials to be prepped, kitted, and transported to the appropriate processing suites. ​
• Two dedicated vestibules, one exclusively utilized for inbound patient/donor material and the second dedicated to the outbound product. ​
• We believe the Lykan manufacturing facility sets the standard for cell therapy manufacturing, and we intend to continuously improve the capability based on the future needs of our partners.