Lykan’s 64,000 sq. ft. clinical and commercial manufacturing facility is located approximately 25 miles southwest of downtown Boston in Hopkinton, Massachusetts. The Lykan facility includes eight independent ISO 7 cGMP manufacturing suites, cGMP warehousing, and full-service cGMP quality control labs, all of which are surrounded by an innovative workspace for the Lykan team and our partners.
Process Development / Analytical Development Laboratories
Currently, the Lykan facility operates two configurable Process and Analytical Development laboratories supporting technology transfer and process development. An additional 1,700 sq. ft. state-of-the-art PD and AD lab is currently under construction and is expected to be completed in Q4 2021.
Operations Center
The Lykan facility operations center is staffed by a cross-functional team consisting of Operations, Quality, Manufacturing, Supply Chain and Facilities. This team continuously monitors the status of inbound and outbound logistics of patient material, product and test samples, production schedule, cGMP suite status and environmental conditions, production activities, and internal and external analytical testing.
Real time access to the status and arrival time of patient/donor material allows for timely preparation of manufacturing suites including operators, materials and equipment, to enable rapid mobilization once received.
Manufacturing
Lykan’s 4,800 sq. ft. cGMP, access-controlled warehouse operates a fully integrated electronic warehouse management system and provides significant ambient, refrigerated, and frozen storage capacity.
The Lykan facility has a dedicated incoming and outgoing product packaging and staging vestibules to maintain strict chain of custody/chain of identity protocols. Each of these areas have dedicated receiving and shipping bays which are separate from bays used for raw material receipt.
A dedicated kitting area enables efficient distribution of materials to the respective suite where cGMP processing will take place.
Lykan’s ISO 7 cleanroom core is surrounded by ISO 8 transfer corridors and contains eight fully isolated processing suites allowing simultaneous processing of multiple products. Each suite provides dedicated gowning and materials transfer rooms and a segregated central incubator farm to optimize the throughput of each manufacturing suite.
Each suite incorporates ISO 5 BSC’s for product manipulation while allowing efficient line clearance and equipment reconfiguration to meet our partners’ production needs.
Innovative Workspace
Lykan’s facility provides our team an innovative space. We provide dedicated, private offices for our partners while on-site supporting in-person collaboration and teamwork.
