Clinical and Commercial Manufacturing

Clinical & Commercial Manufacturing

Lykan supports both clinical and commercial cell therapy manufacturing with flexibility and unparalleled attention to our partners. Our facility is adaptive to accommodate production of all cell therapy types; our operational systems and Quality Management System (QMS) serve clinical through commercial production with enough flexibility for early-stage partners and robustness for commercial partners.

Flexible and Customized Solutions

At Lykan we understand that every cell therapy program is different. We work with our partners to understand and meet their program objectives and timelines. Based on our extensive cell therapy experience, we collaborate with our partners on program solutions and opportunities.

Through the combination of our operational strategy, extensive experience and proprietary electronic data management system, Lykan enables our partners to deliver their product to patients efficiently, cost-effectively, and with the highest quality. Our manufacturing capabilities include:

Manufacturing Procedures: Cell Isolation, Cell Sorting, Cell Expansion, Washing, Volume Reduction, In-house Cryopreservation and Storage
Cell Therapy Type: Autologous, Allogeneic
Cell Types: CAR-T, iPSC, Regulatory T Cells, PBMCs, HSCs, Virus-specific T Cells, Fibroblasts, and More
Technologies: LOVO, CliniMACS Plus®, CliniMACS Prodigy®, SONY FX500 Exchangeable Fluidics Cell Sorter, Sepax, Xuri, Closed Systems, Sysmex, NC-200, NC-202, and More
In-house Testing: Real Time Testing and Release, Flow Cytometry, qPCR, Rapid Biological Methods (Endotoxin Sterility and Mycoplasma), Raw Material Testing, Stability Testing

Unparalleled Attention

Defined process flows ensure product integrity (Chain of Identity & Chain of Custody) from receipt of Donor/Patient material through processing, storage, and shipment from Lykan back to the Health Care Provider.

All manufacturing and logistics data are monitored 24/7 by the cross-functional Lykan Team in our Operations Command Center.

Lykan worker handling bioscience materials with gloves

Team Experience

Lykan’s team has decades of biotechnology industry experience with different platforms, tools and technologies. Members of our core manufacturing team are pioneers in cell therapy manufacturing and previously worked for companies that obtained FDA marketing authorization for cell-based immunotherapy products.

Lykan’s team is dedicated to meeting our partners’ early- to late-stage development and clinical manufacturing needs and providing commercial manufacturing upon marketing authorization. Lykan provides its partners with unparalleled attention, and flexibility to meet current and future needs.

The Manufacturing Facility

Lykan’s ISO 7 cleanroom core is surrounded by ISO 8 transfer corridors and contains eight independent processing suites allowing simultaneous processing of multiple products. Lykan is currently adding an additional eight cGMP suites in 2022, Lykan will have 16 cGMP Suites capable of US/EU clinical and commercial production.

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 BSCs for product manipulation while allowing efficient line clearance, concurrent manufacturing, and equipment reconfiguration to meet our partners’ production needs. Learn more about the purpose-built facility.