Transforming the Future Together
We offer a communicative, collaborative approach to working with our partners to meet project milestones, solve problems that may arise, and deliver on time. Together, with our partners, we strive to provide life-saving therapies to patients worldwide.
Cell Therapy Services Delivered with Passion
High-quality Standards to Meet Your Needs
Our Quality Management System (QMS) and Quality Control (QC) programs have been developed to ensure product quality while offering the flexibility needed to support manufacturing for all phases of development and commercialization.
Cell Therapy Services Delivered with Passion
Extensive Expertise in Cell Therapy
The Lykan team holds decades of biotechnology industry experience focused on the development and manufacture of cell-based therapies
Cell Therapy Services Delivered with Passion
Purpose-built cGMP Manufacturing Facility
State-of-the-art, purpose-built cGMP manufacturing facility, and process innovation/development laboratories. 16 cGMP Rooms by 2022 to support US & EU clinical & commercial production
Cell Therapy Services Delivered with Passion
Innovative Platform Technologies
We are committed to assessing and offering innovative processing and analytical platforms to enable the delivery of cost-effective, compliant cell-based therapies to patients in need, and maximize the potential of our partners’ projects
We provide end-to-end solutions for the development and manufacturing of autologous and allogeneic cell-based therapies
Our capabilities support the development and optimization of cell-based processes in line with phase-appropriate regulatory expectations
We can develop, optimize, and validate analytical methods ranging from safety panels to client-specific assays, including potency assays, to ensure successful analytical method transfer into QC
Lykan’s established MS&T capabilities ensure a smooth knowledge transfer from the partner to robust cGMP clinical manufacturing across all clinical phases, including commercial manufacturing
Clinical through commercial cGMP manufacturing (US/EU) supported by Electronic Batch Records, Lykan provides capacity and capabilities to enable partners to deliver the product with the highest quality standard
Centralized management enables data security, real-time tracking, advanced preparation, and efficient mobilization of manufacturing planning, execution, and product release activities
Our Quality Management System (QMS) and QC programs ensure product quality meets US & EU Regulatory Standards for Cell Therapy Products (ATMPs) while offering the flexibility to support clinical and commercial manufacturing
Lykan’s experienced project management team utilizes standardized processes and advanced technology to enable our partner’s success.
We provide our partners with a leading-edge platform that combines innovative technology and know-how expertise
Lykan is an organization that is committed to assessing and offing innovative processing and analytical platforms for cell therapy manufacturing. This is achieved through partnerships with academic institutions and industry-leading process solution providers to identify and beta test optimal cell therapy tools and platforms.
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:
Lykan Bioscience will help your development and manufacturing needs
