Slide Capabilities & Services

Lykan provides Analytical Development, Process Development and cGMP clinical and commercial manufacturing for autologous and allogeneic cell-based therapies underpinned by our comprehensive Quality Management System which serves the entire product lifecycle.

Lykan is well-positioned to meet your near-term clinical or commercial manufacturing requirements and is fully prepared to expand our cGMP footprint to meet mid to long-term needs of our partners including dedicated manufacturing capacity.

Overview of Capabilities & Services:

  • cGMP Manufacturing
      • Autologous and Allogeneic manufacturing processes
      • Platforms: CAR-T, TCR, TIL, iPSC, NK, etc.
      • Clinical through commercial manufacturing
  • Technology Transfer and Gap Assessment
  • Analytical Method & Process Development
  • Quality Control
  • Quality Assurance
  • Method & Process Validation
  • cGMP Stability
  • Regulatory support for filings and inspections
  • Product Shipping and Logistics

Process Development & Analytical Development

Lykan’s Process Development and Analytical Development capabilities support the development and optimization of cell-based processes. Our scientific team works closely with our partners to optimize their process in order to comply with phase-appropriate regulatory guidelines and ensure a consistent, high-quality product throughout clinical development and commercialization.

 

For partners with earlier stage processes, we work to improve their processes and recommend combinations of cell processing instruments and approaches, with the goal of improving product quality, step yields, and reducing manufacturing cycle times. Our team works to transition open cell handling processes with manual manipulations, into closed, more automated formats when possible. Automation reduces contamination risks and ensures robustness and reproducibility by reducing operator involvement during cell selection, cell engineering, and cell expansion Unit Operations. When possible, we recommend optimal chemically-defined media formulations to remove serum from cell culture steps. The Process and Analytical Development team transfers the developed process to the Manufacturing Sciences and Technology team, who then facilitates the transfer into the cGMP manufacturing facility.

Technology Transfer

Lykan’s Manufacturing Science and Technology team has decades of experience in development and commercial stage cell therapy process technologies and analytics. We take a comprehensive approach to technology transfer that begins with a detailed assessment of your manufacturing processes, testing requirements, and development stage. By evaluating the steps needed to efficiently implement cGMP production, we work to identify opportunities to optimize processes as they move toward commercialization. This multidisciplinary assessment by experts in cell therapy manufacturing provides a thorough project plan to meet our partners’ timelines.

Lykan has dedicated laboratory space available for PD, AD, technology transfer, engineering runs, and training, as well as office space for visiting partners for in-person collaboration. Our partners leverage our expertise in common and emerging cell therapy equipment platforms to evaluate opportunities for process improvement and/or new product development.

Clinical & Commercial Manufacturing

Through the combination of our Operational Strategy and Proprietary Electronic Data Management System, Lykan enables our Partners to deliver their products to patients efficiently, cost-effectively, and with the highest quality.

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 Center.

Quality & Compliance

Lykan’s 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. Our QMS is ICH-compliant and managed by a team with significant PAI and routine cGMP inspection experience. Designed to include client collaboration, review, and approval, we offer:

  • Quality agreements
  • Client Disposition Package
  • Client approvals of project-specific cGMP documentation
  • Regulatory inspection support
  • Client audits
  • Person-in-Plant (PIP) program

Our experienced Quality Assurance (QA) team is integrated with the facility and manufacturing teams and the QMS is part of Lykan’s paperless environment. This real-time access to the facility, production and testing gives full transparency to QA which allows for close oversight, review of processes and issue resolution.

The QC team maintains a close partnership with our Manufacturing Science and Technology team for method transfer, optimization, qualification, and validation. Our comprehensive QC laboratories are located directly adjacent to manufacturing for rapid deployment of cGMP testing. Capabilities include:

  • Core cell therapy methods including: qPCR, rapid micro methods, flow cytometry, ELISA, automated cell counting
  • Incoming raw material, in-process and final product testing
  • Network of qualified contract testing laboratories to supplement in-house
    capability for USP Sterility and other methods, as required
  • Environmental, personnel, and utility monitoring