CAPABILITIES & SERVICES - Lykan Bioscience

Capabilities & Services

What We Offer

With decades of biopharmaceutical industry experience in CGMP facility design, software, engineering, manufacturing and Quality operations, Lykan Bioscience provides the first true end-to-end solution for cell-based therapies, including shipping and logistics.

Our experienced team provides Process Development and CGMP manufacturing for autologous and allogeneic cell-based therapies in concert with our Quality Management System which serves the entire product lifecycle.

Lykan can meet your immediate needs with capacity availability and also offer long-term vision toward scalability, validation and high-throughput commercial manufacture of your cell-based therapies, whether they are CAR-T, TCR, TIL, iPSC, or other platforms.

Overview of Capabilities & Services:

Cell & Gene-Mediated Cell Therapy CGMP Manufacturing
- - Autologous and Allogeneic
  - Platforms: CAR-T, TCR, TIL, iPSC, etc.
Clinical through Launch to Commercial
Technology Transfer and Gap Assessment
Method & Process Development
Full Analytical Services
On-site Quality Control
On-site Quality Assurance
Method & Process Validation
CGMP Stability
Regulatory Support for filings and inspections
Ordering & Scheduling
Product Shipping and Logistics to / from Healthcare Providers
Client Dashboard Visibility
Long term storage in our Cell Pharmacy

Product Life Cycle Manufacturing

Through the combination of our SMART Manufacturing^TM Facility, Proprietary Electronic Data Management System and Operational Strategy, Lykan enables our Clients to get their products to patients most efficiently, and cost-effectively, with the highest quality.

Developed with our clients in mind, our proprietary software (EDMS) platform allows for timely access to data and integration of manufacturing data (e.g. testing, equipment, facilities, inventory).

The facilities, operation, QMS, paperless documentation and proprietary software support high-throughput manufacturing through real-time data collection & analysis, and rapid release, as they are designed and purpose-built to support the entire product lifecycle, from development through commercial production. Clients can avoid the time, cost & risk of a second transfer and comparability testing.

Defined process flows ensure product integrity (CoI & CoC) from receipt of Donor/Patient material through processing, storage and shipment from our Cell Pharmacy back to the Health Care Provider.

Manufacturing and logistics data are monitored 24/7 by the Lykan Team in our Operations Control Center. Clients will have direct, secure on-line visibility of product and process data (e.g. scheduling, process and testing data, status and logistics).

End-to-End Solution

Point-Of-Care

Health Care Provider Access

Ordering & Scheduling
Collection Process
Kitting & Labeling
Shipping and Logistics
Client Dashboard Visibility

Quality & Compliance

Right-First-Time

Full Product Cycle QMS
COI / COC Integrity Focus
Full QA/QC Services
Regulatory Support
Paperless Operations

Manufacturing

Best-In-Class

Flexible Capacity
High Throughput
CGT Experienced Staff
First of its kind SMART Facility
Optimized Process Flows

Operations Access

Client Timely Access

EDMS Data Collection & Integration
24/7 data monitoring by Lykan
Secure Client Data Dashboard
Operation by Exception
Real-time Lot Release

With our clients, we are Transforming the Future Together™, as we work collaboratively to provide new life-saving therapies to patients worldwide.

Quality & Compliance

Our focus is ensuring product integrity, while offering:

Close partnership with MS&T for method transfer, optimization, qualification & validation
Full-service Quality Control (QC) laboratories integrated with Operations
Quality systems support the product lifecycle, from first clinical runs through commercial production
In-house testing covers end-to-end including: incoming raw materials, IPC & final product testing
Capabilities include: core chemistry, analytical, and microbiological analysis (e.g.: compendial analysis, ELISA, rapid product sterility, microbial identification, spectroscopy).
Network of qualified contract testing laboratories to supplement in-house capability, if needed (examples: particulate analysis, container/closure integrity studies)
Support of facility and operational control via environmental, personnel, and utility monitoring
Lykan Quality Management Systems (QMS) are designed to accommodate client input and involvement:

- Quality agreements
- Client Turnover Package (TOP)
- Client approvals
- Regulatory inspection support
- Site Master File
- Client audits
- Person-in-Plant (PIP) program