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Innovative CDMO Solutions For Cell-Based Therapies

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Cell Therapy Services Delivered with Passion

We are a partner focused and patient driven CDMO
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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

We are a partner focused and patient driven CDMO
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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

We are a partner focused and patient driven CDMO
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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

We are a partner focused and patient driven CDMO
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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

We are a partner focused and patient driven CDMO
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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

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Transforming the Future Together
High-quality Standards to Meet Your Needs
Extensive Expertise in Cell Therapy
Purpose-built cGMP Manufacturing Facility
Innovative Platform Technologies 

From Process Development to Clinical & Commercial Manufacturing

We provide end-to-end solutions for the development and manufacturing of autologous and allogeneic cell-based therapies

Process Development
and Optimization

Our capabilities support the development and optimization of cell-based processes in line with phase-appropriate regulatory expectations

Process Development
and Optimization

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Analytical Development
and Optimization

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

Analytical Development
and Optimization

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Technology Transfer (MS&T)

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

Technology Transfer (MS&T)

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Clinical and 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

Clinical and Commercial Manufacturing

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Supply Chain
and Logistics

Centralized management enables data security, real-time tracking, advanced preparation, and efficient mobilization of ​manufacturing planning, execution, and product release activities​

Supply Chain
and Logistics

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Quality and Compliance

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

Quality and Compliance

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Project Management
at Lykan Bioscience

Lykan’s experienced project management team utilizes standardized processes and advanced technology to enable our partner’s success.

Discover More
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Innovative Cell Therapy Manufacturing Facility

We provide our partners with a leading-edge platform that combines innovative technology and know-how expertise

Cell Therapy Manufacturing Explained by Lykan Bioscience

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: ​

  • An operations center, enabled by our software systems, monitors all aspects of front and back-end logistics, manufacturing planning and oversight ​
  • Integrated pass throughs in each manufacturing suite enable rapid transfer of samples to the adjacent quality control laboratories.  ​
  • A dedicated kitting area allows for all materials to be prepped, kitted, and transported to the appropriate processing suites. ​
  • Two dedicated vestibules, one exclusively utilized for inbound patient/donor material and the second dedicated to the outbound product. ​
  • We believe the Lykan manufacturing facility sets the standard for cell therapy manufacturing, and we intend to continuously improve the capability based on the future needs of our partners.
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PARTNER-FOCUSED
PARTNER-FOCUSED
PARTNER-FOCUSED
PARTNER-FOCUSED

Interested in Cell Therapy CDMO Services?

Lykan Bioscience is a premier provider of development and manufacturing services

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