LYKAN

SOLUTIONS

INDUSTRY CHALLENGES

LACK OF INNOVATION

1Design, engineering, and staffing innovations in the manufacturing systems that process patient-specific cell & gene therapeutics have not kept pace with other biotech research and development.

FACILITY DESIGN AND CAPACITY CONSTRAINTS

2Ad hoc customization of existing pharma manufacturing facilities has proven to be an inefficient & costly solution for biotech products; largely due to the small-batch, low-volume nature of targeted therapies vs. conventional drugs.

OPERATIONAL LIMITATIONS

3Traditional pharma manufacturing management and staff are not experienced in lowering labor intervention to reduce error rates, increase productivity, and drive down costs.

LYKAN

SERVICESCOMING SOON

Point-of-care

HEALTH CARE PROVIDER ACCESS

  • Patient Enrollment

    Patient enrollment is a crucial part of our overall operation. Patient enrollment must be seamlessly coordinated with the Scheduling and Manufacturing component. Our patient first focus allows us to efficiently enroll the patient while simultaneously scheduling all down stream operations. We provide our clients with full control of the enrollment process with our SW Module Connek and access to the Lykan Capacity Schedule via EDI.

  • Ordering and Scheduling

    True innovative end-to-end cell therapy requires a comprehensive view of the entire process; whether autologous or allogeneic. Our propriety capacity planning tools allow us to take an inclusive, wide angle view of the patient treatment, including their supply chain status.

  • Collection Process

    Patient and labeling verification is critical at this step in the process. Here the integration of COI and COC data is paramount in establishing and reporting patient identification, coding, and validation. Our Connek SW Module will guide the POC nurses throughout the entire collection process.

  • FP Administration Process

    Integration with the Quality Systems is key in determining Final Product (FP) assay and availability. Final entries into the batch record and FP Release Testing will typically trigger the FP release; scheduling the courier and notifying the administration facility for patient scheduling. Our Connek module performs these tasks with full automation capability.

  • COC / COI Dashboard Access

    A comprehensive view of all patients and their treatment process is of the utmost importance. At a time when the patient’s hope is greatest, accurate updates and notifications are an invariable asset to keep morale high. A comprehensive dashboard view allows all team members a means to better coordinate each patient's treatment. Our Akcess SW Module gives our clients a front row seat to our entire operation.

Tech Transfer

ESTABLISHING RELATIONSHIPS

  • OBL – Optimized Business Logic

    A successful cell therapy partnership requires an optimized process for tech transfer. The Lykan team has proven experience in both clinical and commercial applications, as well as business logic that supports the optimization of your process from clinical to commercial.

  • MPL – Manufacturing Process Logic

    With many new cell therapies and indications being introduced, the ability to rapidly prototype and benchmark the manufacturing process is fundamental for success. Lykan utilizes proven techniques for streamlining the process, as well as the required GMP software to support your project from clinical to commercial.

  • SOP Mapping

    Process mapping using SOP’s (Standard Operating Procedures) and application templates allows a thorough means to ensure all requirements are captured and identified for regulatory purposes. The Lykan team is comprised of industry experts who guide the overall cGMP process from an end user design basis to help map the overall SOP strategy.

  • EBR Design Logic

    EBR (Electronic Batch Record) design can be very challenging, especially with clinical trials. How can you optimize EBR creation when every process requires a rework and re-validation? By using application templates and modular design, Lykan can streamline the EBR design process and reduce validation to an incremental effort.

  • Timeline Driven Project Schedule

    The basis of a timeline-driven schedule is the ability to effectively and quickly respond to Change Management Events. Our capacity planning and scheduling abilities allow us to do so while also evaluating patient impact. When change occurs, the Lykan team will drive our efforts to minimize the effect on patient care.

Manufacturing

BEST-IN-CLASS

  • Flexible Capacity

    The Lykan process allows for the rapid set-up of multiple manufacturing procedures. This ensures the optimum response time wherever possible; including staffing levels, manufacturing equipment, and varying process steps. Whether for a clinical trial or supplementing commercial production capacity, we have the solution.

  • Equipment Technology

    Lykan is fully experienced with most CGT equipment. From a manual process to a more computerized device, we can handle it. Working directly with our partners, we are fully engaged to access and utilize new equipment and technologies as they becomes available.

  • CGT Trained Staff

    To meet regulatory requirements as well as keeping abreast of new technology, we take great pride in keeping our staff fully trained in the latest CGT solutions and procedures.

  • First of it's kind Smart Facility

    Lykan has optimized the manufacturing process while simultaneously improving the quality and consistency of the product. We did so by designing and building a facility to specifically address the needs of CGT Manufacturing. This allows us to reduce costs at every turn and shorten the time it takes treatments to reach the patient.

  • Optimized Process Flows

    The Lykan team has optimized the manufacturing flow to ensure the safety and efficacy of the CGT product while still ensuring reproducibility to meet quality and validation standards throughout the manufacturing process. Automated processes such as Deviation Management also ensure that any concerns are dealt with in a timely and comprehensive manner.

Operations Access

CLIENT REAL-TIME ACCESS

  • Manufacturing

    Running multiple product batches on critical equipment requires a comprehensive and timely view of all operations. Using our internal SW Module Dash allows Lykan to view all of our Manufacturing Operations to ensure the timely delivery of the finished product to the patient.

  • Material Inventory

    Managing material including the creation of kits is challenging for most. Tracking components and expiration dates requires integration with multiple applications including ERP, MRP, and many others. The Lykan platform allows this integration to occur seamlessly.

  • Document Library

    Ensuring that all content is current and properly managed, companies require an Enterprise Content Management (ECM) application. With help from our partners, Lykan delivers the best in class offerings configured for CGT implementation, providing our clients with access to their entire document library.

  • Reports

    The automated report generation being developed as part of the Lykan platform is supported by the CGT Data Model. The reports are integrated with the processing logic module to ensure that all records are completed; allowing for automated downstream processing which is specifically critical for batch records.

  • Client Dashboard

    In order to optimize patient scheduling, supply chain, patient treatment, and associated support, a client dashboard overview is critical — and in many cases life saving. The ability for both client and patient to visualize and determine the status of the treatment product, permits an easier method for treatment scheduling as well as family and support logistics. An intuitive and easy to comprehend dashboard is critical, and we will provide our clients with full visibility of their entire process.

Quality Program

RIGHT-FIRST-TIME

  • Full Document TOP

    A well-documented and comprehensive turn over package (TOP) is vital when it comes to formalizing the batch release process. The orchestration of manufacturing and quality measures are key in getting the final product released and notifying the courier in a timely manner. Our SW package manages this task seamlessly.

  • Quality KPI’s

    A dashboard view of all Quality Key Performance Indicators is instrumental in optimizing the flow of the quality and manufacturing process. This includes all quality items such as the QC release of the incoming material to the assay, final batch release, and other processes. Our clients will have real time access to these KPI's.

  • Material Testing

    The diverse range of materials used in CGT Manufacturing requires a well-rehearsed process to ensure all material is well qualified. Lykan supplies a state of the art lab to evaluate the purity, potency, and quality; from raw material to finished product.

  • COI / COC TOP

    Needless to say, confirming patient identity and tracking product custody are required to meet regulatory requirements. Of equal importance is the ability to accurately forecast when the patient treatment will arrive for administration. Our clients will have full access to real time reports for COI/COC.

  • Product Release Testing

    Integration with quality systems and product release are vital to maintain a streamlined process. Product characterization and mechanism of action do not fully describe the complexity of an acceptable assay. Lykan has experience in evaluating the additional biologic factors that are required for fully characterizing a product’s release.

Supply Chain MGT

FULL OVERSIGHT AND CONTROL

  • Logistics Automation

    The primary benefit of logistics automation allows us to evaluate available logistics choices in real-time. By eliminating manual entry and its associated errors, we can quickly determine the most efficient product route.

  • Product Tracking

    When time really matters, a means for monitoring the final product is required for scheduling as well as reassuring for the patient. We supply a very simple means to monitor and hone in on the treatment process while also publishing email notifications to all involved entities.

  • Inventory Control

    Efficient inventory control will rely on integration with key applications including MRP and ERP, to maintain proper stock level. We fully understand the value of an integrated set of applications to manage inventory.

  • Final Product Storage

    Considerations like shelf life and temperature storage are key manufacturing requirements specified as part of the product and batch record. This includes our on-site product storage as well as tracking courier parameters and cold chain management.

  • Material Management

    A key component of the Lykan process is our ability to quickly create a CGT Manufacturing environment specific to a client’s requirements. From purchasing and vendor partnership to cGMP manufacturing and finished product, we engineer the entire life-saving process.

LYKAN

Operations Management

Accelerate time to Market

1Lykan deploys a work breakdown structure (WBS) in its project management and systems engineering processes; simplifying each manufacturing project into essential deliverables to better organize the workload into manageable segments. This gives us the ability to optimize project execution and work in parallel paths, reducing our project timelines by months while still delivering exceptional results.

Optimize Capacity Management

2Our understanding behind capacity management allows us to optimize capacity utilization based on asset management and staff allocation. This creates incredible flexible capacity in a 365/24/7 operation.

Create Efficient Scalable Manufacturing Process

3Lykan has the unique ability to break down client processes by taking a lab scale approach and turning it into an efficient scalable manufacturing process. We can leverage process automation & standardization to identify and address bottlenecks; ensuring cycle time reduction, maximizing staff utilization, and increasing yield of manual processes.

LYKAN

Quality by Design Program

Control

1Greater end-to-end control over production that results in dramatically improved predictability towards product safety.

Product Lifecycle

2Streamlined product lifecycle management and associated interactions with regulatory authorities, from clinical to commercial launch.

Continuous Improvement

3A substantial foundation for continuous process improvement, coupled with more rigorous and efficient corrective actions and preventive measures.

Transparent and Audit Ready

4Significantly greater control over inspections and audits, with findings that are lower in impact and fewer in number.

LYKAN

Operational Excellence

Cost of Quality

1The driving forces come from every department in the company. By evaluating and auditing our products, processes, and services, we assure conformance to quality standards and performance requirements.

Process Optimization

2We have the unique ability to access our client process by designing an initial business logic which identifies bottlenecks within the process and provides us with opportunity to implement more efficient changes.

Transparency

3Through our Akcess Module we provide our clients with full viewing access to their operational dashboards, KPI and project status overview.

Get in touch

Collaboration is key to success in any endeavor; we are much stronger together as a team. Contact Lykan Bioscience today and take the first step towards the future of cell and gene therapy.

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