{"id":457,"date":"2022-03-21T14:37:55","date_gmt":"2022-03-21T14:37:55","guid":{"rendered":"https:\/\/lykan.dsstaging2.com\/?page_id=457"},"modified":"2022-05-31T16:30:16","modified_gmt":"2022-05-31T16:30:16","slug":"cell-therapy-cdmo-solutions","status":"publish","type":"page","link":"https:\/\/ms.ragersoul.com\/lykan\/cell-therapy-cdmo-solutions\/","title":{"rendered":"Services"},"content":{"rendered":"<\/a>
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Innovative CDMO Solutions For Cell-Based Therapies<\/h1>\t\t\t\r\n\t\t\t <\/div>\r\n\r\n\t\t <\/div>\r\n\t\t\t <\/div>\r\n <\/div>\r\n\r\n\r\n<\/div>\r\n <\/div>\r\n <\/div>\r\n\r\n<\/div>\r\n\n\n<\/a>
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Cell Therapy <\/span>Services Delivered with Passion<\/h2> \r\n
\r\n We are a partner focused and patient driven CDMO <\/div>\r\n <\/div>\r\n
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Transforming the Future Together\u00a0<\/strong><\/p>\n

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.<\/p>\n <\/div>\r\n\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n

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Cell Therapy <\/span>Services Delivered with Passion<\/p> \r\n

\r\n We are a partner focused and patient driven CDMO <\/div>\r\n <\/div>\r\n
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High-quality Standards to Meet Your Needs\u00a0<\/strong><\/p>\n

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.<\/p>\n <\/div>\r\n\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n

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Cell Therapy<\/span> Services Delivered with Passion<\/p> \r\n

\r\n We are a partner focused and patient driven CDMO <\/div>\r\n <\/div>\r\n
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\r\n \"orange\r\n <\/div>\r\n <\/div>\r\n
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Extensive Expertise in Cell Therapy<\/strong><\/p>\n

The Lykan team holds decades of biotechnology industry experience focused on the development and manufacture of cell-based therapies<\/p>\n <\/div>\r\n\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n

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Cell Therapy <\/span>Services Delivered with Passion<\/p> \r\n

\r\n We are a partner focused and patient driven CDMO <\/div>\r\n <\/div>\r\n
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Purpose-built cGMP Manufacturing Facility<\/strong><\/p>\n

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\u200b<\/p>\n <\/div>\r\n\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n

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Cell Therapy <\/span>Services Delivered with Passion<\/p> \r\n

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Innovative Platform Technologies\u00a0<\/strong><\/p>\n

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\u2019 projects<\/p>\n <\/div>\r\n\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n

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\r\n \"orange\r\n <\/div>\r\n <\/div>\r\n
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\r\n Transforming<\/span> the Future Together<\/span>\r\n <\/div>
\r\n High-quality Standards<\/span> to Meet Your Needs<\/span>\r\n <\/div>
\r\n Extensive Expertise<\/span> in Cell Therapy<\/span>\r\n <\/div>
\r\n Purpose-built<\/span> cGMP Manufacturing Facility<\/span>\r\n <\/div>
\r\n Innovative<\/span> Platform Technologies\u00a0<\/span>\r\n <\/div> <\/div>\r\n <\/div>\r\n <\/div>\r\n
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From Process Development to Clinical & Commercial Manufacturing<\/span><\/h2> \r\n <\/div>\r\n
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We provide end-to-end solutions for the development and manufacturing of autologous and allogeneic cell-based therapies<\/p>\n <\/div>\r\n\r\n\r\n\t\r\n<\/div>\r\n <\/div>\r\n\r\n \r\n<\/div>\r\n\n\n<\/a>

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Process Development <\/span>
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Our capabilities support the development and optimization of cell-based processes in line with phase-appropriate regulatory expectations <\/p>\n <\/div>\r\n \r\n \t

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Process Development <\/span>
and Optimization<\/h3> <\/div>\r\n \r\n \r\n <\/div>\r\n
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Analytical Development<\/span>
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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 <\/p>\n <\/div>\r\n \r\n \t

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Analytical Development<\/span>
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Technology <\/span>Transfer (MS&T)<\/h3> <\/div>\r\n \r\n
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Lykan\u2019s established MS&T capabilities ensure a smooth knowledge transfer from the partner to robust cGMP clinical manufacturing across all clinical phases, including commercial manufacturing <\/p>\n <\/div>\r\n \r\n \t

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Technology <\/span>Transfer (MS&T)<\/h3> <\/div>\r\n \r\n \r\n <\/div>\r\n
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Clinical and Commercial<\/span> Manufacturing<\/h3> <\/div>\r\n \r\n
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Clinical through commercial cGMP manufacturing\u202f(US\/EU) supported by Electronic Batch Records, Lykan provides capacity and capabilities to enable partners to deliver the product with the highest quality standard <\/p>\n <\/div>\r\n \r\n \t

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Clinical and Commercial<\/span> Manufacturing<\/h3> <\/div>\r\n \r\n \r\n <\/div>\r\n
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Supply Chain<\/span>
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Centralized management enables data security, real-time tracking, advanced preparation, and efficient mobilization of\u202f\u200bmanufacturing planning, execution, and product release activities\u200b <\/p>\n <\/div>\r\n \r\n \t

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Supply Chain<\/span>
and Logistics<\/h3> <\/div>\r\n \r\n \r\n <\/div>\r\n
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Quality<\/span> and Compliance<\/h3> <\/div>\r\n \r\n
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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<\/p>\n <\/div>\r\n \r\n \t

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Quality<\/span> and Compliance<\/h3> <\/div>\r\n \r\n \r\n <\/div>\r\n
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Project Management<\/span>
at Lykan Bioscience<\/h2> \r\n <\/div>\r\n
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Lykan\u2019s experienced project management team utilizes standardized processes and advanced technology to enable our partner\u2019s success.<\/p>\n <\/div>\r\n\r\n\t\t\t\t\t\t\t

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