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Cell & Gene Therapy Analytical Services

Analytical support for cell & gene therapies

Precision and reliability are crucial for advancing cell and gene therapies. At SK pharmteco, we excel in analytical development and testing to ensure the safety, efficacy, and compliance of complex therapies.

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Analytical Development & Testing Services

Reliable, high-quality data inform every step of advanced therapy development and production. SK pharmteco equips partners with a full spectrum of support in cell and gene therapy analytical development, transfer, qualification, and validation, backed by cutting-edge instrumentation and specialized expertise. Our advanced therapy analytical services division provides clients with access to CGMP laboratory capabilities and direct support, eliminating the need to outsource to multiple laboratories. We’re uniquely positioned to build and execute analytical testing solutions that deliver faster results, prepare partners for regulatory submissions, and accelerate the path to market.

Custom Analytical Development & Advanced Analytics

SK pharmteco has advanced analytical capabilities, enabling cutting-edge testing approaches and rapid, accurate delivery of results. We collaborate closely with partners to select and develop phase-appropriate and product-specific assays or transfer and validate their methods. Analytical testing panels are customized for each AAV & lentiviral vector, plasmid DNA & nucleic acid, and cell therapy program. We can also support biologics, vaccines, and other advanced therapies.

Flexible Testing Solutions

SK pharmteco provides contract testing and analytical development for advanced therapies, allowing partners to simplify their outsourced testing strategy. Partners can access services as part of an end-to-end CDMO partnership or leverage our established analytical testing programs as a standalone offering.

Commitment to Quality

Our analytical approach encompasses global regulatory domains of safety, potency, purity, stability, and identity at every step, providing partners with phase-appropriate analytical solutions that deliver quality products. With deep expertise in the dynamic regulatory landscape of advanced therapies, we can help partners proactively navigate challenges in CMC procedures, prepare relevant documentation for regulatory submission, and more.

Explore Our Testing Platforms & Capabilities

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