What We Can Do
Lykan’s Process Development (PD) capabilities support the development and optimization of cell product manufacturing process in line with phase-appropriate regulatory expectations.
Our scientific team works closely with our partners to ensure a consistent, high-quality product throughout clinical development and commercialization by:
- Establishment of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
- Product comparability and stability studies with appropriate scaled-down models
- Process optimization including scale-up, automation and media/reagent optimization
- Optimization of unit operations to reduce handling frequency, open steps and cost while increasing yield
Begin with the End in Mind
We work with our partners to optimize their processes and recommend combinations of cell processing instruments and approaches, with the goal of improving product quality, step yields, and reducing manufacturing cycle times.
Our team works to transition open cell handling processes with manual manipulations, into closed, more automated formats as they become available.
Automation reduces contamination risks and ensures robustness and reproducibility by reducing operator involvement during cell selection, cell engineering, and cell expansion Unit Operations.
Partner Centric Approach
Lykan’s PD team supports the further development and optimization of cell product manufacturing processes in line with regulatory expectations that apply to specific phases of clinical product development.
Our PD team works closely with our partners to ensure that we understand their product, and we work with them to develop manufacturing strategies that can consistently lead to well-characterized, high-quality cell products.
Team Experience
Lykan’s team has decades of biotechnology industry experience with different platforms, tools and technologies. We support both autologous and allogeneic processes. Our experience includes CAR-T, iPSC, regulatory T cells, PBMCs, HSCs, Virus-specific T cells, Fibroblasts, and more.
The team’s experience is not only from a product development approach but also with a manufacturing background, ensuring a strong foundational knowledge for transfer into MS&T and clinical/commercial manufacturing.
Lykan’s team is dedicated to meeting our partners’ early- to late-stage development and clinical manufacturing needs and providing commercial manufacturing upon marketing authorization. Lykan’s partners will gain unparalleled attention, scalability, and flexibility that meet their current and future needs.
PD/AD Innovation Lab
Lykan has a dedicated laboratory space of 1,700 sq. ft available for process and analytical development. The PD/AD Innovation Lab is outfitted with the standard cell therapy processing technologies as well as innovative technologies at the forefront of the field. Our partners leverage our expertise in existing and emerging innovative cell therapy platforms.
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