What We Can Do
Analytical Development (AD) allows for the determination of Critical Quality Attributes (CQAs) that are essential in monitoring the product from early process development to clinical and commercial manufacturing.
At Lykan, analytical methods, technologies, and regulatory requirements are continually evaluated for the purposes of product characterization. We support our partners by:
- Development of in-process and release analytics to support the Critical Process Parameters (CPPs) and CQAs
- Development, optimization, and validation of methods ranging from safety to potency, including flow cytometry, bioassays, q/ddPCR, ELISA, and cell-based assays
Fully Integrated Team
The Analytical Development team works closely with the Process Development (PD) and Manufacturing Science & Technology (MS&T) Teams during technology transfer to support the transfer and establishment of analytical methods at Lykan. The PD/AD/MS&T team plays a significant role in process implementation, process characterization, and the identification of CQAs and CPPs.
Lykan’s team has decades of biotechnology industry experience with different platforms, tools and technologies. Our internal capabilities include sterility and mycoplasma testing, cell counting assays, ELISAs, qPCR/ddPCR, flow cytometry, and potency assays, to name a few.
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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Lykan Bioscience is a premier provider of development and manufacturing services