Analytical Development and Optimization

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.

Female Lykan employee using computer with gloves

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 and 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.

Once each analytical method is optimized, the method is then transferred into quality control, who completes method validation and routinely conducts each method to generate in process and final product testing data in support of clinical and commercial manufacturing.

Team Experience

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.

Lykan’s commitment to analytical innovation is driven by partnerships with leading academic institutions and innovative process solution providers. Analytical methodologies are critical to producing consistent, compliant, high-quality cell-based therapies.

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.