Biosimilar solutions

Cell line development

We take a different approach to other companies as we focus on delivering high titer cell lines and then tailoring upstream process modulation to match the given quality target product profile. This means you get biosimilarity without having to forgo high expression, significantly reducing upstream and downstream costs.

Biosimilar cell lines

We have developed a portfolio of high producing cell lines expressing biosimilar proteins, such as fusion proteins, enzymes and monoclonal antibodies which are available for out-licensing.

Analytics and bioassays

A typical biosimilar program at Polpharma Biologics begins with the development of more than 40 different analytical methods to deeply characterize the protein of interest and identify its core quality attributes. This process plays a crucial role in achieving biosimilarity of the final product.

Process development

We optimize both upstream and downstream processes to improve relevant quality attributes towards biosimilarity while maintaining high productivity. Over many years of experience, we have developed an innate understanding of process development and optimization through a series of multivariate experimental designs following Quality-by-Design (QbD) principles.

Manufacturing

Our state-of-the-art manufacturing facilities utilize the latest single use technology to produce drug substance and drug product for pre-clinical, clinical and commercial supply.