Cell line development to global supply capabilities:
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.Cell line development
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.Biosimilar cell lines
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.Analytics and bioassays
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.Process development
All the component to take your product from DNA, through IND and clinical trials and to support your global commercial supply. This includes antibody discovery, cell line development, process development and cGMP manufacturing supported by extensive analytical capabilities.
State of the art microbial manufacturing facilities for fermentation recovery & purification development through to cGMP manufacturing for preclinical, clinical and commercial supply.
Drug product development and cGMP manufacturing of sterile biologicals in liquid and lyophilized forms at lab and large-scale.