The most comprehensive biosimilar capabilities in the industry
Our biosimilar capabilities are designed to help our partners provide patients worldwide with access to the most advanced life-saving and life-improving therapies available. We leverage our large molecule capabilities to develop biosimilars that have no meaningful difference from their reference product in terms of safety and efficacy and are more affordable than the originator drug. We also provide extensive expertise in cell line development, PQA modulation and process development to maximize reduce the overall cost of goods during development.
Cell Line Development to Global Supply Capabilities:
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.
Ready To Go 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 & 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.
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.
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.
From Cell Line to Global Supply
All of our development and manufacturing activities are done in-house, which greatly reduces risk and increases efficiency. Technology is transferred seamlessly from process development to clinical manufacture using the same or comparable equipment, and we have the flexibility to make quick, contextual decisions that best support a viable commercial strategy for for our partners. We want to get your product to patients as quickly as possible.