Expanding scale and reach

One-stop shop CDMOs that offer a comprehensive portfolio of services supporting the entire biopharmaceutical development cycle have a clear competitive advantage. Ideally, such CDMOs are located where they can readily support the European and North American markets, which account for most of the consumption of biologic drugs.
In 2013, Polpharma Group started to establish state-of-the-art capabilities to support in-house and contract development of biopharmaceuticals. With more than 80 years of experience producing generics and small molecule medicines, and as one of the largest pharmaceutical companies in Central and Eastern Europe, Polpharma has extensive expertise in GMP/regulatory compliance and quality assurance to support such an endeavor in the EMA regulatory environment.
Polpharma Biologics, established as a division of Polpharma Group in 2013, today has a biopharmaceutical pipeline in advanced stages. Cell-line development capabilities were added in 2016 with the acquisition of Bioceros in the Netherlands. Polpharma Biologics is currently expanding its capability to produce final drug product (5 million vials/syringes per year) at its Gdansk facility. Construction of a commercial manufacturing facility at Duchnice, near Warsaw, is underway, which will eventually have 12 x 2,000-liter production trains and an annual fill-finish capacity of 30 million vials and syringes. Both expansions will be operational for drug substance and drug product manufacturing in 2019. 

Committed to quality, pace and cost-efficiency

Polpharma Biologics has been specifically structured as a European CDMO that serves global market needs and offers fully integrated solutions along the  development and production value chain for biologics and biosimilars. It provides fast, flexible, responsive service with a focus on mammalian cell culture and capabilities, spanning the full-range from cell line, process and analytical development to GMP manufacture of drug substance and drug product meeting international quality standards.
Low production costs have become compulsory to keep a project successful. High-yielding cell lines allow the use of smaller scale upstream and downstream processing equipment, resulting in reduced capital expenditure and the potential for fewer batches per year for lower operating costs. For more than 25 years, Bioceros has generated high-yield production cell lines for both biosimilar and innovative proteins through its proprietary CHO-BC® platform. It is complemented by a comprehensive toolbox for targeted modulation of posttranslational modifications to accomplish fingerprint biosimilarity, which can be readily analysed using robust in-house bioassays.
With its one-stop shop approach, Polpharma Biologics is positioned to provide a comprehensive range of services tailored to each individual project, including de novo process development, process optimisation, and manufacturing of fully developed processes.
Clinical manufacturing takes place at the Gdansk site, which houses bioreactors that contain volumes up to 1,000 or 2×1000 liters for cell culture and 500 liters for E. coli fermentation processes. Commercial GMP manufacturing using scale-down models, as well as high-throughput mini- and regular bioreactor systems for parallel screening will be operational at the new Duchnice facility by 2019. With up to 12×2000 liters disposable high-end production set-up, we represent the new benchmark within Europe in terms of cost of production and flexibility.

(First published in European Biotechnology, Autumn Edition 2017)