Polpharma Biologics: Building on Early Achievements

Polpharma Biologics is a fast-growing unit within Poland, developing  and manufacturing new biopharmaceuticals as molecular entities (NMEs) or biosimilars, as well as delivering biopharmaceutical CDMO services. Established in 2013, Polpharma Biologics is already constructing its second manufacturing facility in Poland to provide customers with integrated support from cell-line development to the commercial-scale drug substance and drug product supply. 

Attractive Biologics Market

The global market for biopharmaceuticals is significant and growing at a healthy rate. Estimates for the worldwide revenue for biologics in 2018, including vaccines, range from $237 billion1 to $275 billion, and the biologics market is expanding at a compound annual growth rate (CAGR) of approximately 8.5% to reach $340 billion in 20232 and nearly $390 billion in 2024.3

The Business Research Company estimates there are currently more than 1000 biologic drugs in development and predicts that the U.S. Food and Drug Administration’s (FDA) focus on reducing time to market will lead to an increase in year-on-year growth of the biologics market from a recent 5.4% to 9.6%.4 In addition, the number of biotech patents applied for every year has been growing at approximately 23% annually, and more than 1,500 biomolecules are currently undergoing clinical trials.5 To date, the success rate for biologics in clinical trials has been over twice that of small molecule drug products. By 2022, biopharmaceuticals are expected to make up about half of the top-selling 100 products and about 30% of the prescription drug market.6

Furthermore, the global biosimilars market is expected to expand at a CAGR of 31.7% from $5.95 billion in 2018 to $23.63 billion by 2023.7 Currently, there are over 800 biosimilars in the global pharmaceutical pipeline.8 

Contributing factors to the growth of the biologics market include the approval of new products, expansions of indications for existing products, and increased demand stemming from the global growth of an aging population.1

Need for Integrated Services

The rapid growth occurring in the biopharmaceutical industry is creating significant demand for outsourcing services. A large percentage of innovation in the industry is driven by emerging and smaller biotech firms with limited resources.9,10 These companies often rely heavily on contract development and manufacturing organizations (CDMOs) that can provide integrated services across the entire development cycle from discovery to commercial launch. Even large biopharmaceutical companies are seeking the assistance of outsourcing partners with differentiated capabilities, including integrated services that enable accelerated timelines and reduced costs.

As such, the global biopharmaceuticals contract manufacturing market size is growing at an even more rapid rate than the biopharmaceutical market as a whole, with a $13.3 billion valuation in 2018 and projection to grow at a CAGR of 15.5% to reach $48.8 billion by 2027.11 

Polpharma’s Biologics Growth Strategy

Polpharma Biologics was established in 2013 by Polpharma, a privately owned, Polish pharmaceutical company producing small molecule generics and active pharmaceutical ingredients (APIs) largely for the Eastern European market, in response to the clear demand for both biosimilars and integrated biopharmaceutical contract development and manufacturing services. As one of the largest pharmaceutical companies in Central and Eastern Europe, the company leveraged its more than 80 years of experience producing generics and over-the-counter medicines and GMP/regulatory compliance and quality assurance to serve the biologics market. 

The first step in our strategy was to construct an 8,000-m2 Biotechnology Center in Gdansk for the development and optimization of both upstream and downstream bioprocesses in support of projects from conception through R&D, and on to production of clinical trial materials — in accordance with cGMP guidelines. The Center is outfitted with state-of-the-art equipment and staffed with a diverse team of world-class veterans with years of experience at big pharma companies and extensive collaboration with regulatory agencies.

The comprehensive R&D platform and GMP production capabilities include 2 x 1000-L single-use bioreactors for cell culture of clinical and small-scale commercial batches, a 500-L bioreactor for microbial fermentation and a flexible fill/finish line for use with vials, prefilled syringes and lyophilized products (5 million units per year), which will be operational by mid-2020. 

In addition to the CDMO services, Polpharma Biologics is developing biosimilars in-house up to the approval stage and then commercializing those biosimilars with the appropriate partners. This approach allows us to work on biosimilars that fit our capabilities without the need to focus on a single therapeutic area or justify sales in particular markets. Today, the company has five biosimilars in development.

We also offer contract development and manufacturing services based on our established competencies, and are interested in all types of deals — from fee-for-service to co-development, and beyond. The Biotechnology Center has the available capacity to support external client projects from development through clinical and small-scale commercial manufacturing and, starting in 2020, also large-scale manufacturing of drug substance and drug product out of our new site in Duchnice, near Warsaw. 

Initial Expansion through Acquisition

One of the keys to successful biologic drug production is the identification of optimized cell lines that are capable of production at high yields. High-yielding cell lines allow the use of smaller-scale upstream and downstream processing equipment — which minimizes capital expenditures — and the potential to produce fewer batches per year — which then reduces operating costs.

Polpharma Biologics developed the capability to engineer optimized cell lines with the acquisition of Bioceros in 2016. Bioceros’ well-established proprietary CHO BC® cell line development platform technology has been used for more than 25 years to generate high-yield production cell lines for both biosimilar and innovative proteins. The platform is complemented by a full range of cutting-edge high-throughput technologies to achieve the rapid generation of optimum, high-producing cell lines that meet specific quality attribute requirements. 

A comprehensive toolbox for targeted modulation of posttranslational modifications (PTMs) facilitates the development of proteins with fingerprint biosimilarity, which can be readily analyzed using robust in-house bioassays. Bioceros also possesses a wide range of advanced analytical capabilities, including mass spectrometry, state-of-the-art chromatography systems for clarification and purification and the custom design and execution of bioassays. 

With this suite of capabilities, it is typical for a client to have a locked-in “50-L process” ready for upscaling within 11 months.

The use of comparable — and, in many cases, identical equipment for research, development and production, combined with the collaboration between our manufacturing and development teams — including the sharing of analytical and bioassay development data — facilitates smooth and fast in-house transfer.

Large-Scale GMP Manufacturing Facility

Once the small-scale facility in Gdansk was completed, Polpharma turned its attention to establishing a large-scale commercial production plant. This facility is located in Duchnice, Poland, near Warsaw. The building has been completed, and the drug substance manufacturing line (2 x 2000-L bioreactors), including cleanrooms and utilities (as well as administrative offices), are currently under construction. Cleanrooms and utilities are also being installed for two additional production trains, allowing rapid expansion (within a few months) to 6 x 2000-L capacity as needed, without interrupting ongoing operations. Work will be completed in 2020, and technology transfer of the first product will take place in the third quarter of 2020. High-speed fill and finish lines have also been designed into the concept of this new site.

This facility will largely serve as a contract development and manufacturing site with mammalian and fill/finish technologies. Importantly, the technologies used for large-scale production are aligned with the technologies at all of our other facilities. The use of comparable — and, in many cases, identical equipment for research, development and production, combined with the collaboration between our manufacturing and development teams — including the sharing of analytical and bioassay development data — facilitates smooth and fast in-house transfer.

One-Stop Shop

With our two facilities in Poland and cell line development capabilities at Bioceros, Polpharma Biologics is able to provide truly integrated contract development and manufacturing services for both branded and biosimilar projects. Our capabilities span the full range from cell line, process and analytical development to GMP manufacture of drug substance and drug product that meet international quality standards.

Our modular one-stop-shop approach enables flexibility in terms of work packages and scope. We are happy to collaborate on integrated, end-to-end projects, or just one aspect of the development cycle. We are also able to readily scale with projects as they move from development to the clinic and commercial launch. As importantly, we provide a comprehensive range of services tailored to each individual project. 

Committed to Service

CDMO services from Polpharma Biologics are tailor-made for customers from all over the world for biosimilars and innovative molecules, including next-generation biologics, such as newer antibody frameworks.

Polpharma Biologics is dedicated to functioning as a true service provider. At the highest levels of the company, our goal is to collaborate with clients in order to help them accelerate the development and commercialization of life-improving and life-saving medicines. The company is 100% committed to supporting clients through the development process, including investment (with appropriate agreements in place) in additional capacity in response to evolving project needs. 

References

  1. Rader, Ronald A. and Eric S. Langer. “Biopharma Manufacturing Markets.” Contract Pharma. 8 May 2018. Web.
  2. Biopharmaceuticals Market - Growth, Trends, and Forecasts (2018 - 2023). Rep. Mordor Intelligence. Oct. 2017. Web.
  3. Biopharmaceuticals Market - Growth, Trends, and Forecasts (2019 - 2024). Rep. Mordor Intelligence. Feb. 2019. Web.
  4. “Faster Drug Approval Process Will Boost the Biologics Market.” The Business Research Company. 16 Apr. 2018. Web.
  5. Biopharmaceutical Contract Manufacturing Market: Oncology Segment by Therapeutic Area to Dominate the Global Market Through 2027: Global Industry Analysis 2012–2016 and Opportunity Assessment 2017–2027. Rep. Future Market Insights. 6 Sep. 2017. Web.
  6. Darby, Nigel. “Trends In The Biopharmaceutical Market: Are You Ready For The Future Of Manufacturing?” Water Online. 19 Jan. 2018. Web.
  7. “Biosimilars Market Worth 23.63 Billion USD by 2023.” Markets and Markets. 2018. Web.
  8. Langer, Eric S. and Ronald A. Rader. “CMOs & Biosimilars Mfg. in the U.S.” Contract Pharma. 2 Apr. 2017. Web.
  9. “Biopharmaceuticals Contract Manufacturing Market Worth $21.7 Billion By 2025.” Rep. Grand View Research. Sep. 2018. Web.
  10. Miller, Jim. “Pharma Outsourcing: Emerging Pharma Versus Big Pharma.” DCAT Value Chain Insights. 16 Jan. 2018. Web.
  11. “$48.8 Bn Contract Biomanufacturing Services Market, 2027.” IQ4I Research & Consultancy Pvt. Ltd. 28 Jan. 2019. Web.

Guenter Stempfer

At the end of 2016, Guenter joined Polpharma Biologics as Director of Technical Operations to build up an organization, capabilities and structure for production of Biopharmaceuticals. Since April 2019 Guenter was nominated to Managing Director Duchnice and board member of the respective investing companies. Guenter studied biology in Regensburg, Germany and graduated in the area of biochemistry in 1995.