Draft:Mabion
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Comment: In accordance with the Wikimedia Foundation's Terms of Use, I disclose that I have been paid by my employer for my contributions to this article. Mabion CDMO (talk) 10:24, 24 April 2025 (UTC)
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| Company type | Private |
|---|---|
| GPW: MAB | |
| ISIN | PLMBION00016 |
| Industry | Biopharmaceutical |
| Founded | 2007 |
| Headquarters | Konstantynow Lodzki , Poland |
Key people | Krzysztof Kaczmarczyk (CEO) |
| Services | Drug substance manufacturing, Fill & finish, Process development, Analytical testing and method development, Regulatory support, Cell line development & banking |
| Revenue | 151 mln PLN (2023) |
| 55.1 mln PLN (2023) | |
| 41.3 mln PLN (2023) | |
| Total assets | 208.3 mln PLN (2023) |
| Total equity | 117.8 mln PLN (2023) |
Number of employees | 226 (2023) |
| Website | www.mabion.eu |
| Footnotes / references Financials as of 2023.[40] | |
Mabion is a biopharmaceutical company providing contract development and manufacturing services related to biologic drugs (biologics CDMO). It is headquartered in central Poland.[1][2][3]
Mabion was founded in 2007 as a biosimilar developer, but following the outbreak of COVID-19 pandemic it was transformed into a full scale CDMO.[3][4] The company is most known for its long-term collaboration with Novavax (initiated in 2021) on manufacturing and quality control of the protein-based COVID-19 vaccine, Nuvaxovid.[5][6][7]
Services
[edit]As a biologics CDMO, Mabion provides the following services:
- Drug substance manufacturing[8]
- Drug product manufacturing (fill and finish)[9]
- Bioprocess development[10]
- Analytical method development and quality control[11]
- Cell line development and banking.[12]
The company is focused mainly on the production of monoclonal antibodies and vaccine antigens, though its capabilities include also other types of recombinant biotherapeutics.[8][13]
Manufacturing processes at Mabion utilize both mammalian and insect expression systems (Chinese Hamster Ovary and baculovirus-transfected Sf9 cells, respectively).[8][14]
History
[edit]Mabion was established in April 2007 as a joint venture between the four major Polish pharmaceutical companies: Celon Pharma, Polfarmex, IBSS Biomed and Genexo.[15] Initially operating as a research and development company, Mabion focused on creating biosimilar versions of monoclonal antibodies such as rituximab, cetuximab, denosumab, omalizumab and trastuzumab.[14][16][17]
The company was also working on the development of innovative therapies for multiple sclerosis (MabionMS) and several rare diseases such as autoimmune hemolytic anemia (AIHA).[17][18] The developed treatments included low-dose rituximab products, used alone or in combination with existing immunomodulatory drugs. In 2023 Mabion managed to obtain FDA orphan drug designation (ODD) for two rare diseases: autoimmune hemolytic anemia and membranous glomerulonephritis.[19][20]
Development of MabionCD20 (rituximab biosimilar)
[edit]The most advanced biosimilar developed by Mabion that reached the drug registration phase in the EU is MabionCD20. MabionCD20 is a biosimilar to rituximab, an anti-CD20 monoclonal antibody used in the treatment of multiple autoimmune and oncological diseases.[21][22] Two Phase III clinical trials comparing MabionCD20 to the reference product, MabThera, were performed by Mabion in rheumatoid arthritis (MabionCD20-001RA, MABRA) and non-Hodgkin’s lymphoma (MabionCD20-002 NHL, MADILYM).[23][24] At the time of its completion, MABRA was the largest biosimilar trial ever performed, enrolling 709 participants. Both trials met the primary endpoints demonstrating similarity of the candidate biosimilar to the EU originator with respect to pharmacokinetics and efficacy.
In June 2018 Mabion submitted to the European Medicines Agency (EMA) a marketing authorization application for MabionCD20.[25] The process advanced through almost all review stages, but in early 2020 the application was voluntarily withdrawn pending additional clinical studies.[26] Due to the shift in business strategy and COVID-19 pandemic, the rituximab biosimilar project was put on hold in 2021. However, it remains available for potential reactivation or out-licensing.[27][28]
Transition into CDMO
[edit]Following the withdrawal of MabionCD20 application and onset of COVID-19 pandemic, Mabion changed the business profile from biosimilar developer to a CDMO. The plan for full transition was formally announced in April 2023.[28]
According to the company, the strategy shift was motivated by successful cooperation with Novavax on manufacturing and quality control of its COVID-19 vaccine, Nuvaxovid as well as increasing demand of the pharmaceutical market.[29] The contract between Mabion and Novavax was signed in March 2021 and involved the manufacturing of recombinant SARS-CoV-2 spike protein (rS) in baculovirus expression system.[7][30] The cooperation expanded over time to include: feasibility and analytical method transfer (January 2022), testing of the drug product (May 2022), stability studies for intermediate products and process solutions (June 2022), stability studies of drug substance (August 2022) and peptide mapping of drug substance and drug product of in-house and samples from other facilities (November 2022).[7] As of May 2025, Mabion continues to serve as Novavax’s CDMO.
Beyond Novavax, Mabion has entered into multiple CDMO contracts with other pharmaceutical companies.[31] On April 14, 2025, Mabion announced the start of cooperation with Instituto de Biologia Molecular do Paraná (IBMP), a Brazilian institution developing and producing pharmaceutical products, including biotherapeutics, for the local healthcare system. Under the new agreement, Mabion will assist IBMP in bioprocess development as well as clinical- and commercial-scale manufacturing of an undisclosed biosimilar.[32][33][34]
On the same day, Mabion also announced the beginning of strategic partnership with Sartorius AG.[35][36] The two companies will offer integrated range of services with Sartorius AG taking care of cell line development and upstream process optimization, and Mabion focusing on further development of upstream processes, downstream process optimization, validation of analytical methods, scale-up with process characterization and finally large-scale manufacturing services.[36]
Business operations
[edit]
Mabion’s manufacturing facility is located in Konstantynow Lodzki, Poland, which lies near Lodz, the third biggest city in Poland. Another facility, reserved for bioanalytical laboratories, is located in Lodz.[3]
As of 2025, the company has 226 employees, which include mainly biotechnology, biochemistry, pharmacy and microbiology professionals.[37]
To meet the growing market demand, Mabion has announced plans to increase its capacity by 2030 by expanding the existing facility and installing additional 2,000 L bioreactors.[8]
As of April 2025, the CEO of Mabion is Krzysztof Kaczmarczyk.[38]
Financials
[edit]Mabion has been publicly listed on the Warsaw Stock Exchange (GPW) since 2013.[39]
Annual financial table (all values in PLN).[40]
| # | 2019 | 2020 | 2021 | 2022 | 2023 |
| Sales/Revenue | - | - | 56.87 mln | 163.98 mln | 151.68 mln |
| Net income | -63.74 mln | -55.77 mln | 1.9 mln | 23.19 mln | 41.27 mln |
| Total current assets | 40.3 mln | 11.77 mln | 82.39 mln | 82.18 mln | 90.45 mln |
External recognition
[edit]In March 2025, Mabion was recognized as the champion of the 2025 International CDMO Leadership for Biologics.[41]
References
[edit]- ^ "Mabion: Your Biologics CDMO". Bioprocess Online. 2024.
- ^ "Mabion company profile". Contract Pharma.
- ^ a b c "Mabion's home page". Mabion.
- ^ "Mabion S.A. Directors' Report for the first half of 2023". Mabion. 2023.
- ^ "Mabion SA: An introduction to a leading Polish biotechnology company". Laborant.pl.
- ^ "MABION S.A.: Zawarcie umowy ramowej wraz z pierwszym zamówieniem na usługi kontraktowe z Novavax, Inc. w zakresie programu szczepionki na COVID-19". Bankier.pl (in Polish). 2021-03-03. Retrieved 2025-04-24.
- ^ a b c "Novavax and Mabion Partnership on COVID-19 Vaccine". Mabion. Retrieved 2025-04-24.
- ^ a b c d "Drug Substance Manufacturing of Biologics, Drug Product Development". Mabion. Retrieved 2025-04-24.
- ^ "Sterile Fill and Finish for Biologics Drug Product". Mabion. Retrieved 2025-04-24.
- ^ "Biologics Process Development, Bioprocess, Drug Development". Mabion. Retrieved 2025-04-24.
- ^ "Bioanalytical Services, Quality Control of Biologics". Mabion. Retrieved 2025-04-24.
- ^ "Cell Line Development & Banking". Mabion. Retrieved 2025-04-24.
- ^ "About Mabion SA". cphi-online.com. Retrieved 2025-04-24.
- ^ a b Czubek, Edyta E. Bartusik; Czubek, Bartłomiej M.; Toboła, Paulina E.; Lonkwic, Karolina M.; Miłek, Piotr P.; Grzyb, Olga H.; Balcerek, Julita A.; Pietrucha, Tadeusz; Jaros, Sławomir (2023). "The CHO cell line as a potentially safer host for cetuximab therapeutic antibody production than the Sp2/0 cell line". International Journal of Biotechnology. 14 (4): 277–292. doi:10.1504/IJBT.2023.138705. ISSN 0963-6048.
- ^ "History". Mabion. Retrieved 2025-04-24.
- ^ "Mabion Signed An Agreement For The Realization Of A Clinical Trial Of The Drug MabionHER2". BioSpace. 2014-09-23. Retrieved 2025-04-24.
- ^ a b "Presentation for investors 2019" (PDF). Mabion. 2019.
- ^ "Mabion z drugim wnioskiem patentowym w obszarze innowacyjnej terapii na MS". kierunekfarmacja.pl (in Polish). Archived from the original on 2025-01-20. Retrieved 2025-04-24.
- ^ "Orphanet: Mabion SA". orpha.net. Retrieved 2025-04-24.
- ^ "Search Orphan Drug Designations and Approvals". FDA. Retrieved 2025-04-24.
- ^ "MabionCD20 | Mabion SA | CPHI Online". cphi-online.com. Retrieved 2025-04-24.
- ^ "Rituximab biosimilar - Mabion". Adis Insight.
- ^ Mabion SA (2020-05-13). A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis (Report). clinicaltrials.gov.
- ^ Mabion SA (2023-01-11). Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 Compared to MabThera (Rituximab by Hoffman-La Roche) in Patients With Diffuse Large B-cell Lymphoma (Report). clinicaltrials.gov.
- ^ "Mabion S.A. completes marketing authorization application for flagship drug, MabionCD20, to the European Medicines Agency (EMA) | Plexus Ventures". Retrieved 2025-04-24.
- ^ "Mabion withdraws application for rituximab biosimilar in EU". gabionline.net. Retrieved 2025-04-24.
- ^ "Other information to the quarterly report of Mabion S.A. for Q32022" (PDF). Mabion. 2022.
- ^ a b "Strategy for 2023-2027 Presentation for investors" (PDF). Mabion. April 2023.
- ^ "Novavax deal with Mabion boosts Poland's nascent biotech scene". Bloomberg. 2021-03-03.
- ^ "Polish firm Mabion set to produce Novavax COVID-19 vaccine". tvn24.pl (in Polish). 2021-03-03. Retrieved 2025-04-24.
- ^ "Mabion zrealizuje dla nowego klienta z Wielkiej Brytanii zlecenia CDMO o wartosci ok. 55 mln PLN" (PDF). Mabion. January 2025.
- ^ "Mabion and IBMP Enter Strategic Partnership for Biosimilar Development with Sartorius as Key Technology Partner". Biopharma Boardroom. 2025-04-17.
- ^ "Mabion to fulfill CDMO orders for a new client" (PDF). Mabion. April 2025.
- ^ "O IBMP". IBMP (in Brazilian Portuguese). Retrieved 2025-04-24.
- ^ MarketScreener (2025-04-14). "Mabion Signs Strategic Cooperation Deal With Sartorius | MarketScreener". marketscreener.com. Retrieved 2025-04-24.
- ^ a b "Sartorius and Mabion announce strategic cooperation to advance biopharmaceutical development" (PDF). Mabion. April 2025.
- ^ "Mabion SA, MAB:WSE profile - FT.com". markets.ft.com. Retrieved 2025-04-24.
- ^ "Company bodies". Mabion. Retrieved 2025-04-24.
- ^ Interactive, SUPERMEDIA. "GPW Main Market - Company factsheet". gpw.pl. Archived from the original on 2021-07-24. Retrieved 2025-04-24.
- ^ "MAB.PL | Mabion S.A. Financial Statements - WSJ". The Wall Street Journal. Retrieved 2025-04-24.
- ^ Thakur, Tamnna (2025-03-20). "Mabion Wins International CDMO Leadership Award in Biologics at DCAT Week". PharmaSource. Retrieved 2025-04-24.