Polpharma Biologics

COMPANY PROFILE

Polpharma Biologics is an international biosimilars developer and CDMO with state‑of‑the‑art facilities across Europe dedicated to improving patient access to biologic medicines.

Description

Polpharma Biologics is a trusted developer and manufacturer of biosimilars operating across the European Union. The company is committed to broadening access to biological medicines through scientific rigour, speed to market, and high global quality standards. With a focus on global sustainability and transparent values, the firm provides both its own pipeline of biosimilars and contract development and manufacturing services to external partners. Centres of excellence in Poland and the Netherlands support technical development, clinical trials, and commercial-scale production.

Key Products and Services

Biosimilar pipeline
Polpharma Biologics maintains an expanding portfolio that includes biosimilar candidates to approved originator biologics such as ranibizumab, natalizumab, vedolizumab, and ocrelizumab. Several are at an advanced stage, including regulatory review by EMA and FDA.

Contract Development & Manufacturing (CDMO) services
The company offers integrated CDMO services across the full biologic development spectrum—from cell line creation, analytical and process development, through clinical operations, to GMP manufacturing and fill‑finish of both mammalian and microbial biologics. Their facilities are equipped for pre‑clinical, clinical, and commercial production.

Technical and clinical development support
Teams specialise in cell line generation, process development and analytical validation, followed by management of pre‑clinical and clinical trial activities to ensure safety and efficacy before regulatory submission.

European manufacturing footprint
Facilities are located in Gdańsk, Warsaw-Duchnice and Utrecht. Gdańsk hosts mammalian and microbial R&D and mid‑scale GMP manufacturing. Warsaw offers large‑scale mammalian production. Utrecht houses a proprietary cell‑line development platform.

Polpharma Biologics combines a strong internal pipeline of biosimilars with world-class CDMO capabilities to support both its own product development and the projects of external partners. Guided by values of integrity, transparency, and scientific excellence, it pursues its mission to deliver safe, affordable biologic therapies globally.

Certification
United States FDA, GMP

Capabilities

Contact Information

Address
Trzy Lipy 3 Building A, Gdansk Science & Technology Park, 80-172, Gdansk, Poland

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