Aeterna Zentaris GmbH

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3P Biopharmaceuticals

Headquarters Polígono Mocholi, Plaza Cein, 1 31110 Noáin Spain

Manufacturing site Polígono Mocholi, C/Mocholi, 2 31110 Noáin Spain

Elena Erroba (Business Development Director) +34-948-34-64-80 withinus@3pbio.com www.3pbio.com

LI

300+

| Biotechnology | Biomedicine | CDMO | End to hand | Biologics | GMP | Recombinant Proteins | Cell Therapy

Company profile

3P Biopharmaceuticals is a Contract Development and Manufacturing Organisation (CDMO) specialised in process development and GMP manufacturing of biologics and cell therapy products using microbial and mammalian-based expression technologies. 3P is a robust manufacturing partner with a successful global track record and a highly qualified team that accompanies clients through the full life cycle of their products from cell line development through to clinical and commercial manufacturing. In its state-of-the-art biomanufacturing facilities, the company also offers a comprehensive range of in-house analytical and development services as well as continuous regulatory support that improves the value of its client’s drug candidates.

GMP certified

3P Biopharmaceuticals offers GMP manufacturing services for biologics.

GMP certified & FDA approved for: › API manufacturing (clinical trials & commercial production) › QC and release of API and final products for clinical trials and commercial supply

Highest Quality Standards

3P ensures the highest level of quality excellence and compliance with regulatory requirements.

Summary services

› Cell line development and GMP cell banking › Process development and optimization › Analytical methods development, qualification & validation › Scale-up and cGMP manufacturing › DS & DP release › Process characterisation & validation › Commercial manufacturing › Tech transfer › Comparability studies › Formulation development

Advanced therapies

› Cell therapy products › Tissue-engineered products › Biomaterials (scaffolds or membranes)

Biologics facilities & equipment

Process development capacities for mammalian: › Ambr 250® › Ambr 15® › BIOSTAT® Qplus 6 fold (6x1 L) › BIOSTAT® B-DCU II 2fold 5 L (2 x5 L) › BIOSTAT® B twin 5 L (2x5 L)

Process development capacities for microbial: › BIOSTAT® B twin 2 L (2x2 L) › BIOSTAT® B twin 2 L (2x2 L) › BIOSTAT® B-DCU II 3fold (2x2 L + 1 x 10 L) › BIOSTAT® Cplus 10 L (Stainless steel biorreactor)

GMP Manufacturing capacities for mammalian: › Single use bioreactors: 50 L, 200 L, 400 L, 2000 L

GMP Manufacturing capacities for microbial: › Stainless steel bioreactors: 2x10 L, 3x100 L, 1000 L

Track record

3P is involved in GMP manufacturing projects starting from gene design up to commercial manufacturing bringing its clients on board at all stages of development. 3P works with various microbial and mammalian expression systems and has extensive experience in process development and GMP manufacturing of New Biological Entities (NBEs) including fusion proteins, vaccines, monoclonal antibodies, antibody fragments and other recombinant proteins as well as being specialised in biosimilar development and production. The company has a proven approach for the execution scale-down model validation and process characterisation to facilitate successful process validation and market supply. 3P delivers a profound knowledge of biologics manufacturing and its goal is to exceed clients’ expectations while providing tailored and effective solutions ensuring project success.