Operations

Sobi provides and develops specialty and niche pharmaceuticals for rare diseases.

Our portfolio includes proprietary products, focused on haemophilia, inflammation and genetic ­and metabolic diseases, and approximately 30 products from 20 partners. We also contract manufacture the drug substance for Pfizer’s recombinant haemophilia treatment, ReFacto AF.

Partnering is a core value driver for the company. 

An integrated biopharmaceutical company

Operations include capabilities from pre-clinical development, process development and manufacturing of protein pharmaceuticals to market access and commercialisation.

Integrated company illustration of Sobi's operations

True availability and access to treatment for patients is what brings long-term value to the patients we serve, our employees, partners and share­holders. The capabilities that make this possible are our knowledge of bio­logics manu­facturing and industrialisation, our in-house research and development com­petencies within protein characterisation, and our ability to ­provide access to treatments for rare disease patients. We believe that our ability to ­partner and to pioneer with different stakeholders and bring together all the opportunities that exist to facilitate effective and timely rare ­disease therapy development creates unique opportunities to add value to the rare ­disease field.

Focused R&D

The expertise in research and development is mainly focused on late preclinical and clinical development of biologics, as well as on protein manufacturing and process scale-up. 

Experienced regulatory affairs

Sobi has the capacity internally to handle the full range of regulatory submissions, such as Orphan Drug Designations, Clinical Trial Applications, requests for Scientific Advice, Paediatric Investigation Plans and Marketing Authorisation Applications. 

World-class manufacturing

The close collaboration and integration within our project teams, and with our biologics manufacturing unit in Stockholm, Sweden, is a key success factor for both the development of candidate drugs and our other programmes. 

Our in-house competences provides an understanding of the elements needed in order to successfully scale up and prepare for commercial-scale production. A holistic view of the process, with integrated development and manufacturing approaches, supports our ability to reduce the overall time from early development to products reaching the patients, without compromising safety.

Strong marketing & sales organisation

With our head office in Stockholm, Sweden, the organisation now spans 24 countries, delivering treatments to patients in over 60 countries across the globe. Europe is the core market for our haemophilia franchise. 

 

 

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