Recipharm Biologics is part of Recipharm AB of Sweden, one of Europe’s leading contract development and manufacturing organizations. Privately owned and financially robust, Recipharm specializes in providing customers with a full-service, one-stop-shop approach — from formulation and analytical development through to commercial manufacturing. We employ some 1,400 people and have been operating since 1995. With manufacturing facilities located in Sweden, France, the United Kingdom, and Switzerland, we can handle a wide range of dosage forms including solid dose, sterile (liquids and freeze dried), semisolids, beta lactams, hormones, dry powder inhalers, granulates, and powders. This is complemented by a dedicated development center where our scientists can formulate, develop analytical methods, and manufacture clinical trial materials into most dose forms from just an active pharmaceutical ingredient (API).

Development and Supply of Recombinant Proteins and Monoclonal Antibodies

Recipharm Biologics is located close to Stockholm and was acquired from AstraZeneca at the beginning of 2009. The pilot facility is designed for the development and supply of recombinant proteins and monoclonal antibodies from mammalian cells. With both fed-batch and continuous perfusion, batch sizes up to 250 L are possible. There are plans to install a new disposable bioreactor suite increasing this to 1,000 L. This is complemented by comprehensive analytical expertise including advanced mass spectrometry for protein characterization and comparability studies.

By working closely with customers, we design a development program to ensure that strategic targets are met at the quality required by regulatory agencies. Our team of scientists is equally familiar with the production of monoclonal antibodies in fed-batch as they are in the production of recombinant proteins using perfusion technology. Our expertise and state-of-the-art equipment allow us to design processes that are appropriate to your development phase.

Fill–Finish and Lyophilization Services

Sterile liquids and freeze-dried powders can be formulated and filled into a variety of containers including vials ranging 2–100 mL in size. We can develop and optimize lyophilization cycles and run stability studies in compliance with ICH guidelines.

Adding Value By Focusing on Your Needs

We add value to customer projects by ensuring that their processes are designed and optimized to expedite commercial development. We can support process transfers both in and out and manage biosafety testing for cell banks and virus removal studies including documentation to support file submission to the EMEA and the FDA.

A Complete Service from DNA to Vial

• Production cell line development

• Upstream and downstream process development

• Analytical method development and validation

• Material supply for preclinical and toxicological studies

• Clinical grade material supply according to cGMP

• Stability studies

• Analytical services including product characterization

• Cell bank storage

• Formulation of sterile liquids or freeze-dried powders