GMP manufacturing of biopharmaceuticals for clinical trials

Biotherapeutics – from your idea to a sterile IMP in a seamless process

Fraunhofer ITEM has more than 20 years’ experience in bioprocess development and early-stage GMP manufacturing of investigational biopharmaceuticals. A multidisciplinary team of biologists, chemists, pharmacists, engineers, and technicians will assist and lead you on your way from the idea for a new biotherapeutic via development of a production cell line to manufacturing of the investigational medicinal product (IMP) released for use in clinical trials. We will support your project with expertise accumulated from a broad range of biopharmaceutical candidates, from single proteins to complex structures such as viruses and cells, and will guide you along the regulatory pathway to your approved IMP dossier.

You provide us with a DNA sequence and our teams will guide you through all bioprocess stages from a production cell line to an aseptically filled IMP released for clinical trials.

Your benefits

© Photo Fraunhofer ITEM

Fraunhofer ITEM is embedded in a sustainable network of trusted partnerships, both internal and with external service providers approved by drug agencies to provide you professional access to state-of-the-art technologies.

For more than 20 years, Fraunhofer ITEM has maintained a sustainable relationship with regulatory agencies, providing our clients with best-fit solutions for their IMPs.

Fraunhofer ITEM offers seamless approaches by interfacing with the institute’s preclinical research and clinical trial departments.

Twenty years of experience means we have developed a broad range of different molecules and processes including proteins, glycoproteins, a large diversity of IgG antibodies, antibody fragments, bispecific antibodies, virus-like particles, bacteriophages, nucleic acids, and plasmids.

In 2015, a new filling line for glass vials and ampoules became operational, enabling Fraunhofer ITEM to fill the last gap remaining in the biopharmaceutical development chain from the first GMP batch of your investigational drug substance to the sterile IMP.

Roadmap for GMP manufacture of investigational biopharmaceuticals

Investigational medicinal products (IMPs) are manufactured in compliance with European drug regulations and with the quality requirements laid down in the Good Manufacturing Practice (GMP) guidelines of the European Union.

Whenever the drug substance, that is, the pharmacologically active component of an IMP, is a complex biomolecule (a protein, glycoprotein, or nucleic acid), GMP quality requirements have to be considered already when initiating development of the manufacturing process for the drug substance.

Bioprocess development and GMP manufacture are a sequence of steps that has to comply with distinct quality attributes.