GMP manufacturing of biopharmaceuticals for clinical trials

Developing your idea into a sterile IMP in a seamless process

Fraunhofer ITEM has more than 25 years of experience in bioprocess development and in GMP manufacturing of biopharmaceutical active ingredients (APIs) and investigational medicinal products (IMPs) for clinical trials. A multidisciplinary team of biologists, chemists, pharmacists, engineers, and technicians assists and leads you on your way from the idea for a new biotherapeutic via the development of a production cell line to the manufacturing and release of an IMP. Depending on your requirements, our services can cover either the complete process or only individual phases.

  • As a Fraunhofer ITEM client, you will benefit from competences and expertise accumulated over years in a broad range of projects on biotherapeutics – from recombinant proteins and glycoproteins to complex multimolecular structures such as viruses and cells.
  • We provide you with the API and IMP and will guide you through the regulatory requirements to an approved IMP dossier for your drug candidate.
  • We aid you on your way from the idea for a new biotherapeutic via development of a production cell line to GMP manufacturing of the IMP released for use in clinical trials.

Our services and expertise

Please contact us in order to come up with a joint solution for how we can meet your individual needs

Development of mammalian and microbial production cell lines

 

GMP manufacture of master and working cell banks

Development of robust upstream and downstream sequences with subsequent upscaling

 

GMP manufacturing of investigational APIs

 

Quality control testing of biopharmaceutical APIs and IMPs

 

Aseptic filling and release of liquid dosage forms of IMPs

Your benefits

© Fraunhofer ITEM, Ralf Mohr

Fraunhofer ITEM is embedded in a sustainable network of trusted partnerships, both internal and with external agency-approved service providers. Fraunhofer ITEM stands for professional access to state-of-the-art technologies that you need for your candidate biotherapeutics.

Fraunhofer ITEM is in close contact with the regulatory agencies from the very beginning of your project. We assist you in consulting and scientific advice meetings with the competent authorities such as Paul-Ehrlich-Institute (PEI) and the German Federal Institute for Drugs and Medical Devices (BfArM).

Preclinical development as well as clinical trials can be performed in other Fraunhofer ITEM departments, which are embedded in the same quality network. We can offer streamlined and sustainable project approaches.

A clean-room facility for aseptic fill and finish of vials and ampoules has been operational since 2015, enabling production of ready-to-use sterile IMPs and other small batches of up to 3000 dosage forms.

Roadmap for GMP manufacturing of investigational biopharmaceuticals

© Fraunhofer ITEM
Roadmap for GMP manufacturing 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.

Biopharmaceutical consultancy

  • Selection of mammalian or microbial expression systems suitable for production of the desired molecule
  • Outline of appropriate cloning strategies
  • Assurance of technical and regulatory requirements for the production cell line/cell substrate
  • Scheme for master, working, and post production cell bank characterization
  • Evaluation and qualification of analytical service laboratories for cell bank and drug substance/drug product characterization
  • Development of cultivation and purification strategies
  • Identification and assessment of critical product and process attributes
  • ICH-associated/-compliant stability studies for biopharmaceutical drug substances and investigational medicinal products (IMP)
  • Design of protocols for transfer of processes and analytical procedures from and/or to third parties (CMOs, contract laboratories)
  • Due diligences of CMOs and contract laboratories
  • Strategy development, document preparation, and client support in preparation of and during scientific meetings/scientific advice with regulatory agencies
  • Preparation of CMC sections of IMPDs/medical writing

Your contact for biopharmaceutical issues

Many years of experience are an asset which our Division of Pharmaceutical Biotechnology uses for consultancy services on a wide variety of biopharmaceutical drug candidates over their entire development life cycle, from the initial idea to first-in-man trials.

Holger Ziehr

Contact Press / Media

Prof. Dr. Holger Ziehr

Division Director of Pharmaceutical Biotechnology

Phone +49 531 6181-6000