With its expertise, Pentracor GmbH covers the entire life cycle of a therapeutic adsorber. We are happy to provide you with this experience. Whether you have a feasibility project, want a complete adsorber development, are looking for a contract manufacturer for adsorbers or need support in quality management – with us you are right. Below you will find a list of our services offered. We are happy to provide you with a suitable offer.

Feasibility studies

Feasibility studies are smaller projects for the proof of concept. Our range of services includes:

  • Development of detection systems
  • Coupling of ligands to matrices on a mini scale (1 ml columns)
  • Review of target molecule binding
  • Examination of specificity
  • Check of sterilization
  • Documentation

Development

We develop a customer-specific adsorber for you. The work programmes will be adapted according to the planned application (therapeutic adsorbers, adsorbers for research purposes, adsorbers for industry). We offer for you:

  • Development of detection systems
  • Coupling of ligands to matrices on a mini scale (1 ml columns)
  • Optimization of coupling taking into account production requirements
  • Characterization of the coupled matrix (binding properties, capacity, specificity …)
  • Development of a sterilization protocol
  • Development of quality controls
  • Scale-up
  • Supervision of biocompatibility examinations
  • Compatibility investigations
  • Stability studies
  • Documentation

Contract production of adsorbers

We manufacture therapeutic adsorbers for you in our cleanroom. Depending on your needs, we can do the following work:

  • Optimization of coupling taking into account production requirements (laboratory scale)
  • Scale-up
  • Implementation of production in cleanroom
  • Validation of the sterilization protocol
  • Validation of quality controls
  • Validation of production
  • Pilot productions
  • Production of adsorbers for clinical trials
  • Documentation

Quality management according to ISO 13485 (EU) and FDA standards

We offer advice and support on the way to CE certification and FDA approval. We can offer you the following services:

  • Risk management
  • Building a QM system
  • Create a technical documentation
  • European Representative for Therapeutic Adsorbers

Sales

We provide you with support for successful market entry through:

  • Transfer to our own sales network
  • Medical Device Consultant for Germany
  • Mediation of sales partners abroad