Life science companies deals regularly with temperature sensitive materials and samples such as:

Biological samples

  • Pre-clinical toxicology specimen samples
  • Biobank from clinical studies
  • Recombinant produced proteins
  • Cell and tissue samples
  • Temperature-sensitive synthetic peptides
  • Buffers
Pharmaceutical materials

  • Pharmaceutical substances for pre-clinical trials
  • Pharmaceutical drugs for clinical trials and sales
  • API for toxicology research, in vitro pharmacology
  • API for formulation research
  • API for GMP production
  • Reference substances

 

Common to all these samples and materials are that they represent a unique asset to the company that needs to be stored at safe, compliant and at appropriate temperature conditions in order to not erode high values for the company.ClinStorage has a growing customer base that keeps the plasma and tissue samples from clinical studies.

In pace with the increasing complexity of clinical research also increases the requirements for being able to save samples in a quality safe place. To retrospectively analyze samples for particular biomarkers and ”responders / non-responders” will increase the probabilities of success with drug project. When unexpected events (side effects) can a stored sample be crucial to find a causal connection. Even at a licensing process can saved samples increase the value of the project in which the licensee may be able to verify previous analytical results or to conduct new analyzes such as biomarkers.

The Swedish Act ’Biobanks in Medical Care Act‘ (SFS 2002:297) allows that human biological specimens that have been collected and/or stored within healthcare can be used for research and clinical trials if the patients/donor have given consent to this. The Biobank Act requires full traceability of all collected samples, which means that barcode labeling and registration in digital lab data systems are recommended.

When the sample is sent for analysis or storage to another organizer, a Material Transfer Agreement (MTA) shall be established with the host laboratory/storage facility.ClinStorage can support you in all necessary actions that need to be taken regarding approvals for human sample collection and long term storage.ClinStorage is your storage facility for Drug Substance/Drug Product while waiting for pre-clinical/clinical studies to start and/or as a hub for further distribution to clinical sites.

Of outmost importance is to have your Reference and Retention Samples stored in a safe and secure place separated from the laboratory/production facility. ClinStorage is highly suitable for this purpose.