About Us

Our Story

Extractus was born from the idea that we can do better.  Our team have collectively used many different CRO services in the process of drug, medical device, and consumer health product development, so we have an intimate understanding of the customer perspective.  In our experience, a typical CRO does not always understand why a study is important or how to communicate with customers in a timely and meaningful way.  Our aim is to be better than the competition by providing the best science possible at reasonable prices, and supporting our customers with sound advice and good communication. 

Our core team has worked on biopharma single use systems, ophthalmic, parenteral, topical, transdermal, oral, suppository and orally inhaled or nasal drug products.  We have contributed to regulatory submissions, defended agency questions and audits, and put in place mitigation strategies where needed.  We have worked for big pharmaceutical companies, start ups and everything in between, so we understand what is needed and how to make things work on a budget. 

Our laboratory is modern, and built with compliance and data integrity from the ground up.  We are proudly running Agilent mass spectrometry instrumentation, as well as equipment from trusted suppliers such as Mettler-Toledo and Eppendorf.  We employ robotics from CTC to perform sample preparation, and use statistical analysis and software automation to extract data with automated workflows to generate high quality data from your samples. These systems improve reproducibility and productivity, and we pass those savings on to our customers.  

Why we're different

We are a small CRO that specialises in Extractables and Leachables, so we are experts in performing E&L studies that meet or exceed regulatory expectations.  Here are some of the ways we are superior to the competition.

  •  Duplicate extraction of sample. Few (if any) CROs offer duplicate extraction, but it is important to have replicates to ensure the data is reproducible.  Extractus performs duplicate extractions as standard and triplicate extraction upon request.
  • Injection of E&L standards.  Most CROs will only inject a few standards with their analysis and they are not always reflective of the extracted material.  Extractus will include a wide selection of reference materials and standards for each analysis based on your material, to ensure accurate quantitation and identification of unknowns.
  • Multipoint Calibration.  Many CROs use single point calibration to estimate concentration.  Extractus always uses a minimum of a five point calibration for each standard.  We also include bracketed standards and blanks to adhere to ICH guidance.
  • Solvent and Extraction Blanks.  Not all CROs use both extraction and solvent blanks, but we include them as standard.  Solvents have extractables that can confound the data.  We test raw solvent as well as solvent that has been extracted in the sample glassware to avoid false positives.
  • Automation. Robotics has been available for many years but implementation within the E&L space is not widespread.  Using automation to perform repetitive tasks reduces error and increases productivity. This results in a quicker service and improved reproducibility, allowing Extractus to offer a service that is more cost effective for the customer. 
  • Statistical Analysis. As most CROs only make single extraction and injection, they can’t apply statistical analysis.  Extractus utilises duplicate extraction and triplicate injection of each extraction; we apply statistical analysis to ensure that each compound detected is accurately quantified, and eliminate any false positives from the results.