Pharmaceutical Services

Xceleron can help you to design and implement preclinical and clinical fit-for-purpose investigations. Our clients use us to meet commercial objectives associated with:

  • Proof-of-concept
  • Asset sale
  • Asset purchase
  • Drug approval

Xceleron Pharmaceutical Services – Our approach


Xceleron employs a two-stage approach in using AMS. First we harness the selectivity, sensitivity and robustness of the AMS technology through analytical method transfer, method validation and sample handling – all captured in proprietary SOPs. Second, we work with our clients to design simple time- and cost-efficient preclinical and clinical protocols that get the best from AMS.

Study protocols are delivered using a network of long established and trusted development partners in Europe, America and Asia, supported as required by a dedicated Project Manager from Xceleron.

Our preclinical and clinical investigations can yield an extensive range of AMS-enabled outputs to support Proof-of-concept, Asset Sale, Asset Purchase and Drug Approval.

 

AMS analytical robustness and Sensitivity

AMS is analytically very specific, highly sensitive, free from biological matrix interferences and independent of test compound structure. These unique analytical characteristics result from the 14C microtracer and from the tightly controlled process used by Xceleron to turn the sample under investigation into the graphite that is ultimately loaded onto the AMS detector. The unique sensitivity of AMS enables very small samples to be analyzed – a few µL or mg and even down to a few thousand cells.

The process and instrument robustness is strengthened by Xceleron’s quality control procedures. Client samples can be analyzed as total 14C (all drug derived material) or fractionated using an appropriate separation technique (commonly HPLC) in order to measure specific analytes of interest. Quantitative and qualitative methods are designed for every investigation.

 

Improved R&D efficiency

Xceleron’s customers are using AMS to improve the efficiency of R&D through a combination of reduced development time and reduced expense

  • Analytical method development and validation is off the critical path
  • Intelligent preclinical and clinical designs are inherently shorter in duration and require less resource
  • Rich data set: all drug derived material, specific analyte and metabolite profiling measurement

Trusted partners that deliver

Xceleron has developed a tried and tested network of partners over time. This network is used to provide all of the components necessary to complete an AMS-enabled investigation

  • 14C labelling of the asset under investigation
  • Preclinical development to support clinical investigations
  • Clinical pharmacology units in Europe and N America to conduct volunteer studies
  • Clinical pharmacology and out-patient centers in Europe and N America to conduct patient studies
  • Matrix and tissue preparation centers
  • Complimentary LC-MS/MS analyses
  • Specialized PK analyses and report writing

 


 

Enriched Phase I Clinical Investigations

This is our most popular and fastest growing area of investigation. Xceleron has helped develop clinical protocols to support proof of concept investigations, asset sales, asset purchases and regulatory submissions. This approach is very cost- and time-effective because we leverage your Phase I investigations to gain additional endpoints. We do not require additional safety or dosimetry data over traditional Phase I clinical trials. As a result, we can generate valuable human disposition, bioavailability, or metabolism data within existing drug-development timelines and at incremental cost.

Xceleron’s enriched Phase I Studies inform Phase II-readiness as we:

  • Obtain human absolute bioavailability data
  • Gain vital PK data on high potency drugs in sensitive populations
  • Quantify drug distribution in target tissues such as biopsy samples, cerebral spinal fluid or skin blisters
  • Gain a first view of human metabolites for safety assessments

Xceleron has used AMS to deliver early insight to human metabolite exposure. We incorporate a 14C microtracer into an existing Phase I SAD, MAD, or Food Effect study. We combine the clinical plasma samples to form a single representative pool across all subjects / time-points and analyze this pool to give a single metabolite profile. From this we can establish the presence of human specific, significant and /or disproportionate metabolites.

 


 

Phase II and Phase III Clinical Investigations

Xceleron provides essential absolute bioavailability and mass balance data for late-stage studies. Our data support regulatory submissions to the EMEA and FDA and have contributed to numerous filing packages for marketed drugs. In 2013 six out of 27 new drugs approved by FDA were supported by AMS data.

We have established specialized validation packages to support the bioanalytical requirements of late-stage studies, an important consideration when the study is being used for regulatory submission.

 


 

Phase 0 Microdosing Clinical Investigations

For Confident Decision Making in Early Drug Development

Drug-development teams turn to us for Phase 0 microdosing studies when they need to select the most promising compounds for full drug development or to confirm that their compound reached its target site of action.

In microdosing studies, the dose administered is very small, 1/100th of the predicted pharmacologic dose to a maximum of 100 µg. At Xceleron, we are able to detect those minute drug traces in the blood, tissue, and body fluids using AMS analysis.

Because these small doses are inherently safer than pharmacologically active doses, regulatory authorities accept a much reduced safety toxicology package. Consequently, Phase 0 clinical trials can allow drug developers to obtain human data earlier and with less expense compared to a Phase I clinical study.


Client case study links

Proof-of-concept »  Asset sale »  Asset purchase »  Drug approval »


Client case study PDF

Xceleron Webinar 2015-03-26 Q&A

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