Clinical Bioanalytical Analysis – Small Molecule

/Clinical Bioanalytical Analysis – Small Molecule
Clinical Bioanalytical Analysis – Small Molecule 2017-08-01T14:31:23+00:00

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Extensive Experience

MPI Research has developed and validated more than 800 proprietary bioanalytical methods over the past five years. The majority of these methods have been validated for the analysis of drugs in plasma, serum, or blood; however, methods have been validated for drug in urine, drug in tissue, and drug in lavage, swabs, or feces. All methods were validated in accordance with FDA and European Medicines Agency (EMA) guidelines for Bioanalytical Method Validation.

With a wealth of experience, MPI Research offers customized development and validation of a wide range of molecule types, including conventional small molecules, peptides, and oligonucleotides.

Unparalleled Timeliness

Co-located clinical and bioanalytical laboratories provides for unparalleled speed for first-to-file opportunities. We offer clinical summary reports in as few as 20 days from drug availability. For first-in-human trials, we can initiate analysis within hours of final blood collection and provide PK analysis within 48 hours.

Standard timeline for method development and validation is three weeks for small molecules. Our routine timeline for sample analysis is five-day turnaround of audited data.

Unique Service Offerings

For smaller molecular weights (<150 amu) or volatile compounds that lack the necessary sensitivity and selectivity by traditional LC-MS/MS, MPI Research offers GC-FID, GC-MS, or GC-MS/MS assays. Examples of methods developed include fatty acid methyl esters (DHA/EPA) or neurotransmitters.

Speed and Capacity

MPI Research offers comprehensive bioanalytical and pharmacokinetic services for Phase I first-in-human trials and bioequivalence studies, including expedited analysis for first-to-file opportunities. The key components of this success story are careful attention to workflow and process, along with high-throughput analysis using state-of-the-art automation and a proprietary electronic laboratory notebook (eLN).

Our standard timeline for method development and validation of a new chemical entity is four weeks for small molecules. Our routine timeline for sample analysis is five-day turnaround for 100% quality controlled data.

MPI Research is based in Mattawan, Michigan, and is dedicated to staying ahead of the technology curve with advanced instrumentation.

Current Resources

  • API 5000 MS/MS systems equipped high performance liquid chromatography (HPCL) and ultra-high performance (UHPLC) capabilities
  • Tomtec and PerkinElmer liquid handling systems for automation of sample preparation
  • Tissue sample preparation using Covaris AFA ultrasonic extraction instruments, equipped with cryogenic pulverization of hard tissues
  • Centralized Thermo Watson™ LIMS system for data management and reporting
  • Central security alarm monitoring system with 24-hour card-controlled facility access
  • On-site emergency power backup for all sample storage freezers (-20°C, -70°C)
  • Freezer temperature monitoring with remote notification capability
  • AC power failure monitoring systems with immediate notification capability
  • Incremental nightly data backups, full weekly and monthly backups
  • Backup generators and uninterruptible power supplies