LC-MS/MS Based Bioanalytical Expertise

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lliance Pharma’s bioanalytical team has extensive experience developing and validating robust LC-MS/MS methods for hundreds of compounds in various biological matrices (e.g. plasma, blood, urine, cerebrospinal fluid, and tissues) to support all phases of pre-clinical and clinical drug development. Our expertise spans a variety of compound types including conventional small molecules, peptides, large proteins and antibodies, antibody-drug conjugates, oligonucleotides, and trace metals. Our ability to consistently deliver timely and dependable results has earned us an excellent reputation dealing with unique and challenging bioanalytical methods and assays.


Bioanalytical Services

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The bioanalytical team offers method development, method validation and sample analysis using state-of-the-art liquid chromatography and mass spectrometry (LC-MS/MS)and ICP-MS platforms. We conduct method validation and sample analysis in compliance with regulatory guidelines to support all stages of pharmaceutical development. Methods are developed and validated in accordance with either client-specific protocols or internal SOPs, and all methods are validated to meet appropriate and relevant regulatory guidelines. We are capable of handling both controlled substances (schedule 1 to 5) and radioactive materials, and have a large sample storage facility to serve as your central laboratory.

Our current offerings include:

Discovery SupportLARGE MOLECULE BIOANALYSIS

  • Rapid method development of fit-for-purpose methods
  • Customized method qualification
  • High throughput analysis to support discovery TK/PK/PD studies and in vitro assays
  • Homogenization and analysis of tissues to assess drug distribution
  • Biomarker analysis for pre-clinical pharmacology studies


IND Enabling and Clinical Support

  • Method development
  • Method transfer and optimization
  • Full method validation per FDA/EMA/MHRA/ICH guidance
  • Cross-validations with partner laboratories
  • GLP sample analysis to support pre-clinical TK/PK studies
  • GCP standard sample analysis to support all phases of clinical trials
  • Clinical sample analysis to support bioequivalence studies
  • CLIA and COLA standard diagnostic biomarker analysis
  • Bioanalysis of samples with radio-labeled compounds

 

Technology Platforms & Techniques

  • UHPLC-UV/Visible and Fluorescence detection
    • Shimadzu LC-20 & LC-30
    • Agilent 1290 Infinity II
    • Agilent Bio-Inert UHPLC
    • Dionex nanoRSCL 2D
  • LC-MS and LC-MS/MS
    • Sciex API 4000, 4000 QTrap, 5500, and 6500 Triple Quads
    • Agilent 6495 Triple Quads
  • High ResolutionAccurate Mass MS
    • Thermos Scientific Q Exactive
    • Thermo Orbitrap XL
    • Agilent 6545XT Q-TOF
  • ICP-MS
    • Agilent 8900 Triple Quads
  • Specialized sample preparation techniques
    • Derivatization, SPE, LLE
    • Immuno-affinity enrichment
    • Hybrid LBA-LC/MS
    • Enzymatic digest with surrogate peptide analysis for large molecules
    • Intact protein analysis and characterization

 

We are capable of handling controlled substances (schedule 1 to 5), highly potent pharmaceutical compounds (OCH category 3 – 5), and radioactive materials. Additionally, we have a large sample storage facility to serve as your central laboratory.

Review some examples of assays we’ve developed and/or validated here.

Seeking approval for your drug or device in China? Ask us about our partnerships that can facilitate transfer of your methods to our partner lab abroad.

 

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