Quantification in Complex Matrices


Quantification: Assay development, validation of substances in plasma / urine / tissue escorting clinical phases I-III (bioavailability as well as bioequivalence), preclinical phase and early stage investigation.

We quantify drugs, narcotics, metabolites and endogenous substances in virtually any  biological matrix. Based on decades of experience and state of the art equipment we develop methods with extremely high sensitivity (down to femtogram/mL in plasma) and maximal selectivity. We have remarkable expertise analyzing inhalative drugs.

Since 2003, acquired and generated data is being stored in an industry-standard, fully certified and validated electronic archive that meets European Commission and FDA (21 CFR Part 11) requirements.

Sample quantities range from high throughput (thousands of samples) down to studies with just a few samples.

Our sponsors are Medium and Big Pharma as well as biotechs.
 

  • Small Molecules
  • Peptides
  • Complex Drug Delivery
  • Quantification in Formulation

  • Quantification of Small Molecules in biological matrices predominantly with HPLC-MS/MS

    Extremely Sensitive and Selective Assays (down to 250 fg/mL in plasma)

    Minimal Sample Volumes:
    Due to high sensitivity, down to 0,05 mL human plasma if necessary (benefit in context pediatric sampling!)

    Example PK at extremely low concentration level:


    Publications:
    We have published over 100 papers related to Small Molecules in peer reviewed journals (see R&D / Publications). 

  • HPLC-MS/MS is the first choice quantifying peptides due to its high sensitivity and selectivity at reasonable efforts. Mass spec assays do not require antibodies, this fact saves a lot of cost and especially time.

    pharm-analyt has more than a decade of experience in analyzing peptides (up to 15kDa) in plasma with HPLC-MS/MS.

    Sensitivity:
    Dependent on sequence and size, pharm-analyt is able to quantify peptides in plasma down to the range of pg/mL (for smaller peptides).

    Stability:
    Stability of peptides in biological matrices is always an issue (sometimes very short half life). Based on our experience, pharm-analyt has noticeable skills stabilizing peptides in plasma, an important pre-requisite for correct results.

    Selectivity:
    The challenge of isolating and analyzing peptides selectively in plasma is huge, considering the innumerous "enemies".
    The chart below outlines the dimensions of the enormous abundance of analytical rivals of peptides.

    Concentration of selective substances in plasma (attention: concentration to intervals of 10).
    Source: "HPLC Methods for Clinical Pharmaceutical Analysis", Hermann Mascher, WILEY-VCH

    Publications:
    We have published several papers related to peptides in peer reviewed journals (see R&D / Publications). 

  • "Controlled Delivery"continues being a strongly emerging field. In recent years pharm-analyt has continually been confronted with analytical tasks related to the field of special drug delivery, not limited to slow release formulations.

    PEGs
    Meanwhile our team has vast experience quantifying PEGylated APIs of any kind (PEGs between 1-100 kDa in plasma).
    Often it comes down to determination of total drug (e.g. liposomes) vs. free drug (e.g. oncological or toxic drugs).


    Quantifying Other Complex Substances:
    Polysaccharides
    Oligonucleotides
    Sulfated Polysaccharides
    etc.

  • Quantification in dose solutions and various galenic forms

    Filteranalysis

    GMP Certified