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PharmaPrimes Laboratories

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Bioanalytical Services

Supporting Drug Development from Discovery to Clinical Studies

Introduction

Regulatory-Focused Bioanalysis

PharmaPrimes provides advanced bioanalytical services supporting pharmaceutical and biopharmaceutical development programs.

Our laboratories provide regulatory-focused bioanalysis for small molecules, peptides, monoclonal antibodies, therapeutic proteins, and other biologics.

Our integrated services support preclinical studies, clinical trials, bioequivalence studies, and biosimilar development programs.

Capabilities

Bioanalytical Capabilities

Small Molecule & Peptide Bioanalysis

  • PK Analysis
  • Metabolite Identification and Quantification
  • Bioequivalence and Bioavailability Studies
  • Therapeutic Drug Monitoring Support
  • Preclinical Sample Analysis
  • Clinical Sample Analysis

Large Molecule & Biologics Bioanalysis

  • Monoclonal Antibodies
  • Therapeutic Proteins
  • Biosimilars

Supporting:

  • Pharmacokinetic Studies
  • Biosimilar Comparability Programs
  • Immunogenicity Evaluation
  • Biomarker and Binding Assays

Immunogenicity Assessment

  • Anti-Drug Antibody (ADA) Assays
  • Neutralizing Antibody (NAb) Assays
  • Cut-Point Determination
  • Statistical Analysis
Method Development

Customized Methods for Challenging Molecules

Customized bioanalytical method development for challenging drug molecules and complex biological matrices.

PharmaPrimes has documented experience with challenging metabolic drugs and GLP-1 analogues, including:

SemaglutideLiraglutideTirzepatide
Method Validation

Validated to ICH M10

Bioanalytical methods are validated according to applicable ICH M10 Bioanalytical Method Validation requirements.

Preclinical & Clinical Bioanalysis

  • Preclinical Studies
  • Clinical Trials Phase I–IV
  • Bioequivalence and Bioavailability Studies
Analytical Platforms & Technology

Bioanalytical Infrastructure

LC-MS/MSBio-inert chromatography systemsELISA platformsqPCR systemsWatson LIMS
Related Services

Explore Related Capabilities

Bioequivalence & Bioavailability

Integrated clinical and bioanalytical support for BE/BA studies and pharmacokinetic evaluation.

Biosimilar Services

Analytical characterization, purity and heterogeneity assessment, glycosylation profiling, biological activity, process-related impurity testing, clinical PK, and immunogenicity support.

Clinical Research

Hospital-based clinical research through the PharmaPrimes Clinical Research Center located within Jordan Hospital in Amman.

Discuss Your Bioanalytical Program

Tell us about your molecule, matrix, and study design, and our bioanalytical scientists will propose a method development and validation approach.

Request a Quotation