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.
Our bioanalytical laboratory in Amman, Jordan holds a Jordan Food & Drug Administration (JFDA) Bioanalytical Laboratory Authorization and JFDA GCLP and GLP compliance certificates. Bioanalytical work is led by Dr. Abdulnaser Alsharaa, our Bioanalysis Department Head.
Bioanalytical testing is the measurement of drugs, their metabolites, and biological molecules in biological matrices such as plasma, serum, blood, and urine. These results are used to build pharmacokinetic (PK) profiles, compare formulations in bioequivalence studies, assess immunogenicity, and support regulatory submissions.
Because regulators rely on these concentration data, each bioanalytical method must be validated before study samples are analyzed. At PharmaPrimes, this validation follows ICH M10.
For bioequivalence and bioavailability studies, bioanalysis runs together with clinical conduct at the PharmaPrimes Clinical Research Center at Jordan Hospital in Amman. See Bioequivalence & Bioavailability Studies.
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:
Bioanalytical methods are validated according to applicable ICH M10 Bioanalytical Method Validation requirements.
Before study samples are analyzed, each method is validated for parameters such as selectivity, accuracy, precision, and stability. Read our ICH M10 bioanalytical method validation guide.
Dr. Abdulnaser Alsharaa, Bioanalysis Department Head, holds a PhD in Bioanalytical Chemistry (KFUPM) and two US patents. His European industry experience includes Eurofins Netherlands, TNO, Charles River Laboratories, and Ardena Belgium, with expertise in LC-MS/MS, GC-MS/MS, and ICP-MS.
It is the measurement of drugs, metabolites, and biological molecules in matrices such as plasma, serum, blood, and urine, used for pharmacokinetic, bioequivalence, immunogenicity, and biosimilar studies.
LC-MS/MS quantitative bioanalysis, ELISA-based ligand binding assays, ADA and NAb immunogenicity assays, and qPCR assays.
Yes. Bioanalytical methods are validated according to applicable ICH M10 Bioanalytical Method Validation requirements.
Yes. PharmaPrimes has documented experience with semaglutide, liraglutide, and tirzepatide, and develops customized bioanalytical methods for challenging peptides.
Yes. The laboratory holds a JFDA Bioanalytical Laboratory Authorization and JFDA GCLP and GLP compliance certificates.
Yes. Bioanalysis is integrated with clinical conduct at the PharmaPrimes Clinical Research Center at Jordan Hospital in Amman.
Integrated clinical and bioanalytical support for BE/BA studies and pharmacokinetic evaluation.
Analytical characterization, purity and heterogeneity assessment, glycosylation profiling, biological activity, process-related impurity testing, clinical PK, and immunogenicity support.
Hospital-based clinical research through the PharmaPrimes Clinical Research Center located within Jordan Hospital in Amman.
Tell us about your molecule, matrix, and study design, and our bioanalytical scientists will propose a method development and validation approach.
