Bioanalytical Solutions for Pharma

At ABF, we specialize in the precise quantification of drugs, narcotics, metabolites, and endogenous compounds in various biological matrices. Our dedicated bioanalytical department comprises an experienced team of scientists and technicians with decades of experience in bioanalysis. Our state-of-the-art laboratory is equipped with six triple quadrupole LC-MS/MS instruments, ensuring high sample throughput, sensitivity, and selectivity. Our comprehensive services include: • Analytical method development and validation, including proprietary methods • Method transfer, optimization, and cross-validation of sponsor-supplied methods • Non-proprietary assays to support bioequivalence, drug-drug interaction, and various other types of studies • Quantitative sample analysis in human and animal matrices, such as blood, plasma, serum, urine, saliva, feces, and tissues from diverse species • Bioanalytical reports compliant with GLP/GCP standards for regulatory submissions • Long-term stability testing in matrices. • Long-term storage capacity for over 100,000 samples.

Understanding the fundamentels of pharmacokinetics (PK), pharmacodynamics (PD), and toxicokinetics (TK) is of utmost importance in drug development. At ABF, we boast a wealth of experience in this field, offering ultra-sensitive, cost-efficient, and high-throughput analytical methods adhering to ICH M10 guidelines and GLP/GCP principles. For instance, one of our validated, ultrasensitive LC-MS/MS method has been used to support several regulatory submissions to the US Food and Drug Administration (FDA) , establishing ABF as a trusted partner for your PK, PD and TK analysis.

ABF is a reliable partner to support your drug development program. We offer full services in chemical structure elucidation, metabolite profiling, impurity identification, and degradation product analysis. As regulatory demands for product knowledge continue to rise, our experienced team is well-positioned to meet your requirements. Our expertise is rooted in extensive, year-long experience with high-resolution mass spectrometry (LC-Orbitrap-MS), allowing us to successfully identify human metabolism for a variety of chemicals. From in vitro metabolite identification to human ADME studies, our highly experienced scientists offer direct support. We partner closely with our clients to provide valuable insight, detailed explanations, and cost-effective solutions.

Unlock valuable insights into drug safety and efficacy with biomarkers. ABF provides a diverse range of innovative technology platforms to help you select the perfect solutions for your requirements. With more than forty years of experience in biomarker research, we have accumulated a wealth of knowledge in the analysis of various matrices, including serum, plasma, urine, saliva, sputum and tissue. Our research has been published in peer-reviewed journals, demonstrating our dedication to enhancing the field. We comply with all international regulatory guidelines to guarantee exceptional standards in biomarker analysis.