BioAgilytix understands that when it comes to pharmacokinetic (PK) assays, it is of highest priority that the applied bioanalytical method is well characterized, fully validated, and documented in order to yield reliable results. We offer high-quality PK assay procedures and results strictly in compliance with GLP / GMP regulations and in accordance with international regulatory standards (FDA, EMEA, ICH).
Find Answers to Your PK Questions:
What are your specific assay needs? Let’s schedule a conversation to review your questions and requirements with one of our scientists.
Pharmacokinetics (PK) describes what the human body does to a given pharmaceutical, from the time of administration to absorption, distribution, metabolism, and excretion from the body. By assessing PK of a biological drug in different matrices, including serum, plasma, urine, and saliva, we can understand a drug’s interaction with the body, as well as the intensity and duration of its efficacy.
Understanding the pharmacokinetic behavior of a given therapeutic drug is an essential element of understanding its effectiveness and safety, as well as identifying the proper dosage and distribution. As such, PK assays are a vital component of the drug development process, and the data derived is used to help select dosage for preclinical and clinical studies. The Federal Drug Administration (FDA) has also issued extensive industry guidance on measuring Population Pharmacokinetics (PK).
2014 Marini, Gouty et al. paper
See recommendations from the AAPS Biosimilars Action Program Committee (APC) for the development and validation of LBAs to support PK assessments for biosimilar drug development.
Our scientists are experienced in supporting PK assessments in a variety of species including rodents, humans, and non-human primates, and in multiple matrices such as serum, plasma, urine, and saliva. We are well-versed in the factors that could influence the validity of the data generated by these assays, and take those complexities into account during method validation to ensure optimal results. Our team has a clear understanding of the ability of the assay to detect the drug in the sample matrix.
In addition to their use for the detection of monoclonal antibodies using anti-idiotypic antibodies, BioAgilytix establishes and validates PK assays for therapeutic proteins with endogenous counterparts. PK assays are also required for comparative analysis of originator and biosimilar products, which our team is well-versed in performing.
We conduct our high-quality PK assay procedures and results strictly in compliance with GLP / GMP regulations and in accordance with international regulatory standards (FDA, EMEA, ICH).
There are several analytical technologies that can be used for PK analysis. BioAgilytix will help you select the best-fit platform for your project, based on both sensitivity and regulatory requirements. We have extensive experience developing and validating assays to evaluate pharmacokinetic behavior throughout the phases of the drug development process using the platforms listed below.
ELISA
MSD-ECL
Gyrolab xP
ProteinSimple
Download the white paper “Serum pharmacokinetics and cerebrospinal fluid concentration analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study”, contributed to by our Global Chief Scientific Officer, Dr. Arno Kromminga.
BioAgilytix combines a diverse range of platform offerings with a team of tenured scientists who are expert in the complexities of PK analysis. The result is scientific excellence, delivered on a global scale to customers at any phase of the drug development process. We have proven our expert ability to interpret this assay data to gain an accurate understanding of the absorption, distribution, metabolism, and excretion characteristics of the product. We also offer these services under GLP, GMP, and GCP to meet your regulatory requirements.
Our PK Expertise Includes:
Let our specialized scientists help you identify the optimal method and platform for your pharmacokinetic assay needs today.
Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves.
Mitra Azadeh, Boris Gorovits, John Kamerud, Stephen MacMannis, Afshin Safavi, Jeffrey Sailstad, Perceval Sondag. AAPS J 2018 Jan; 20:22- Open Access White Paper.
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Serum pharmacokinetics and cerebrospinal fluid concentration analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study.
Curtin F, Vidal V, Bernard C, Kromminga A, Lang AB, Porchet H. MAbs. 2016 Jul;8(5):854-60.
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eBook: Bioanalysis for Biosimilars Development
D. Gouty, 2015. Bioanalysis Zone.
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Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein.
Curtin F, Perron H, Kromminga A, Porchet H, Lang AB. MAbs. 2015;7(1):265-75.
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Recommendations on incurred sample stability (ISS) by GCC.
Lowes S, Gouty D, et al. Bioanalysis. 2014 Sep;6(18):2385-90. doi: 10.4155/bio.14.155.
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Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.
Marini JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR. AAPS J. 2014 Nov; 16(6):1149-58. doi: 10.1208/s12248-014-9669-5. Epub 2014 Oct 3.
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See how our immunogenicity expertise complements our PK services by measuring adverse immune reactions for many drug- and disease-specific aspects.
Learn how we will translate our experience working with over 500 biomarkers in singleplex and multiplex formats to your project’s success.
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