Biologics

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DMPK Service

Drug metabolism and pharmacokinetics (DMPK) plays an important role in drug discovery. The DMPK properties of the product determine how much of the drug will reach its target and how long it will stay in the target area. DMPK is therefore closely related to the safety assessment. Pharmacologists are constantly adjusting DMPK during the discovery of biologic drugs to help select the best candidates to enter clinical trials. Inadequate ADME properties can decrease the bioactivity of a drug. Therefore, BOC Sciences is committed to selecting the most appropriate DMPK studies, including in vitro assays and animal models for evaluation. Our teams fully consider all aspects of how the compound of interest is metabolized in the human body including how the drug gets into the body, how it moves within the body, and how it get out of of the body. In addition to sufficient potency against the target protein and acceptable safety, the balance of optimized PK parameters and minimized drug-drug interaction potential helps to assess the safety and efficacy of the new biologics, maximizing the chances of the drug candidate becoming a successful therapy.

Application of DMPK Service

  • Safety assessment
  • Toxicology studies
  • Drug-drug Interaction studies

Bioanalytical  consideration for novel routes of administration. Figure 1. Bioanalytical consideration for novel routes of administration. (Mu, R.; Yuan, J. et al. 2022)

Our Services

To make it easier and better for researchers, BOC Sciences provides DMPK service service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. BOC Sciences' DMPK scientists and facilities can help our clients design optimal DMPK protocols to support diverse drug discovery and development needs and s their regulatory filings. Our in vitro and in vivo DMPK studies are applicable to the early medicinal chemistry and lead optimization phases of drug discovery.

  • We can provide ongoing assessment of dose-exposure-effect relationships in non-clinical and clinical studies
  • Our in vitro assays and in vivo prediction methods are available in estimating clinical interactions
  • BOC Sciences has introduced in silico DMPK approach to conduct virtual screening which provides the ability to optimize multiple properties simultaneously
  • We enable to perform in vitro assays and in vivo prediction methods for estimating clinical interactions

Structural  complexity of modalities and bioanalytical techniques. Figure 2. Structural complexity of modalities and bioanalytical techniques. (Mu, R.; Yuan, J. et al. 2022)

DMPK capabilities

  • Physicochemical assays
  • Solubility-kinetic and equilibrium
  • Chemical stability
  • Protein binding
  • In vitro drug metabolism assays
  • In vitro and in vivo Met ID and HRMS-radioprofiling
  • PK/PD
  • Human prediction
  • Formulation support
  • Metabolomics by NMR/LC-MS, including non-target and target metabolomics
  • Biomarkers

Why choose BOC Sciences?

Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:

  • Comprehensive, integrated CMC services with a flexible service model that grows with your programs
  • Knowledgeable industry experts who deliver scalable, actionable insights
  • World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
  • Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
  • A focus on risk management that is designed to ensure completion of your technical goals

BOC Sciences provides professional, rapid and high-quality services of DMPK at competitive prices for global customers. Personalized and customized services of DMPK can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!

Reference

  1. Mu, R.; Yuan, J. et al. Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics. BioDrugs. 2022. 36(2): 181-196.

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