MicroConstants is now BioAgilytix San Diego

July 22-25, 2024 

Intercontinental  |  Kansas City at the Plaza  |  Kansas City, MO 64112 

Booth #8

Booth #8

For more than 25 years BioAgilytix San Diego, formerly MicroConstants, has been serving the growing biotechnology community on the west coast. Our lab is one of the world's leading bioanalytical contract labs, specializing in research services to support you throughout all stages of the drug development process. We focus on personalized service where you receive expert consultation through one point of contact during your entire project.

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San Diego Lab Expertise

Bioanalytical Strategies for Immunogenicity Assessment of ASOs

Presenter: Andrea Sequeira | Scientist I

Tuesday, July 23, 2024

12:00 – 12:30 PM

Location: Salon II

Implications of Draft FDA Guidance on Potency Assays for G&CT

Speaker: Manoj Baskaran | Scientist III

Tuesday, July 23, 2024

4:00 - 4:15 PM

Location: Salon III

Transfer and Validation of Flow Cytometry Assay Across Platforms and Labs

Speaker: Manoj Baskaran | Scientist III

Wednesday, July 24, 2024

3:45 -4:00 PM

Location: Salon III

Validation Best Practices: PCR Case Studies in Shedding

Speaker: Bryan Gullick, Ph.D. | Director

Wednesday, July 24, 2024

2:35 – 3:05 PM

Location: Salon II

San Diego Lab Expertise

Small Molecule Bioanalysis

Specializing in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, macromolecules, proteins, peptides, and metabolites using regulated and non-regulated LC/MS/MS, HPLC/UV, and HPLC/Fluorescence. The team has extensive antibody-drug conjugate (ADC) experience with various payloads and linkers. We develop assays that maintain stability for the intact ADC while analyzing for free payload. The team has extensive experience with challenging matrices such as lung and skin tissue and BAL fluid.

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Large Molecule Bioanalysis

Large molecule bioanalysis for proteins, fusion proteins, oligonucleotides, monoclonal antibodies (mAbs), and antibody drug conjugates (ADCs) including both total ADC by total payload analysis and total antibody using digestion to a signature peptide. ADCs with non-cleavable linkers have been digested using various enzymes to determine total ADC concentration in a variety of tissues in addition to serum or plasma. Using the KingFisher instruments and magnetic beads, many extractions can be automated for high-throughput sample analysis.

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Specimen Collection Kits

Assembly and distribution of protocol-specific specimen collection kits to streamline the PK collection process for single and multi-site clinical trials. Kits are tailored to your specific sampling needs. Custom stabilization can be developed and supported for sample collection to ensure accurate and reproducible PK results. Combined with our expertise in method development, other modifiers for urine and CSF collection can be provided to ensure compound solubility for small molecules.

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DMPK Assays

Industry-standard drug metabolism assays, custom research, and IND-enabling studies to assess drug-drug interaction potential, metabolic stability, metabolite profiling, and protein binding. Leveraging extensive experience handling a wide variety of tissue types, the DMPK team also supports tissue distribution studies using cold compounds.

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Method Development and Validation

Method Development or method transfers followed byregulatory compliant method validations, for small and large molecule drugs, proteins, peptides, and a wide range of biomarkers using LC/MS/MS, HPLC/UV, HPLC/fluorescence, as well as enzymatic activity methods. All performed in accordance with USFDA and ICH M10 standards, and any other regulatory agencies, as required per protocol.

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Pharmacokinetic Analysis and Reports

Pharmacokinetic (PK) and toxicokinetic (TK) data analysis for discovery, preclinical, and clinical studies. We perform model dependent or model independent analyses to calculate bioequivalence, drug exposure, and drug data recovery. The PK/TK team in San Diego also supports SEND compliant data transfers for both the PC and PP domains as required by the USFDA.

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Protein Binding Assays

Determine the extent of drug binding to plasma and/or tissue proteins during the drug development process. We measure drug-protein binding characteristics to develop a specific and sensitive quantitative method. Protein binding can be performed using ultrafiltration, ultracentrifugation and rapid equilibrium dialysis based on the properties of the compound(s) of interest and needs of the client.

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Dose Formulation Analysis

High quality analysis of preclinical dose formulations for GLP and non-GLP toxicology studies. We conduct formulation sample analysis to assess stability, homogeneity, and to discover solubility issues.

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Biomarker Assays

Biomarker assay development and validation or fit for purpose qualification for small molecule and protein biomarkers using LC/MS/MS or HRMS detection.

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Transfer and Validation of Flow Cytometry Assay Across Platforms and Labs

Speaker: Manoj Baskaran | Scientist III

Wednesday, July 24, 2024

3:45 -4:00 PM

Location: Salon III

Validation Best Practices: PCR Case Studies in Shedding

Speaker: Bryan Gullick, Ph.D. | Director

Wednesday, July 24, 2024

2:35 – 3:05 PM

Location: Salon II

MicroConstants to join the BioAgilytix family

Read the whole story here.
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Customized approaches to support your bioanalytical needs

As a leading global bioanalytical laboratory, we provide established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC bioanalytical testing services in a GxP environment.

  • Our scientific expertise and state-of-the-art instrumentation result in high-quality, tailored services to meet your bioanalytical needs.
  • Accurately measure the immunogenicity and pharmacokinetics (PK) of your biotherapeutics and advanced modalities
  • Detect your drug product or it’s downstream effects with an experienced molecular assay partner
  • Rely on services backed by global good manufacturing practices (GMP)
  • Access our vast biomarker experience to better understand the PD of your therapeutic

Ready to Start Your Project? Have a Question?

Our scientists are available to discuss how our bioanalytical CRO can help you streamline the drug development process through specialized expertise in regulated bioanalysis, DMPK, and pharmacokinetic analysis.