
[EPISODE 25] Adam Stasio Talks, Large Data Sets, Breaking Down Problems, and Tech-Driven Solutions
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
~34,000 sq. ft.
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
~265,000 sq. ft.
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
~22,000 sq. ft.
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
~2,900 m2 (31,000 sq. ft.)
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry
In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
PCR platforms and Good Manufacturing Practices (GMP) certification further enhance European service offerings HAMBURG, GERMANY and DURHAM, NC, May 8,
BioAgilytix continues to build leadership in Europe. Hamburg, Germany April 3, 2023 – BioAgilytix, a leading global bioanalytical laboratory, today
This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry
As we continue our blog series on flow cytometry, we’ll now dive into how this powerful capability supports multiple types
Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
~34,000 sq. ft.
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
~265,000 sq. ft.
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
~22,000 sq. ft.
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
~2,900 m2 (31,000 sq. ft.)
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry
In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
PCR platforms and Good Manufacturing Practices (GMP) certification further enhance European service offerings HAMBURG, GERMANY and DURHAM, NC, May 8,
BioAgilytix continues to build leadership in Europe. Hamburg, Germany April 3, 2023 – BioAgilytix, a leading global bioanalytical laboratory, today
This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry
As we continue our blog series on flow cytometry, we’ll now dive into how this powerful capability supports multiple types
Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
Through our toxicology studies, BioAgilytix is able to help our clients characterize the potential extent of injury that a biologic could produce at varied dosages, and predict the consequences of such injury to understand the risk / benefit equation of the drug candidate in terms of toxicity and efficacy. We are able to conduct both non-GLP and GLP toxicology studies, depending on customer needs and phase of development.
Toxicology studies are used to characterize the toxicity profile of a drug by identifying its impact on organ structure and / or functionality. This includes assessment of the severity and reversibility of toxicity, as well as dose ranges and their relationship to exposure. Ultimately, these toxicology studies aid in determining if, and to what degree, the biologic’s toxicity is dose-dependent, species-specific, mechanism-related and / or related to the method of administration.
By understanding the injuries that could occur to kidneys, the heart, muscles, and other vital organs, toxicology studies help to determine the margin of safety of a drug for its expected clinical dose. This information is key in guiding the parameters for clinical trials to maximize safety and minimize risk. Not only do toxicology studies frame trial guidance related to duration, administration routes, and dose escalation, they also help to set the parameters for clinical monitoring (i.e., which organs to assess closely).
The purpose of this study was to evaluate the Cardiac Injury Panel 2 Assay Kit, a multiplex 96-well electrochemiluminescent immunoassay from MSD for the determination of cTnI, cTnT, and fatty acid binding protein 3 (FABP 3) in rat serum.
BioAgilytix conducts both non-GLP and GLP toxicology studies, depending on customer needs and phase of drug development. We can assist early in the drug development process to assess the probability of success for the novel compound in question, providing insight into potential toxicity concerns before significant time and cost are invested. This helps to ensure our clients can anticipate and respond to toxicology-related challenges sooner, and prioritize the most promising compounds for advancement.
As the biologic moves through the preclinical program, BioAgilytix is able to perform acute single dose toxicity testing to define and characterize its intrinsic toxicities, as well as generate data to establish acute exposure. This information is paired with dose range finding assessments, which are critical to understanding human risk. By measuring the impact at low, high, and intermediate doses, our team can demonstrate the no observed adverse effect level (NOAEL), which determines the highest dosage level at which chronic exposure to the substance shows no adverse effects, and the no observed effect level (NOEL), which reveals the dose-response relationship. GLP-compliant toxicology studies are mandatory to provide data to regulatory authorities when requesting permission to commence human clinical trials, and BioAgilytix is a GLP/GMP bioanalytical laboratory fully adhering to all GLP procedural standards, principles, and processes.
Download this helpful resource to discover the 8 key selection criteria you should consider when evaluating a bioanalytical CRO to ensure a successful partnership.
BioAgilytix’s scientific team has extensive experience conducting toxicology studies, using enzymatic assays and immunoassays to support kidney, cardiac, and muscle injury in a variety of matrices, including serum, plasma, and urine. In fact, over half of our scientists boast over 15 years of experience performing both non-GLP toxicology studies and GLP toxicology studies in full compliance with GLP regulations.
The risk assessment done using toxicology studies is vital to characterize potential adverse effects that may occur, and to estimate a safe starting dose and dosage regimen as guidance for clinical trials. BioAgilytix will conduct both standard and customized toxicology studies to meet your safety assessment needs as well as your regulatory requirements.
Leverage the expertise of BioAgilytix’s veteran team to deliver robust toxicity testing results with streamlined turnaround.