Bioanalysis
Quantification of Endogenous Biomarkers in Biological Matrices
The quantitation of endogenous compounds in biological methods requires reliable validated assays. Using the required surrogate reference standard (in most cases a recombinant reference standard that allows the relative quantitation of the endogenous analyte) can be challenging. To assess the suitability of the reference standard you need to demonstrate acceptable parallelism between the endogenous analyte and the calibration curve upon multiple dilutions. Our team can help!
Download this insert to find out more about the approaches used by Altasciences to validate and monitor assay performance.
Contact our bioanalytical scientists today for your customized experience.
You may also be interested in the following:
- Webinar: Certificate of Analysis Essentials for Regulated Bioanalysis
- Webinar: Selectivity, Selectivity, Selectivity — a New Dimension by Differential Mobility Spectrometry
- Webpage: Bioanalytical Assay List
- Webpage: Translational Biomarkers
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Leveraging the Benefits of Microsampling for Safety and Convenience
In a previous blog, we provided an overview of microsampling technology for preclinica
25+ Years’ Experience Conducting Early Phase Drug Development
One of the most significant milestones in drug development research is the transition from preclinical to clinical studies. Ensuring risk mitigation at all steps of preclinical and clinical testing, as well as incorporating a thorough safety review plan in the clinical setting, is integral.
Altasciences applies recommendations from world-wide regulatory agencies to ensure that studies are conducted safely, ethically, and in a scientifically robust manner.
We facilitate drug development and save you time by:
- Preparing your preclinical study designs, including species selection and dose level determination.
- Conducting the required safety testing and updating your Investigational Brochure while your IND/CTA-enabling studies are in progress.
- Writing your IND/CTA applications.
- Planning your clinical program while your preclinical safety assessment is ongoing so that you can initiate your first-in-human (FIH) trials as soon as you receive regulatory approval.
- Designing your FIH clinical protocol using preclinical study data, including identifying the maximum safe starting doses.
- Timing small-scale drug formulations with clinical conduct to get your trials started sooner.
- Conducting your FIH trials and making quick, informed dosing decisions based on timed bioanalytical data and safety data available within 48 hours.
- Quickly identifying trial findings that may allow you to waive certain studies or provide critical data for safety/dosing considerations in subsequent clinical studies.
Our preclinical, manufacturing, bioanalytical, and clinical teams work closely together to transition drugs through the critical early phases of drug development.
Speak with our experts.
You may also be interested in the following:
- Video: Your Road to Proactive Drug Development with Altasciences
- Webpage: Scientific, Regulatory and Strategic Guidance
- Webpage: Full-Time Equivalent (FTE) Capabilities
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Q&A Session with Dr. Danielle Salha
Renowned for our full-service offering, we often get asked — how does Altasciences manage the development process for biologics and biosimilars so seamlessly from the require
Bioanalytical Methods for Vaccine Assessment
Altasciences performs robust, bioanalytical assessments according to GLP and GCP regulations for a wide range of vaccine types, including: adjuvanted recombinant proteins, virus-like particles, and nucleic acid- or vector-based vaccines.
We apply our extensive expertise in diverse and complex biological matrices by utilizing broad platform capabilities, for the development of optimal, phase-appropriate methods that meet your unique vaccine program needs, such as:
- Flow Cytometry
- ELISA
- Cell-Based Functional Assays
- Meso Scale Discovery
- Real-Time PCR (qPCR) & Digital Droplet PCR (ddPCR)
Contact our scientists today.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
You may also be interested in the following:
- Fact Sheet: First-in-Human (FIH) Trials
- Webpage: Preclinical Drug Development Solutions
- Fact Sheet: Comprehensive Research Support
Accelerate your Biologic/Biosimilar Program with Altasciences Laboratory Sciences
Your biologic or biosimilar drug development program deserves the best chance of success. Altasciences has demonstrated expertise and decades of experience in the development of large molecules, from preclinical safety testing to clinical proof of concept, including robust bioanalytical support, project management, and medical writing.
We have a wide range of large molecule bioanalytical capabilities, using both ligand binding and mass spectrometry platforms :
- Method development
- GCP/GLP-compliant biosimilar assay development and validation
- Sample analysis for PK and immunogenicity/anti-drug antibody (ADA) testing
To know more, please consult:
Our Q&A Session with Dr. Danielle Salha, Senior Director, Immunology and Immunochemistry, Ligand Binding Assays
The Altascientist, a scientific journal with detailed discussion of our bioanalytical capabilities (LC-MS/MS and Ligand Binding)
Contact our experts today for a customized experience.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept.
You may also be interested in the following:
Bioanalytical Methods for Vaccine Assessment
Altasciences performs robust, bioanalytical assessments according to GLP and GCP regulations for a wide range of vaccine types, including: adjuvanted recombinant proteins, virus-like particles, and nucleic acid- or vector-based vaccines.
We apply our extensive expertise in diverse and complex biological matrices by utilizing broad platform capabilities, for the development of optimal, phase-appropriate methods that meet your unique vaccine program needs, such as:
- Flow Cytometry
- ELISA
- Cell-Based Functional Assays
- Meso Scale Discovery
- Real-Time PCR (qPCR) & Digital Droplet PCR (ddPCR)
Contact our scientists today.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
You may also be interested in the following:
- Fact Sheet: First-in-Human (FIH) Trials
- Webpage: Preclinical Drug Development Solutions
- Fact Sheet: Comprehensive Research Support
Three Laboratories — One Vision
Podcast with Dr. Lynne Le Sauteur
In this podcast, we sit down with Dr. Lynne Le Sauteur to discuss Altasciences’ laboratory vision. When we share knowledge, data, and innovation between groups and stages as your project advances, you benefit from data-driven decision making, from inquiry to completion. Listen in as Dr. Le Sauteur describes a real-life case study on Altasciences conducting a small molecule, Phase I study identifying novel metabolites.
Dr. Le Sauteur received her PhD in Pharmacology and Therapeutics from McGill University and has over 20 years’ experience in biologic drug development. As Vice President of Laboratory Sciences, Dr. Le Sauteur leads over 260 experts specialized in bioanalysis, ligand binding assays, mass spectrometry, immunology, biomarkers, and PCR. Altasciences’ bioanalytical laboratories are located in Laval, Canada, and Seattle, U.S.A., and its team has over 25 years of scientific and QA experience, delivering world-leading science, proven data integrity and global regulatory expertise to support both small and large molecule programs.
For access to all our podcasts and webinars, click here.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
You may also be interested in the following:
The Altascientist: Safety Pharmacology Guidelines and Practices
Webinar: Quantitation of Passive Immunotherapeutic Agents
Scientific Poster: Assessment of Receptor Occupancy via Flow Cytometry
Bioanalytical Solutions for Biomarkers
Altasciences supports both preclinical and clinical studies covering many disease indications, such as oncology, metabolic disease, neurology, diabetes, inflammation, and more. Our integrated approach involves bringing in toxicologists and clinical pharmacologists to develop a comprehensive preclinical to clinical plan to maximize the translation of results from one phase to the next.
We will help guide you towards a robust and effective biomarker solution, using state-of-the-art technologies that include:
- Mass spectrometry
- Flow cytometry
- Cell-based assays
- Immunoassays
- Quantitative PCR
- Immunohistochemistry
Discover the difference.
Questions? Speak with our scientists.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
You may also be interested in the following:
Over 20 Years of Bioanalytical Expertise
From discovery to preclinical to Phase IV, our team of over 200 highly skilled bioanalytical experts are ready to help you with your bioanalytical needs.
We deliver world-leading science, proven data integrity, regulatory expertise, and use state-of-the-art instrumentation to support both small and large molecule bioanalytical programs, including:
- Small and large molecule LC-MS/MS
- Microsampling
- Ligand binding assays
- Cell-based assays
- Biomarker quantitation
- Immunogenicity assessments
- Kit preparation
Find out more about how Altasciences can help you with your bioanalytical needs.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept.
You may also be interested in the following: