Bioanalysis
A Novel Method for Performing Linearity Assessments in Whole Blood Prepared Using a Lyse/No Wash Procedure
[NEW PODCAST] Microsampling: When Small Steps Lead to Big Outcomes
Microsampling: When Small Steps Lead to Big Outcomes
Join us as Dr. Donald Chace and Jeff Plomley discuss the many advantages of incorporating microsampling into your drug development program.
Altasciences is at the forefront of microsampling, leveraging innovative technology that allows for significantly reduced blood volumes to be taken from test subjects for analysis. Our experts have developed specialized workflows and methods to take full advantage of current microsampling technology at the preclinical, clinical, and bioanalytical levels, supporting the efficient advancement of your drug development program. Our services are fully customizable, available as stand-alone, or as part of a complete development program.
You may also be interested in the following:
- The Altascientist: Microsampling in Drug Development
- Webpage: Patient Centricity and the Evolving Role of Microsampling
- Webpage: Comprehensive Bioanalytical Services
- PDF: Altasciences' Proprietary Bioanalytical Assay List
Transforming the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, Altasciences offers a unique integrated approach to CRO and CDMO s
Flow Lab—Minutes Away From our Clinical Unit
Benefits of Partnering with Altasciences for Your Flow Cytometry Services
Our bioanalytical laboratory is located 15 minutes from our Montréal clinical pharmacology unit, creating an efficient process that allows rapid turnaround time between sample collection and analysis.
The close proximity between the clinic and our lab:
- prevents potential risks at the primary endpoints of these types of trials
- certifies rapid results analysis and reporting
- ensures safe and seamless dose escalations for FIH trials
- proven to lower costs
To safely expedite the bioanalytical phase of your preclinical or clinical study or program, our flow cytometry services will help you get there.
Book a consult with one of our experts today, to discuss how we can support your single study or program.
You may also be interested in the following:
- Webpage:
- Podcast:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programmes, to offer an integrated/synchronized approach to CRO and CDMO services.
Managing Challenging Bioanalysis for PK/PD Assessments for Phase I Biologics Studies
How to Maximize Drug Development Success of Biologics
Combining Phase I trial conduct of biologics and bioanalysis is critical for successful drug development. Clinical development relies heavily on bioanalytical experts to generate critical data to understand pharmacokinetics and pharmacodynamics.
Here are just some of the benefits of working with Altasciences:
- Timed interim sample analysis for dose escalation decisions
- Rapid turnaround of PK/PD analysis between cohorts
- Biomarker development and validation for exploratory or primary endpoints
- On-site flow cytometry
- Centralized scheduling between clinic and lab
- Ability to easily switch or combine platforms which are sensitive, have high throughput, and demonstrate exquisite specificity
Watch this complimentary webinar to see how you can overcome challenges throughout all phases of drug development.
Have 5 minutes? Take a look at these:
- How Is Partnering with Altasciences for Your First-in-Human Clinical Trials Different?
- Microsampling in Drug Development
- Validated Bioanalytical Assay List
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for 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.
Making Sense of Antisense Oligonucleotides (ASOs)
ASOs — The Importance of Sensitive Bioanalytical Assays
Precise quantitation of ASOs helps you target the source of a disease’s pathogenesis. Chemical modifications of ASOs and advancements in drug delivery have improved drug stability and potency, reducing the requirements for quantity of drug per dose, and total number of doses.
Altasciences has expertise in the development of highly sensitive bioanalytical assays for the quantitation of ASOs in complex biological matrices such as eye, liver, or brain tissue, adapted to the different critical parameters of your preclinical or clinical study:
- The ability to quantitate ASOs to very low concentrations impacts calculation of half-life; more sensitive assays will produce more accurate readouts.
- Timepoints close to the end of the dosing cycle are expected to have lower concentrations in various tissues. Highly sensitive methods will produce the most accurate readings, allowing for an accurate PK profile even in late timepoints.
- Hybridization-based methods provide the best reported assay sensitivity and throughput, compared with other bioanalytical methods for ASOs. They are less time consuming, requiring little or no sample clean-up, and have been widely used for the quantitative analysis of ASOs to support both TK and PK regulated bioanalysis.
Take a deeper dive into our ASO capabilities and knowledge, and consult our two case studies, in the 12th issue of The Altascientist.
Want more info?
- Webpage: Comprehensive Bioanalytical Services
- PDF: Altasciences' Proprietary Bioanalytical Assay List
- Podcast: Three Laboratories — One Vision
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
eBook – Monitoring Key Biomarkers of Immunomodulation
Altasciences has published a new eBook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
With the movement toward personalized treatments having immunomodulatory effects, monitoring complement factors and cytokines has become increasingly important to help prevent any unintended consequences that may arise from these new medications.
Contents include:
- REVIEW: Complement Factors and Cytokines
- SOLUTIONS: Biomarker Analysis
- CASE STUDY: Comparing Cytokine Data to In-Life Parameters on Nonhuman Primates in Nonclinical Toxicology Studies
- STUDY OUTLINE TEMPLATE: Nonclinical Study
Altasciences has been delivering excellence in bioanalytical services for over 25 years, and is fully equipped to analyze a comprehensive range of biomarkers to support your nonclinical toxicology programs. With over 260 scientists working in state-of-the-art laboratories and shifts running 24/7, as needed, our laboratory teams are able to process as many as 60,000 samples per month.
You may also be interested in the following:
- Poster: Multiplexed Cytokine Comparison Across Two Species Dosed With the Same Drug
- Poster: Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for 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.
NEW SCIENTIFIC PUBLICATION — Achieve Robust and Accurate Study Results
Robust Sample Management
Read our latest issue of The Altascientist to better understand how we deliver reliable study results through robust sample management for your preclinical and Phase I to IV clinical studies, including:
- Customized processes
- Controlled environments
- Standardized workflows for risk management
- Capability to handle a wide variety of matrices
- Stability testing
Download your copy, or listen to the audiobook today.
You may also be interested in the following:
Webinars:
- Sample Collection Kits and Lab Manual
- Bioanalytical Project Management
- Critical Sample Handling Processes for Clinical and Preclinical Studies
Podcast:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Key Biomarkers of Immunomodulation: Complement Factors and Cytokines
Three Scientific Posters for You
15th Annual WRIB Meeting Recap on Immunogenicity
Have a look at these three scientific posters that were presented by our scientific experts at the 15th WRIB (Workshops on Recent Issues in Bioanalysis):
Dual Purpose of a Cell-Based Assay for an Agonist of the GLP-2 Receptor
During drug development, cell-based assays are used for multiple purposes. These include early proof of concept to identify a drug product’s pharmacological activity, and further studies to determine whether neutralizing anti-drug antibodies (NAbs) are present.
Read more.
Development of an Oligonucleotide Drug Immunogenicity Assay: a Case for the Characterization of the Immune Response
While the immunogenicity of protein-based biologics and the characteristics of the antibody responses directed against them are well understood, the same is not true for other categories of biologics.
Read more.
Using Anti-Drug-Antibody Screening Assay to Resolve Selectivity Issues in Toxicokinetic Ligand-Binding Assay
Selectivity evaluation for regulatory toxicokinetic (TK) quantitative ligand binding assays (LBAs) is required to meet accuracy requirements for at least 80% of the individual selectivity matrix lots.
Read more.
Through different techniques, our experts will help you determine the best possible approach for your molecule, and select the optimal platform to produce high-quality results. Book a consult with one of our experts to discuss how we can support your program.
You may also be interested in the following:
- Webpages:
- Podcast:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.