Bioanalysis
Q&A With Dr. Norbert Makori and Pierre Jolicoeur: The Benefits of Combining Preclinical and Bioanalytical Solutions for Your Gene Therapy Studies
Recent advances in gene therapy have allowed for diseases to be approached differently. Gene therapy was first discovered in the 1960s, but only gained commercial interest in the 1980s. It wasn’t until 1990 that the first successful gene therapy treatment on a patient transpired.
Strategic Biomarker Integration
Optimizing Drug Development With Biomarkers
The strategic integration of biomarkers into the drug development process empowers sponsors with critical information at every stage.
Altasciences’ biomarker services provide insight into a drug’s efficacy, safety, and mechanism of action, where we can translate findings into clinical applications and beyond, resulting in reduced timelines.
Our Laboratory Sciences team has the scientific, operational, and regulatory acumen to offer pre-existing validated assays in multiple species and matrices, and can develop new methods to meet your needs.
Is the assay you are looking for missing? Contact us to discuss how we can support your specific needs.
You may also be interested in the below resources:
Fact Sheets
• Flow Cytometry Services
• Immunogenicity Testing
• Immunomodulatory Drugs
eBooks
• Key Biomarkers of Immunomodulation
• Altasciences' Proactive Drug Development Solution: Large Molecules
Poster Presentation
• Immunogenicity Target Interference: A Novel Blocking Approach
Laboratory Sciences Resource Library
A Wealth of Information at Your Fingertips
Explore Altasciences’ bioanalytical resources for comprehensive solutions tailored to your specific requirements. Altasciences’ bioanalytical team specializes in assay development from discovery to preclinical to Phase IV for both small and large molecules.
The Altascientist—A Scientific Journal
The Evolution and Advancement of Liquid Chromatography-Mass Spectrometry in Drug Development. Read or listen to the issue>>>
Validation of Immunogenicity Assays. Read or listen to the issue>>>
Microsampling in Drug Development. Read or listen to the issue>>>
eBook
Key Biomarkers of Immunomodulation. Read or listen to the eBook>>>
Webinars
Uses of Digital Droplet PCR (ddPCR) in Preclinical Research. Watch the webinar>>>
Development of a Cell-Based Assay for Dual Purposes: to Support Drug Potency and Characterize Immunogenicity. Watch the webinar>>>
Speak with an expert today to learn more about our bioanalytical solution.
Have five more minutes? Check out these webpages:
Bioanalytical Services
Assay List
Supporting the Future of Immunomodulatory Drugs
Achieve Critical Milestones in Your Drug Development Program
At Altasciences, we specialize in diverse immunomodulators, including proteins, oligonucleotides, biologics, bispecific antibodies, and gene therapy.
Our evaluations count on essential biomarkers, like cytokines, complement factors, immune cell subtyping, and functional measurements.
Rely on us for:
- precise drug quantitation and biomarker assessment;
- state-of-the-art bioanalytical platforms to monitor multiple aspects of immunomodulation in various species;
- bioanalytical teams with relevant experience handling pathogens and working with infectious samples for your vaccine development programs; and
- labs equipped with containment Level 2 (CL2) areas for handling pathogens within the Risk Group 2.
Need more guidance? Send us a message.
You may also be interested in the below resources:
Fact Sheet: Immunogenicity Testing
eBook: Key Biomarkers of Immunomodulation
Webpage: Bioanalytical Platforms
Accelerating Decentralized Clinical Trials with Precise ASO Analysis
In this poster presentation, Dr. Mingluan Chen discusses the first successful application leveraging the Capitainer® qDBS device, for the quantitative bioanalysis of Fomivirsen ASO and its 5’ n-1 metabolite from dried blood micro samples using a hybridization LC-MS/MS workflow.
The ability to quantify ASOs accurately and efficiently in dried blood samples means critical patient populations may be more readily accessible for decentralized clinical trials. This can lead to faster, more efficient research and improved patient outcomes.
You may also be interested in the below resources:
Webpages:
Research Articles:
Accurate Quantification of ASOs in Mouse Serum Using Microsampling LC-MS/MS
Poster Presentations:
Application of Mitra® Microsampling for the Quantitative Bioanalysis of ASOs
Altasciences Completes Expansion of New State-Of-The-Art Laboratory in Columbia, Missouri
Laval, Québec, October 31, 2023 – Altasciences is pleased to announce the completion of its laboratory facilities in Columbia, MO.
The newly expanded, 8,000-square-foot space, which includes a test material department, features
state-of-the-art equipment and forty-eight workbenches, with a vast range of services, including ligand binding assays, flow cytometry, biomarker analysis, and cell culture capabilities.
“This laboratory expansion is a significant step forward in our ability to meet the increasing needs of sponsors. Our focus on growing our bioanalytical capabilities highlights Altasciences' mission to help develop potentially life-saving therapeutics, and get them to market faster,” said Marie-Hélène Raigneau, Co-chief Operating Officer, Altasciences. “Our integrated CRO/CDMO services combine bioanalytical services with preclinical and clinical study solutions, manufacturing services, and all complementary research support services, for maximum efficiency.”
This is Altasciences’ third purpose-built laboratory. Altasciences’ laboratory sciences has the scientific, regulatory, and operational expertise for quantitation of drugs and biomarkers from discovery to preclinical to Phase IV, using bioanalysis platforms including mass spectrometry, ligand binding assay, PCR, flow cytometry, ELISpot, and cell based assays in routine and specialized areas such as immunomodulation and cell and gene therapy. All three laboratories across North America are uniformly designed and managed.
Whether as a standalone bioanalytical service or as part of an integrated program, Altasciences provides top-quality data for TK, PK, and PD determinations to support preclinical and clinical studies.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
Retrospective Safety Evaluation of Tyrosine Kinase Inhibitor Products When Administered in Single Dose in Crossover Studies to Healthy Volunteers
Quantitation of Bemnifosbuvir and Metabolites in Human Bronchoalveolar Lavage by LC-MS/MS
PCR's Key Role in Therapeutic Advancements
Cell and gene therapies are revolutionizing medicine with personalized treatments; PCR analysis plays a crucial role in their development.
In this issue of The Altascientist:
- explore the different approaches and applications of qPCR and ddPCR analysis for nonclinical and clinical studies;
- discover the unique advantages they offer; and
- review two case studies demonstrating how these methods are shaping the future of gene therapy research.
Have questions? Speak to a scientist.
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.