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.
The Year in Review 2023
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.
Top 10 Life Science Resources - October 2023
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!
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
ISSUE NO. 37 — Quantitative PCR (qPCR) and Droplet Digital (ddPCR): Leading-Edge Analysis for Your Gene Therapy Programs
The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. The goal is to safely incorporate genetic alterations to restore and repair the proteins of missing and/or faulty genes. Gene therapy requires DNA and/or RNA delivery and analysis, and while most ongoing research involves therapies being delivered in vivo via adeno-associated viral (AAV) vectors, other in vivo delivery methods are on the rise.
Quantitative, digital, and reverse transcription polymerase chain reactions (qPCR, dPCR, and RT-PCR, respectively) are fast and cost-effective techniques employed by Altasciences. These methods are invaluable for quantitative analysis of gene expression and for analyzing genetic variation in amplified DNA and RNA. This ability to analyze variation from limited samples has made genetic diagnosis easier than ever. But how are PCR analysis techniques applied? And how are they incorporated into studies?
Issue 37 of The Altascientist takes a closer look at these techniques, with in-depth information on:
- qPCR, dPCR, and RT-PCR and their utilities—including droplet digital PCR (ddPCR);
- regulatory considerations;
- PCR applications, advantages, and comparisons; and
- case studies.
HOW DOES PCR WORK?
PCR is a laboratory technique for rapidly amplifying millions of copies of specific DNA segments to be studied in greater detail. The process utilizes short synthetic DNA fragments called primers to choose a section of the genome to be amplified. Multiple rounds of DNA synthesis will then take place to amplify that section. This process is done using thermal cycling of a reagent cocktail. Reactions contain buffers to ease the DNA polymerase enzymatic amplification of nucleic acids, and target-specific primers and probes. Primers and fluorescent probes are designed and optimized for each assay and platform, to determine the appropriate region or target for amplification.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to The Altascientist: Audiobooks on Spotify, Apple Podcasts, or wherever you get your audio content.
Altasciences' Facilities: Moving in Unison
Choosing the Best Bioanalytical Platform for Your Program
Choosing the right bioanalytical platform for your molecule’s intended use and program segment is crucial to obtaining reliable, robust data in a timely manner.
Microsampling for Pediatric Baricitinib Pharmacokinetics