Bioanalysis
Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development
The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
The Year in Review 2024
Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services
Greater Montréal, Québec, 11/13, 2024 — Altasciences, a trusted drug development research partner for over 30 years, continues its commitment to providing world-class bioanalytical services. This core business supports both preclinical and clinical studies conducted at Altasciences’ facilities, while also offering an extensive standalone solution to meet the diverse needs of clients. By delivering high-quality, flexible bioanalytical services, Altasciences remains dedicated to advancing drug development and empowering clients across every phase of research.
For three decades now, Altasciences has taken pride in evolving their solutions to meet the needs of pharmaceutical and biotechnology companies of all sizes, including the expansion of their labs in Seattle, WA, Columbia, MO, and Laval, Quebec. Their three state-of-the-art bioanalytical laboratories feature mirrored operations and uniform protocols to maintain consistency and quality across client projects, ensuring reliable, high-quality data regardless of location. This high level of harmonization enables the seamless transfer and sharing of methods across its multiple laboratory sites, allowing the analysis of hundreds of thousands of samples efficiently.
“Our extensive bioanalytical offerings are designed to support both standalone projects and Altasciences' integrated drug development solutions. Whether for preclinical or clinical studies, we provide tailored solutions to meet specific research needs. At Altasciences, we’re committed to facilitating every phase of the scientific journey with precision and care,” said Dr. Lynne Le Sauteur, Vice President of Laboratory Sciences at Altasciences.
Altasciences’ bioanalytical services are built around a comprehensive suite of capabilities tailored for both small and large molecules. Core offerings include drug quantification, metabolite and biomarker analysis, and immunogenicity testing, to support and advance a molecule from discovery to market.
Altasciences’ bioanalytical approach focuses on three core pillars: understanding and anticipating client needs as scientists, creating innovative solutions, and fostering collaboration through transparent communication. This client-centered approach has helped Altasciences build lasting partnerships, assisting clients in meeting complex regulatory standards while maintaining scientific rigor.
To promote Altasciences’ bioanalytical services from discovery to Phase IV, they recently launched their Unveiling the Invisible video campaign to showcase how their bioanalytical solutions provide critical insights that unveil the invisible and drive the creation of innovative therapies.
View the fascinating video series here.
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 30 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.
Julie-Ann Cabana
Altasciences
jcabana@altasciences.com
ISSUE NO. 42 — Managing The Complexities of Glucagon-Like Peptide-1 Receptor Agonist Drug Development
Current and future development of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or simply GLP-1s, involves complexities not only in formulation but in all areas of early-phase drug development. Developing and refining preclinical models for early efficacy signals, developing and validating the bioanalytical assays necessary for quantitation, and designing the clinical studies that deliver the most robust data in this innovative therapeutic area are all key elements of a drug development program.
In Issue 42 of The Altascientist, we review the requirements for successful GLP-1 drug development, including:
- preclinical approaches
- early-phase clinical study design
- bioanalytical techniques
- manufacturing
Two case studies are also included.
The Golden Era of GLP-1 Drugs
GLP-1 RAs are entero-pancreatic hormone-based treatments, first approved in 2005 for type 2 diabetes (T2D), and now commonly prescribed for weight loss and reduction of atherosclerotic cardiovascular (CV) risk in patients with T2D.
According to a MarketsandMarkets report from July 2024, the global GLP-1 market is expected to reach $471 billion worldwide by 2032. More than one billion people worldwide are living with obesity, which increases their risk of major health complications, including T2D, high blood pressure, heart disease, stroke, metabolic syndrome, fatty liver diseases, some cancers, kidney disease, breathing problems, and sleep apnea. Most of these diseases are interrelated, with glycemic control and weight loss being a major factor in improving the overall health of sufferers.
“As we learn more about GLP-1 RAs, we realize that they target many organ systems, including the pancreas, the stomach, brain, heart, kidneys, immune system (due to reduced inflammation), and skeletal muscle. They help control the metabolism of white and brown adipose tissue and show positive effect in fatty liver disease (nonalcoholic steatohepatitis, or NASH),” says Dr. Gaetano Morelli, Chief Medical Officer at Altasciences.
What We Know So Far About GLP-1 RAs
GLP-1 RA head-to-head clinical studies have demonstrated that all GLP-1 RAs are effective at reducing A1C (the average amount of glucose in a person’s blood over the past three months). The initial pivotal studies that led to the first wave of GLP-1 RAs demonstrated that they work in several ways, including stimulating insulin release, slowing digestion, reducing appetite, and inhibiting glucagon release. These actions have made GLP-1 RAs excellent candidates for obesity treatment, where much of the new development is now focused. As with most medical breakthroughs, the development and implementation of GLP-1 RA drugs is not straightforward.
How Altasciences Can Help With Your GLP-1 Drug Development
Altasciences offers comprehensive services and support throughout the early phases of your GLP-1 RA drug development. We bring you expertise in preclinical studies, including custom diet-induced obesity (DIO) and other modified models; clinical trial design, conduct, and reporting; regulatory support; and bioanalytical testing.
With proactive communication and seamless handoffs, we ensure that your GLP-1 RA drug development program or study is efficiently managed. This includes optimizing study designs, managing compliance with regulatory standards like GLPs, and ensuring timely data collection and analysis. Such seamless coordination accelerates timelines, reduces costs, maximizes animal and participant safety, and ensures that the data meets the stringent requirements for regulatory approval.
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Top Life Science Resources for Fall 2024
There’s a lot of life science content out there, so for your convenience, we’ve curated a selection of expert insights, tips, case studies, and scientific and regulatory information. Catch up on what you might have missed below!
Development and Validation of LC-MS/MS Assay Methods to Determine Ubrogepant and Atogepant in Human Breast Milk
Implementation of a Semi-Automated Bead Extraction Procedure During Analyte Purification for High Throughput Immunogenicity Assays
Strategy to Increase Throughput and Method Sensitivity for Clinical Immunogenicity Studies
Development of a Hybridization LC-MS Methodology for Quantitation of siRNA in Cynomolgus Monkey
Quantitative Bioanalysis of HT-KIT Vivo-Morpholino Using Hybridization LC-MS/MS