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.
5 Red Flags That Show Your CRO Isn’t Giving You the Attention You Deserve
Choose a CRO Who Understands Your Worth
Like any good relationship, going steady with a CRO should be about mutual commitment, transparency, and shared goals. But what if your CRO isn’t giving you the time and effort you deserve?
Here are five red flags that show your CRO isn’t making you a priority—and how Altasciences guarantees the support you deserve.
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You always have to ask for attention.
Are you constantly chasing updates or feeling like an afterthought? It might be time to rethink your partnership. At Altasciences, we believe in the type of commitment where you never have to wonder where you stand or compete with late-phase deliverables. With a dedicated, cross-functional team by your side, you’ll always be a priority. No mixed signals—just clear, proactive updates.
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They keep changing plans on you.
You’ve agreed on dates, but they’re always running late or delaying your studies. At Altasciences, size and spend don’t matter; whether you place one study or a complete program with us, we stay true to our commitment to you. And if timeline changes are a possibility, we will be able to anticipate them and present solutions before they happen. Our customized roadmaps and centralized scheduling system facilitate active timeline management, real-time responses, and proactive communication; you’ll know what activities are taking place in real time.
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They’re making you repeat yourself.
If you’re constantly repeating information, they’re not putting in the effort to make your relationship easier. Think of partnering with Altasciences like a honeymoon period that never ends. With our proprietary database, Ask Albert, we capture and share your preferences, study requirements, drug information, and results across all departments and phases. That way, you’ll only have to Tell Us Once™.
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They’re hard to reach.
If they take eons to respond to your calls or emails, they might be giving you the runaround. At Altasciences, you’ll never feel ignored. With a central point of contact, the same program managers will stick with you for your entire journey with us. And if you ever need extra insight, our executive team is just a call away. No games—just a partner who’s always within reach.
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They’re all talk.
Promises are great, but if your CRO keeps making commitments they can’t keep, it’s time to re-evaluate.
Altasciences won’t ghost you for the next big crush; you are our partner, not a simple transaction. We are a CRO/CDMO that’s fully committed to you and your project, and we believe in transparency, responsiveness, and the importance of being dependable and honest. You deserve nothing less.
Discover how Altasciences could be the right CRO for you:
VIDEO:The True Meaning of Moving in Unison
Ingrid Holmes, VP of Global Clinical Operations, and Lynne Le Sauteur, VP of Laboratory Sciences, discuss how the synergy between our clinical and bioanalytical teams drives our integrated solution.
BLOG: 4 Essential Topics to Cover in Your First CRO Meeting
Chad Rathlef, Executive Director of Strategic Partnerships, and Lisa Sanford, VP of Business Development, outline how to navigate this pivotal moment and set yourself up for a long-lasting partnership.
VIDEO: QUICK CHAT with Chris Perkin—One Operational Structure
Altasciences' CEO, Chris Perkin, discusses how our internal structure differs from other CROs and CDMOs, and how this addresses a major challenge within the industry and accelerates timelines for clients.
Immunogenicity Data Delivered Without Delay
Preclinical Assays for Immunogenicity Testing in Clinical Trials
Whether developing a vaccine, biologic, or gene therapy, immunogenicity testing is required for regulatory approval and is critical for determining the safety and efficacy of your product.
Our scientific experts will ensure your nonclinical assays are adapted and validated for your clinical trials, with a tailored bioanalytical program designed for your drug type and study purpose. We focus on the right PK/PD endpoints to ensure regulatory and bioanalytical standards are met.
For more information on assessing immunogenicity, please browse and bookmark these resources.
A Comprehensive Guide to Immunomodulation
In this issue, find out more about the standard classes of immunomodulators, advanced bioanalytical methods, and case studies with practical insights.
Purposes and Challenges for Nonclinical and Clinical Studies
In this edition of The Altascientist, learn about the different purposes and challenges of validating immunogenicity assays to strategically develop a safe and quick approach to support nonclinical and clinical studies.
Challenges Encountered in Anti-Drug Antibody Assays
Find out how we have implemented strategies to overcome matrix interferences observed in disease populations. This allows us to assess immunogenicity in complex clinical studies targeting diverse populations, ensuring a comprehensive understanding of each therapeutic's impact.
Tailored Immunogenicity Testing Services
We cover all essential assays, from characterization to binding specificity, isotyping, and NAbs, while ensuring our approach is adapted to your drug's mechanism of action.
Ready to book your study or have a question about your study? Speak with one of our experts.
From AAV to Biomarkers—Your 2025 Roadmap
Support for Your Early-Phase Gene Therapy Program
At Altasciences, we are committed to advancing gene therapies with precision and efficiency. In addition to hundreds of pre-screened AAV nonhuman primates (NHPs) available for gene therapy programs and decades of bioanalytical, nonclinical, and clinical expertise―we’ve compiled a comprehensive list of resources below:
A Comprehensive Guide to Gene Therapy and Improving AAV Efficiency
Learn more about our track record, expertise in navigating regulatory requirements, and how we ensure the safety and efficacy of AAV-based therapies (three case studies included).
In-House AAV Pre-Screening
Detailed information on our in-house AAV pre-screening methods for removing nonhuman primates from toxicology studies if they have antibodies against AAV8 serotypes. It covers two main assays: total antibody screening (TAb) and neutralizing antibody screening (NAb).
Expert Insights on Cell and Gene Therapy Development
This scientific journal reviews considerations for nonclinical cell and gene therapy development, including expert approaches to mitigate complex challenges, improve study efficiency, and maximize translational opportunities to first-in-human trials.
Altasciences’ Biomarkers by Indication
Our expertise in biomarker analysis supports critical go/no-go decision making by providing insight into a drug’s efficacy, safety, and mechanism of action. Assessed early in the drug development process, biomarker assays can validate targets and identify potential toxicity.
Ready to get your gene therapy development program started? Speak with one of our experts.
Hot off the Press! - November 2024
Altasciences Supports Metsera in Their Early Stage Clinical Trials for Obesity
Altasciences is proud to have supported Metsera, Inc., a clinical stage biopharmaceutical company, with nonclinical and early-stage clinical trials. This support includes a recent Phase I/II trial of MET-097i: an ultra-long-acting injectable amylin analog and fully biased GLP-1 receptor agonist.
In a trial conducted at our clinic, Metsera reported positive topline results. This study enabled Metsera to initiate a randomized 16-week Phase II trial of MET-097i, which could offer potential new treatment options for those affected by obesity. We also further supported Metsera with our proactive drug development solution, providing nonclinical, bioanalysis, CRO, and program management services for several other therapeutic candidates.
Altasciences Upholds Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services
A trusted drug development research partner for over 30 years, Altasciences remains committed to providing world-class bioanalytical services in support of the preclinical and clinical studies conducted at our cutting-edge facilities, as well as extensive standalone solutions to meet your diverse needs.
Our flexible bioanalytical services from discovery to Phase IV empower clients across every phase of research.
Let's Promote Your Project!
Interested in a custom press release, written by our experts, to feature the great research we do together? Email us to get started!
You may also be interested in:
- The Altascientist Issue No.42: Managing the Complexities of Glucagon-Like Peptide-1 Receptor Agonist Drug Development
- The Altascientist Issue No.41: Immunomodulation Assessments for Clinical Trials: Sophisticated Bioanalytical Approaches to Support Complex Modalities
- Case Study: GLP-1 RA: Overcoming Known Pharmacological Effects
- Case Study: GLP-1 RA: Rapid Clinical Phase I Study Execution
- Blog: 4 Essential Topics to Cover in Your First CRO Meeting
- Press Releases: View More
[On-Demand Webinar] The Future of GLP-1 Drugs
As GLP-1 drugs reshape the market, understanding their potential risks, applications, and economic effects is crucial for professionals in the pharmaceutical and healthcare industries.
Join Altasciences’ webinar to discover future trends and potential breakthroughs.
Speak with one of our experts to discuss your drug development program.
You may also be interested in these resources
- Scientific Journals: Managing the Complexities of GLP-1 Drug Development
- Fact Sheet: Metabolic Disorders Clinical Trials
- Case Study: Randomized Cross Over Efficacy Study Metabolic Disorder
Altasciences’ Commitment to Bioanalytical Excellence
Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services
We have been your trusted drug development research partner for over 30 years. We are committed to providing world-class bioanalytical services in support of the preclinical and clinical studies conducted at our cutting-edge facilities, as well as extensive standalone solutions to meet your diverse needs. Our flexible bioanalytical services from discovery to Phase IV empower our clients across every phase of research.
We recently launched the Unveiling the Invisible video campaign to showcase how our bioanalytical solutions provide critical insights that unveil the invisible and drive the creation of your innovative therapies.
RELATED RESOURCES
Our bioanalytical team excels in comprehensive bioanalytical services, including assay and method development, molecular biology, mass spectrometry, ligand binding assays, immunogenicity testing, biomarker analysis, flow cytometry services, and more, to support your journey from discovery through Phase IV.
Below are some resources that highlight our extensive knowledge, and wealth of bioanalytical experience.
- The Altascientist Issue 41: Immunomodulation Assessments for Clinical Trials—Sophisticated Bioanalytical Approaches to Support Complex Modalities
- eBook: Key Considerations for Nonclinical AAV Gene Therapy Development
- eBook: Key Biomarkers of Immunomodulation
- Scientific Research Article: A Novel Hybridization LC-MS/MS Methodology for Quantification of siRNA
- Scientific Research Article: A Validated Capillary Microsampling LC-MS Method for Quantification of ASOs in Mouse Serum
- Scientific Research Article: Microsampling in Pediatric Studies
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
Discover the Dynamic Landscape of GLP-1 Drug Development
In this issue of The Altascientist, we explore the current and future development of GLP-1 receptor agonists (GLP-1 RAs), and the complexities involved in the early phases.
Topics covered include preclinical models, bioanalytical assays, clinical study design, manufacturing, and the expanding applications of GLP-1 drugs in treating various health conditions. Exclusive case studies are also presented.
Questions about your drug development program? Speak with one of our experts.
Related resources that may interest you:
Sensitive ASO Quantitation for Decentralized Trials
In this poster presentation, our scientific team demonstrates the promising future of blood microsampling in decentralized clinical trials to support the development of antisense therapeutic drugs.
Find out how they achieved precision, accuracy, and linearity within acceptance criteria with our sensitive and selective bioanalytical method for determining ASOs. Covering an analytical range of 0.50 – 500 ng/ml, they used dried blood micro-samples collected via the Capitainer® qDBS (10 µL), and analyzed them using hybridization LC-MS/MS.
You may also be interested in the following:
- Microsampling: When Small Steps Lead to Big Outcomes
- Coupling Hybridization LC-MS Workflows With Microsampling
- Sparking the Evolution of Microsampling With the Mitra® VAMS® Device