Bioanalysis by Hybridization ELISA for Antisense Oligonucleotides
How hybridization ELISA can be an effective approach to quantify antisense oligonucleotides in circulation and in their targeted tissue.
- The advantages and limitations of hybridization ELISA
- The different types of hybridization ELISAs and how to choose the right format
- The possible platforms to use for hybridization ELISA
- The common bioanalytical issues encountered and mitigation plans
- The most common challenges encountered with different matrices and tissues
ISSUE NO. 12 — Antisense Oligonucleotides
Antisense oligonucleotides—or ASOs—are short, synthetic, single-stranded oligonucleotides extensively used for altering RNA expression to reduce, restore, or modify protein expression via several distinct mechanisms. With possible applications extending to both neurological and non-neurological conditions, there is great potential for valuable new therapeutics.
Developing robust bioanalytical assays is essential for accurately quantifying ASOs within intricate biological matrices, including eye, liver, or brain tissues, and these assays must exhibit high sensitivity to detect ASOs at low concentrations while simultaneously being immune to interference from other components in the sample. Hybridization-based assays have emerged as reliable and effective methods for precisely quantifying ASOs both in circulation and within targeted tissues.
In Issue 12 of The Altascientist, we explore advances in hybridization-based assays more deeply, in addition to:
- regulatory considerations
- case studies
- bioanalytical considerations, including:
- ADAs and metabolite interference
- ASO quantitation in tissues
- method sensitivity
- ADAs and metabolite interference
This issue also features two case studies about resolving challenges with matrix effect and about stability of ASOs in tissue matrix.
Analysis of Fenfluramine and Norfenfluramine in Mouse Brain and Cerebellum by Liquid Chromatography Tandem Mass Spectrometry using a Novel Solid-Supported Liquid Extraction
Altasciences Adds Comprehensive Contract Manufacturing and Analytical Services to its Early Phase Research Offering
Laval, Quebec, February 27, 2020 – Altasciences, a mid-size CRO specializing in a flexible, innovative approach to providing comprehensive early stage drug development from lead candidate selection to proof of concept, today announced that it has acquired Alliance Contract Pharma. This acquisition adds small molecule contract manufacturing and analytical services from API to commercialization, including commercial manufacturing, GMP warehouse storage, and clinical supply distribution, to Altasciences’ full-service preclinical, clinical, and bioanalytical offerings.
Transferring data, projects, and/or methodologies between CROs, or between different groups within a multi-service CRO, takes time, is prone to error, and can lead to prolonged R&D timelines. Altasciences is addressing these challenges through the integration of key strategic additions, such as their preclinical business in October 2018, and now Alliance Contract Pharma. Clients partnering with Altasciences on their drug development programs benefit from working with a fully integrated CRO, allowing for quicker, more proactive development timeline adjustments and decision making to improve R&D efficiency.
“The addition of Alliance Contract Pharma continues to fulfill our strategy of creating a comprehensive offering that facilitates the outsourcing experience for our clients. We remain committed to providing our clients with value-added services that create a new paradigm of drug development outsourcing,” added Chris Perkin, CEO of Altasciences.
“We are excited to be joining a team that is responsive and understanding, and continuously looking to create innovative partnerships that redefine the status quo and address the challenges that our clients face in meeting critical milestones,” stated Stephen Schweibenz, President of Alliance Contract Pharma.
BlackArch Partners served as exclusive financial advisor to Alliance Contract Pharma.
CONTACT:
Julie-Ann Cabana
514 601-9763
jcabana@altasciences.com
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization 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, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Making the Most of your CRO Partnership
Partnership
Choosing the right CRO as a partner for your drug development programs is a vitally important step to achieving critical decision making