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Altasciences Expands Ligand Binding Laboratory to Meet High Demand for Bioanalytical Solutions
Laval, Quebec, November 23, 2021 — Altasciences, a leading drug development solution company, announced today the completion of a second expansion of their ligand binding laboratory to meet the high demand for quality bioanalytical services. The GLP, GCP laboratory was enlarged to include 52 benches for sample analysis, an enhanced space for cell culture and flow cytometry services, additional extraction rooms for handling all types of tissue matrices, a dedicated CL2 room for handling samples and RG2 material, a balance room for critical reagent and solution preparation, and an extraction space for an additional 50 analysts.
“At Altasciences’ One Laboratory Sciences, we accelerate our clients’ programs by seamlessly integrating our new state-of-the-art bioanalytical lab with our preclinical and clinical studies,” added Dr. Lynne Le Sauteur, Vice President, Laboratory Sciences.
With this expansion, Altasciences’ ligand binding assay tripled its square footage and will add to its employee base. Altasciences’ goal is to offer clients the opportunity to leverage the significant knowledge and industry experience of our team of scientific experts to develop strategic bioanalytical testing plans to complement their drug development programs.
“Our growing state-of-the-art laboratory will further expand our breadth of expertise and services for ligand binding assays, cell-based assays, flow cytometry, and other specialty assays to support biologics and oligonucleotide drug development,” says Dr. Danielle Salha, Senior Director, Immunochemistry & Immunology, Ligand Binding Assays.
Altasciences uses innovative and cost-effective approaches to develop or customize ligand binding assays for the quantitative determination of biologics and small-molecule therapeutic products. Altasciences continues to expand its immunogenicity, PK, oligonucleotide, and biomarker testing to its already robust preclinical and clinical study and bioanalysis testing capabilities.
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, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
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ISSUE NO. 20 — Validation of Immunogenicity Assays
Regulatory guidelines focusing on immunogenicity assays for clinical studies are not all applicable to nonclinical requirements and their unique challenges. While we have a full understanding of regulatory requirements for clinical studies, the lack of regulatory documents addressing the particular needs of nonclinical immunogenicity studies has contributed to less consensus on appropriate immunogenicity testing strategies and validation parameters. This, by extension, has led to different approaches being adopted by the drug development industry.
In Issue 20 of The Altascientist, we review and share some of Altasciences’ approaches to validating immunogenicity assays for nonclinical and clinical studies, including insight on:
- how to plan for immunogenicity assessments
- drug tolerance
- positive control
- managing variability
- critical reagent validation and changes
- neutralizing anti-drug antibodies (NAbs)
Immunogenicity Assays in Nonclinical and Clinical Studies: Goals and Challenges
Nonclinical and clinical immunogenicity assessments each have their own challenges. For instance, achieving the appropriate level of drug tolerance in nonclinical studies may be difficult, and availability of critical reagents in the early stages of nonclinical studies versus a long-term supply to support clinical phases of the drug development program may present a challenge.
Clinical immunogenicity assessment aims to ensure patient safety, and provide the required information to support efficacy results by characterizing the immune response generated against the drug in terms of quality and quantity.
The purpose of nonclinical immunogenicity assessment of drugs destined for human use is primarily to support the understanding of toxicokinetic data. In nonclinical studies, the drug may be foreign to the host as the biotherapeutics are developed to mimic human molecules, and they may be administered at much higher doses than will be given to humans. Consequently, the immune response generated in nonclinical studies is often expected and must be interpreted with caution.
Sensitivity of the ADA method is sometimes an issue in clinical studies, especially when working with complex matrices such as those from oncology disease-type populations. Clinical studies also require additional levels of characterization of the immune responses, and the development of cell-based neutralizing antibody assays and domain binding specificity determinations, both of which can be complex and challenging, may be necessary.
Immunogenicity assays have to adapt as the drug development program progresses. Nonclinical assays may be qualified or validated with few requirements. However, immunogenicity assays used to support clinical studies must be validated with well-defined, regulation-compliant requirements.
How Altasciences Can Provide Assay Validation for Your Nonclinical and Clinical Studies
Altasciences’ deep knowledge of fit-for-purpose nonclinical and clinical immunogenicity assessment allows efficacious acceleration of drug development. We routinely tailor assay development and undertake a validation that supports the 3R principle of reduction, while saving time and resources.
We have nonclinical and early-phase clinical expertise, with integrated solutions to ensure that, as your drug development program accelerates from nonclinical to clinical phases, we achieve efficiencies through adaptation of the nonclinical ADA method to human serum. This is achieved by minimally changing the matrix, whenever possible, extensively assessing the appropriate parameters required for the clinical study, such as sensitivity, specificity, cut-points, and selectivity in normal or disease matrix, and adjusting the assay accordingly. The same critical reagents are ideally secured in large amounts in order to maintain assay reproducibility throughout the clinical study and are re-qualified in the new assay format.
Our nonclinical and clinical scientific experts work closely together to maximize efficiencies and share their knowledge and experience to deliver the best possible approaches to your immunogenicity assay requirements.
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