Vaccine Development Characterization, Analysis and Bioanalytical Support

Vaccine Development Characterization, Analysis and Bioanalytical Support

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At Intertek our experienced scientists stand ready to conduct GLP, GCP and GMP studies to assist you ever step of the way from bench to consumer. Whether this is bioanalytical support for a clinical trial, formulation and delivery technology development (such as inhaled or nasal spray) or specialist analysis to help trouble shoot a process through to a full characterisation or batch release package, our laboratories in the UK and Switzerland are mobilised to support you in your vaccine development and production. Our scientists regularly work on a wide range of product types including viral vectored products (AAV, Adenovirus, Lentivirus), mRNA, toxins, recombinant and natural antigenic proteins and carbohydrates, so whatever your modality we have the expertise to assist you. Our vaccines development support teams provide a suite of services supporting the analysis of process and batch release samples and stability studies. With the application of a comprehensive suite of methods to evaluate the protein, glycoprotein, DNA, RNA, carbohydrate, lipopolysaccharide, lipid and lipoprotein components of vaccines. We also provide characterisation for vaccine delivery systems such as liposomes and nano-lipid nanoparticles. Bioanalytical Support Intertek are experienced in delivery accurate and efficient bioanalysis services supporting preclinical and clinical studies for vaccines including assessment of specific antibody, biomarker and cell-based assays. Our inhaled and nasal drug development team is experienced in support clients with repurposing existing products for oral or intra-nasal delivery. Our OINDP development team provides formulation development, method development and validation, inhalation product analysis, in vitro bioequivalence studies, comparator studies, device/excipient compatibility studies, Quality by Design (QbD), clinical trials materials manufacturing and product characterisation studies. Link: https://www.intertek.com/pharmaceutical/vaccine/
Intertek213Intertek Pharmaceutical Services – Bringing Quality, Safety and Sustainability to Life. Our bespoke, purpose-built GLP / GCP / GMP laboratories have supported developers and manufacturers for over 30 years by providing bioanalytical studies and advanced characterisation programs. We have worked on multiple studies involving cell or gene therapies, mRNA, plasmid DNA based products, and other advanced modalities. Our facility has been designed to handle recombinant genomic materials for the purposes of research and compliant testing, including specialist facilities for handling Class I and Class II Biological Agents. Intertek’s innovative bio/pharmaceutical services are delivered consistently with precision, pace, and passion, enabling you, our customer, to power ahead safely. Our solutions: • Cell and virus characterisation • Virology assays • Host cell and residual plasmid DNA • Cell-based assays / potency testing • General compendial testing • GMP analysis • GCP/GLP bioanalysis • ICH stability storage and testing • Method development and validation • QC release testing • Advanced delivery technology analytical support Find out more: www.intertek.com/pharmaceutical/biopharmaceuticals/gene-therapy-characterisation Contact us today: +44 (0)116 296 1620 | pharma.services@intertek.com Follow us: www.linkedin.com/showcase/intertek-pharma  ATMP Analytical Development Services & CMC Support Presentation Request | AAV Therapies: Developing Effective Analytical Strategies for In-Depth Empty vs Full Capsid Characterization > Brochure | Cell and Gene Therapies Analytical Development Services >

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