Vaccine Characterization, Analysis and Bioanalytical Support

GLP, GCP and GMP vaccine characterisation and bioanalytical support for vaccine developers and manufacturers including stability studies and release testing

Globally a wide range of candidate vaccines are under development with the aim of protecting against life-threatening diseases. These are based on a wide range of technologies including viral vector based products, lipid nanoparticle encapsulated mRNA, protein antigen or carbohydrate based products. 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 or specialist analysis to help trouble shoot a process through to a full characterisation or batch release package, our laboratories in the USA, 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.

Characterisation Supporting Development
These products can present challenges for characterisation and development. 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 in response to vaccine administration. Intertek are experts in assay development and validation to ensure bespoke methods are robust to meet the requirements of preclinical and clinical analysis. Intertek’s scientists support the characterisation of the humoral and cellular immune response to vaccines, assessing functional antibody, cytokines and T cell responses. Patient selection through the evaluation of pre-existing immunity and comparison of the magnitude and duration of the immune response comparing pre-vaccination and post vaccination samples. If the immune correlate of protection has been established immunological methods can be performed to confirm the vaccines efficacy. Our USA bioanalysis laboratory provides small batch size custom kits for sample collection to meet your clinical study needs. We offer specific kit manufacture and design, depending on route of administration i.e. nasal swabs for intra-nasal dosing. A wide variety of sterile fill options are also available including protein inhibitors for more specialized blood collections.

Inhaled or Intra-nasal Vaccine Development
There has been increased interest in immunisation via inhaled or nasal administration and delivering vaccines via oral or intra-nasal routes. There are already marketed inhaled vaccine products such as vaccinations for 'flu. 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.

 

GMP and CMC Laboratory Services Outsourcing
Our global network of laboratories offer a comprehensive range of GMP analytical services to support product development including extractables and leachables, stability studies, elemental impurity analysis and more. We can offer a range of flexible contracts that can help meet your needs when your existing testing capacity is stretched. Bringing quality and safety to life, we offer Total Quality Assurance expertise, helping you to navigate the challenges of development, regulatory submission and production.