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 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.
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.
COVID-19 VACCINE AND THERAPEUTIC TESTING AND DEVELOPMENT SUPPORT
NEW: Immediate Question? ASK OUR EXPERTS NOW
FACTSHEET: COVID-19 Vaccine and Therapeutic Testing and Development Outsourcing Solutions
ARTICLE: Repurposing Vaccines for Intranasal Development
WEBINAR: Quality Control Strategy for Vaccine Development
WEBINAR: Repurposing Products for Inhaled Delivery - Rapid Response Strategies
WHITE PAPER: Best Practice for Pharma Remote Audits
ARTICLE: Biomarker Development & Validation
WHITE PAPER: Strategic Partnerships with Contract Laboratory Organisations
WHITE PAPER: Mitigating Risks in Pharmaceutical Batch Release
WEBINAR: A Hi-Res Accurate Mass Spectrometry Validated Method for Nitrosamine Analysis
WEBINAR: Optimising Protein Impurity Analysis for AAV Capsids
REPORT:Peptide Therapeutics, Designing a Strategic QC Program
ARTICLE:Biophysical Characterisation of Biosimilars
WEBINAR: Glycosylation Site Specific Approaches for Antibody Therapies
WEBINAR: QC Strategy for Vaccine Development
eBOOK: Contingency Outsourcing Solutions
Access our comprehensive Digital Resource Library
Biopharmaceutical Services Webinar Programs
Register now for webinars on these topics:
Immunogenicity testing
Comparability for biosimilar antibodies
PK and immunogenicity assays for biosimilars
Regulatory considerations for antibodies
Potency testing for biosimilars
ARTICLES
New Approaches to Bioassay Design
Characterisation of Bispecifics
The Significance and Challenges of Inhaled and Nasal Biologics
Monoclonal Antibody Characterisation - Addressing CQAs
Current Analytical Approaches to Biophysical Characterisation
Biosimilar Characterisation and Immunogenicity
WHITEPAPER DOWNLOADS
GMP Flow Cytometry: Applications, Considerations and Challenges
Liposome Physicochemical Property Analysis
Formulation of Biologics for Inhaled and Nasal Delivery
The Complexities of Antibody Drug Conjugate Characterization
BROCHURES
Download: Intertek Biopharmaceutical Services Brochure
Download: Intertek Pharmaceutical Services
Intertek Pharmaceutical Services Manchester
P.O. Box 42
Hexagon Tower
Blackley
Manchester, M9 8ZS
United Kingdom
For location use: M9 8GQ