mRNA Characterisation and Analysis

mRNA Characterisation and Analysis
Product Description

Characterization and analysis of mRNA supporting vaccine and therapeutic development, including assessing clinical translation efficiency and immunogenicity. At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug product to help you confidently assess batch to batch manufacture and process repeatability as well as the quality of mRNA produced. We are adept in establishing GMP validated analytical methods including general methods, such as identification, assay, content uniformity, residual solvents and elemental impurities, and compendial methods including appearance, pH, osmolality, particulate matter, container closure integrity, sterility and bacterial endotoxins. Additionally, our experts provide mRNA specific methods including integrity, potency, capping efficiency, residual DNA template, residual dsRNA and delivery system testing. These comprehensive characterisation services provide data to determine protein expression and product purity, which can be directly linked to translation efficiency and immunogenicity.

To learn more, visit our website:

www.intertek.com/pharmaceutical/biopharmaceuticals/mrna-characterisation-and-analysis

Read more Show less

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile
Categories
more categories Show less
Specifications
  • Supplied from
    United Kingdom
More specifications Fewer specifications
Sales Markets
Show more Show less

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile

More Products from Intertek Analytical Services (99)

  • Bispecific Antibody Characterisation

    Product Bispecific Antibody Characterisation

    Characterisation of bispecific antibodies supporting regulatory considerations for therapeutic development. Our scientists offer BsAb characterisation, with a focus on monitoring relevant CQAs. We can help you to demonstrate consistency or comparability of manufactured batches or as release tests for clin...
  • Inhalation Product Analysis and Testing

    Product Inhalation Product Analysis and Testing

    Inhalation product analysis and testing services include particle size and droplet characterization, delivered dose testing, as well as aerodynamic particle size analysis – for pressurized metered-dose inhalers (PMDI), dry powder inhalers (DPI), nebulizers, and soft mist inhalers. Our Good Manufacturin...
  • Nitrosamine Impurity Testing

    Product Nitrosamine Impurity Testing

    Nitrosamine - testing for its impurities: Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) continue to be an area for concern as highlighted by the US FDA and other regulatory authorities. At Intertek we believe flexible solutions are the way forward to overcome technical challenges and ac...
  • Antibody / Monoclonal antibody therapeutics services

    Product Antibody / Monoclonal antibody therapeutics services

    Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, ...
  • Gene Therapy Characterisation and Release Testing

    Product Gene Therapy Characterisation and Release Testing

    Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity a...
  • Clinical Trial Supplies Manufacturing Services

    Product Clinical Trial Supplies Manufacturing Services

    Services for manufacturing clinical trial supplies: To meet your supply needs for investigational medicinal products (IMP) or investigational new drugs (IND) for clinical trials around the world, we provide GMP clinical trial materials manufacturing services. Integrated with raw material testing, ...
  • cGMP Cell-based Bioassays

    Product cGMP Cell-based Bioassays

    Cell-based bioassays that comply with cGMP: Using a variety of techniques, including cell-based assays, ligand and receptor binding assays, and flexible multiple assay approaches – our potency testing experts offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1)...
  • Analytical Research and Development Services

    Product Analytical Research and Development Services

    Services for analytical research and development: As your organization focuses on core business goals, you'll require a partner who has a history of providing consistently high-quality regulated compliance testing. Our team are focused on supporting product development, GMP manufacturing and distributio...
  • Protein Aggregation Analysis and Characterization

    Product Protein Aggregation Analysis and Characterization

    Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel...
  • Genotoxic Impurities ID and Quantification

    Product Genotoxic Impurities ID and Quantification

    Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity l...
  • Elemental Impurity Testing ICH Q3D

    Product Elemental Impurity Testing ICH Q3D

    Testing for elemental impurities ICH Q3D: To successfully implement ICH Q3D requirements, our experts in elemental impurities and toxicology can help you develop a compliance strategy. We can provide screening studies and data to aid risk assessment, if this does not already exist, or develop and valida...
  • Biosimilars Testing Services

    Product Biosimilars Testing Services

    Testing services for biosimilars: Our biosimilar analytical comparability programs provide highly relevant data for early stage characterisation and later stage comparison. These programs evaluate and compare all pertinent features of the biosimilar product and are based on the ICH Q6B. Programs encompa...
show all 99 other products

Intertek Analytical Services resources (2)

  • Boosting in Vitro Testing for Nasal Drug Products

    News Boosting in Vitro Testing for Nasal Drug Products

    In Vitro Test Methods for Nasal Drug Products VIDEO: Learn how our Alberta Idealised Nasal Inlet (AINI) capability can deliver enhanced IVBE studies for generics and support the development of novel intranasal products targeting specific nasal regions 
    14 Sep 2022
  • Brochure - Pharmaceutical Services

    Brochure Brochure - Pharmaceutical Services

    Covering our full breadth of contract laboratory services, auditing and regulatory consultancy expertise, this brochures provides a summary of our global capabilities.
    Visit www.intertek.com/pharmaceutical for more information.