Contract Analytical, Bioanalytical and Formulation Development Services
Intertek’s pharmaceutical services provides expert analytical services to support both small molecule and biologic drugs, through a network of laboratories dedicated to helping clients around the world overcome the analytical challenges of drug development and manufacturing. With pharmaceutical scientists and regulatory experts who work with clients at every stage of development, Intertek provides a comprehensive and flexible service geared at establishing a marketplace advantage.
Over the last 20 years, the Intertek network of Good Laboratory Practice (GLP) and Good Manufacturing Practice (cGMP) laboratories has provided high quality technical services for some of the world’s largest and most innovative pharmaceutical companies.
Regulatory-driven, phase-appropriate laboratory CMC support programs include method validation, analysis, stability, extractables / leachables, cGMP quality control and release testing with specialized expertise for biopharmaceuticals, inhaled medicines, and other drug delivery technologies. During preclinical and clinical development, Intertek’s biomarker and bioanalysis experts design and manage strategic work programs.
- Bioanalysis Services
Intertek has over 20 years of experience in conducting regulated bioanalytical studies supporting the development of pharmaceuticals, biopharmaceuticals, vaccines and biosimilars. Expert bioanalysis support for both small molecule drugs and biologics is provided through a global network of GLP-compliant laboratories located in California, US (San Diego) and in the UK (Manchester).
Capabilities include proprietary method development, validation, method transfer, high throughput sample analysis and pharmacokinetic and toxicokinetic support, combined with automated data capture and reporting systems. Clinical sample management services are provided for collection and shipment of samples from clinical study sites.
Large molecule bioanalysis support includes immunoassays, ligand binding assays supporting toxicokinetics (TK) and pharmacokinetics (PK) studies, immunogenicity and biomarker studies. Intertek’s scientists have extensive experience in the development, validation, and quantitative or qualitative GLP immunoassays in support of clinical and preclinical studies and regularly work with clients from all around the world, on a range of product types including monoclonal antibodies, biosimilars antibodies-drug conjugates, growth factors, hormones and cytokines.
Lori Payne, Intertek’s Bioanalytical Business Development Director said “Recognizing the critical role bioanalysis plays in drug development, Intertek’s mission is to consistently deliver accurate and reliable data that is subject to rigorous scientific and regulatory review, ensuring the success of our clients’ discovery, preclinical and clinical programs.”
- GMP Biopharmaceutical Drug Development Support
Intertek recognizes that successful development of a biologic medicine depends on ensuring the safety, efficacy, quality, purity and potency of the biopharmaceutical product.Intertek’s biopharmaceuticalexperts strategically deploy orthogonal analytical approaches that address key molecular and biological characteristics which are relevant to ensuring the safety and efficacy of the product. This includes total protein quantity, the extent of heterogeneity within a sample and across batches, the intricacies of the biomolecule’s structure including post-translational modifications (PTM) and assessment of aggregation. Intertek’s scientists are also adept at developing and validating stability-indicating methods addressing potential decomposition pathways and conducting stability studies.
With a deep understanding of the latest regulatory developments, Intertek ensures that analytical data meets the requirements of Good Manufacturing Practice (GMP), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and OECD GLP regulatory standards where appropriate. Intertek’s have over 20 years’ experience in biopharmaceutical development support across a range of product types including proteins, monoclonal antibodies, vaccines, PEGylated proteins, antibody drug conjugates, peptides, oligonucleotides, glycoproteins and biosimilars.
Ashleigh Wake, Biopharmaceutical Services Leader said “With broad capabilities in North America and Europe, our experts provide strong scientific and technical leadership coupled with project management and regulatory support, to drive your development and manufacturing programs forward.”
Our Biopharmaceutical Expertise
To meet your development milestones and comply with regulatory requirements, you will need high quality bioanalytical and analytical data to aid informed decision-making and identify sources of risk. Safety assessment is key, as slight changes in the structure, physicochemical properties, stability and impurity profile of a biologic can provoke an adverse immune response.
Our thought-leaders have over 25 years
of experience in biopharmaceutical development support across a wide range of product types. We provide regulatory- led, phase-appropriate, tailored analytical program design with GLP / GCP / GMP compliant laboratory services which
help you to navigate the challenges of
development, regulatory submission, and manufacturing.
With facilities located in India, Europe (UK, France, Switzerland) and the USA, our strong scientific and technical leadership coupled with project management and regulatory support, deliver a responsive, flexible (bio)analytical resource, to drive your development and manufacturing
Our biopharmaceutical services
• GLP Clinical & Preclinical Bioanalysis
(PK, ADA, Nab)
• Immunogenicity Studies
• Analytical Programme Design
• Structural Characterisation (ICH Q6B)
• Physicochemical Properties (ICH Q6B)
• Biophysical Characterisation
• Comparability Studies
• Biosimilar Programmes
• Process Residuals Determination
• Product Related Impurities Determination • Purity and Impurity Assessment
• GMP Potency / Cell Based Assays
• Method Development & Validation
• Extractables / Leachables
• GMP Quality Control Testing
• GMP Batch & Final Product Release
• ICH Stability Studies
• Forced Degradation Studies
• Drug Delivery / OINDP Expertise
• Recombinant Proteins & Glycoproteins • Monoclonal Antibodies
• Antibody-Drug Conjugates
• Biosimilars / Biobetters
• Growth Factors
• Viral Vectors
• Oligonucleotide Therapeutics