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SERVICES
Laboratory & Assurance Solutions
INTERTEK PHARMACEUTICAL SERVICES
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Achieving Total Quality You can rely on our global network of experts,
laboratories and specialists to deliver support
Assurance
We have delivered flexible Our scientists, regulatory experts and auditors
including analysis, bioanalysis, formulation
development, biologics characterization,
contract services to the work with you at every stage of development specialist inhalation development expertise,
and manufacturing, providing responsive,
global pharmaceutical quality compliant solutions.
regulatory consultancy, risk assessment,
auditing and supply chain management
industry for over 25 years At Intertek, our wealth of experience and solutions.
depth of industry knowledge enables
our clients to navigate the challenges
of new product development, scale up,
manufacturing and market release whilst
minimising risks and meeting regulatory
criteria accurately. We respond precisely to
your needs with solutions that go beyond
just “testing” to help you achieve total quality
assurance.
Laboratory Services Assurance Solutions
ASSURANCE SOLUTIONS
Toxicology and Impurity Risk Assessment Consulting
Product Development Strategies
Regulatory Affairs
CMC Support & Guidance
Toxicology Consultancy
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INTERTEK PHARMACEUTICAL SERVICES
Bioanalytical Services
With over 20 years of experience conducting regulatory bioanalysis studies, we deliver
FDA/EMA compliant bioanalytical solutions that optimise value for your development
programs
Bioanalysis plays a critical role in the Unique bioanalytical expertise
assessment of drug safety and efficacy Our teams are adept in method development,
and we understand that each project will method validation and transfer of efficient We apply our bioanalytical
present its own unique challenges. Applying and accurate methods which are optimized
our 20 years of experience in conducting for your compound. Projects are assigned expertise and industry
regulatory bioanalytical studies, our teams
work closely with you to ensure that the
to and managed by experienced Principal
Investigators with support from teams of
insight to design strategic
best possible solutions are delivered. Project Managers, Project Coordinators, Senior and efficient bioanalytical
Scientists and Chemists. We provide:
To help you to make informed decisions
faster, our Good Laboratory Practice • Bioanalysis for Large and Small Molecules
programs
(GLP) and Good Clinical Practice (GCP) • Immunogenicity & Neutralizing Antibody
compliant laboratories provide clinical Assays
kit preparation, sample handling and
• Antibody Drug Conjugate (ADC) LC-MS
management capabilities, fully integrated
and Immunochemistry Services
with automated data capture and reporting
systems using the latest bioanalytical • Long History of Bioanalytical Support for
platforms. Biosimilar Drug Development
Our bioanalytical experts have developed • Post Marketing Antidrug Antibody (ADA)
methods for thousands of different assays
compounds, providing phase-appropriate, • Demonstrated Expertise in Ocular Tissue
small molecule and large molecule • Clinical Kit Preparation, Sample Handling &
bioanalytical support, high-throughput Management
sample bioanalysis, pharmacokinetic,
toxicokinetic and pharmacodynamic
support, immunogenicity and biomarker
assays.
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INTERTEK PHARMACEUTICAL SERVICES
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INTERTEK PHARMACEUTICAL SERVICES
Chemistry, manufacturing and controls Stability studies raw material characterisation and sourcing,
(CMC) development strategies and Good With a network of ICH stability storage formulation development, scale up, pilot
Manufacturing Practice (GMP) laboratory facilities in the UK, USA and Australia, we batch manufacturing and testing, cleaning
services play a key role in reaching your next offer an extensive capacity and a range of development and validation, GMP batch
milestone. We provide regulatory-driven, conditions including climatic walk-in chambers manufacturing and GMP release testing with
phase-appropriate, CMC laboratory and GMP and cabinets as well as freezer storage. QP release, we offer a one source solution for
analytical services that can help you to Our stability teams provide professionally supplies for use in Phase I and II clinical trials.
identify sources of risk early in development managed cGMP stability programs for even
and provide sufficient information to help you the most complex of dosage forms including Extractables and leachables studies
meet the stringent regulatory requirements orally inhaled and nasal drug products Extractables and leachables studies are
of registration and production. (OINDP), biopharmaceuticals, medical devices conducted in accordance with regional
or vaccines. guidance, GMP PQRI recommendations,
Integrated formulation & analytical and United States Pharmacopeia (USP)
development Elemental impurity analysis and risk requirements. Our experience in method
Our formulation development scientists assessment development for controlled extractables
are experienced across a range of dosage Our elemental impurities experts can help you studies, coupled with our vast knowledge of
forms including orally inhaled and nasal to develop a compliance strategy to achieve leachable compounds, means that we can
drug products (OINDP), oral, solid, liquid and successful implementation of guidance such anticipate and identify potential sources of
transdermal or topical. Strategic integration as ICH Q3D / USP General Chapter <232>, risk. We support a wide range of closure or
of formulation development with analytics ‘Elemental Impurities – Limits’. Our teams delivery systems such as pre-filled syringes,
ensures a detailed understanding of the design tailored analytical programs involving parenteral products, OINDP and bioprocessing
pharmaceutical materials, their compatibility, both screening studies and toxicological equipment. We conduct glass delamination
physical properties and stability. risk assessment of the data if required. and extractables studies for glass packaging.
Additionally, we can develop and validate Scientific support is available at every stage
methods tailored to your specific products. of the testing program, including toxicological
risk assessment of identified extractables /
leachables.
Clinical trial supplies manufacturing
services
Our clinical trial supplies manufacturing
services are delivered from our state-of-
the-art GMP compliant facility supporting
investigational medicinal product (IMP)
or investigational new drugs for clinical
trials around the world. Integrated with
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INTERTEK PHARMACEUTICAL SERVICES
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INTERTEK PHARMACEUTICAL SERVICES
Biopharmaceutical Services
In an era where financial prudence is a necessity, getting your analytical or
bioanalytical strategy right the first time is more important than ever
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INTERTEK PHARMACEUTICAL SERVICES
Structural Characterisation
Amino Acid Sequencing/ Sequencing studies and peptide mapping using a broad range of enzymatic or chemical digestion followed by Mass Spectrometry
Peptide Mapping: (LC-MS/MS or MALDI-TOF MS).
Terminal amino acid sequence: Confirmation of N- and C-terminal sequences and evaluation of modifications and / or heterogeneity.
Assessment of the degree and positions of both expected and mis-matched disulphide bridges by extended LC-MS/MS study and
Disulphide bridge mapping:
colorimetric test for free sulfhydryl groups.
Glycosylation studies typically including levels of monosaccharides and sialic acid, N/O linked glycan profiling (NPLC, HILIC, IEX or
Carbohydrate structure:
CE-LIF), enzymatic digest and MALDI –TOF or LC-MS/MS.
Physico-chemical Properties
Molecular weight of intact proteins by MALDI-MS, ESI-MS and LC-MS supported by orthogonal techniques such as MALLS,
Molecular weight:
and SDS-PAGE.
Isoform pattern: Isoform and impurity studies using PAGE, SDS-PAGE, IEF, CE, HPLC.
LC patterns: For ID, homogeneity, purity – HPLC, UPLC, SEC, RP HPLC, IEX, AEX.
Electrophoretic patterns: CE(CZE), cIEF, CGE, cSDS, SDS and NATIVE PAGE, Western Blot.
Aggregation studies: SEC (MALLS), DLS, Western Blot, CE, Gel Electrophoresis, SEM/TEM.
Process Impurities: Residual host cell DNA by qPCR, Residuals (such as antibiotics, antifoaming agents).
Potency Assays
To support characterisation, stability, comparability testing and product release, for example, Complement-dependent cytotoxicity
Cell-based Assays:
(CDC), Antibody–dependent cell cytotoxicity (ADCC) and Neutralisation and Proliferation Assays.
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INTERTEK PHARMACEUTICAL SERVICES
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INTERTEK PHARMACEUTICAL SERVICES
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Americas Europe Asia / Australasia
USA +1 800 967 5352 UK +44 161 721 5247 India +91 9819117214
Canada +1 905 542 2900 +44 1763 261648 +91 7045312819
Switzerland +41 61 686 4800 China +86 21 6073 7735
France +33 2 32 09 36 36 Australia +61 3 9316 4600
intertek.com/pharmaceutical