Analytical services
With more than 20 years of scientific expertise and an extensive state-of-the art GLP & GMP analytical platforms, Bertin Pharma provides method development, Quality Control
and stability testing
within a full development project or as stand-alone service.
Whatever your need is, from stand alone services to full development program, Bertin Pharma provides tailored-made solutions including:
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Analytical Development & Validation
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Transfer and optimisation of analytical methods
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Method development and adaptation throughout the formulation development
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Validation, carried out following international standards and guidelines (ICH)
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Quality control (EP, USP or Internal monograph)
Bertin Pharma provides the following services:
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Methods validation according to ICH and SFSTP guidelines
(clinical dose formulation) and according to the white paper entitled
"NonClinical Dose Formulation Analysis Method Validation and Sample Analysis
" released in
AAPS J
.
2010 Aug 14 (nonclinical dose formulation)
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Methods evaluation and optimization
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Cleaning validation
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Evaluation and updating of Marketing Authorization files
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Shelf-life determination
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Validation and stability reports
In the early stages of formulation development, assessment of sensitivity of the drug substance to acid, base, oxidation, light, moisture must be performed.
Bertin Pharma is opened to stability studies as stand-alone services for companies looking for sub-contracting part, or all their stability studies.
For your biologics, we offer a comprehensive expertise based on customised analytic programs in order to develop and validate specific methods and to resolve key issues along the drug development process. See here additional information.
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API Development
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Finished Product Development
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Batch Release (QC Controls, stability, pilot)
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Control of clinical
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Purity and titer
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Size and charge
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Primary, secondary and tertiary structure
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Aggregates, oligomers, non-covalent complex
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Impurities
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Glycosilation sites, pattern/sequencing
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Biological activities and binding
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Immunogenicity
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Related services
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Protein & HCP analysis
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Preformulation & formulation
- Industrial transfer
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Manufacturing & packaging
- Quality control & dispatch of clinical supplies
- Clinical supplies chain
- Regulatory affairs
