Biopharmaceutical Product Analysis
Ensuring the identification, purity, safety and quality of your
biopharmaceutical product.
ICH Q6B and EMA set out the regulatory guidelines for the
physicochemical and structural characterisation of
biopharmaceuticals, which includes a determination of the
composition, physical properties and primary structure of the
desired product. With the number of biopharmaceutical products due
to go off patent in the next few years, the market for biosimilars
is set to grow significantly. To gain regulatory approval,
significant analytical data is required to confirm that the product
has the appropriate quality, safety, efficacy and comparability to
the originator molecule.
Reading Scientific Services Ltd
The Reading Science Centre, Whiteknights Campus, Pepper Lane,
Reading, Berkshire RG6 6LA
Tel: +44 (0)118 918 4076 Email: [email protected] Web:
www.rssl.com
Additional Product SupportRSSL offers a wide range of services
to help you navigate your biopharmaceutical challenges,
providing analysis to GMP, expert consultancy advice and
training to support you through the
development, production and quality assurance cycle.
RSSL’s Biopharmaceutical ServicesRSSL offers a comprehensive
range of analysis required in ICH Q6B and EMA Guidelines.
We can support you with:
Contact us to find out more about our expertise and how we can
support you:Tel: +44 (0)118 918 4076 Email: [email protected] Web:
www.rssl.com
Reading Scientific Services Ltd
The Reading Science Centre, Whiteknights Campus, Pepper Lane,
Reading, Berkshire RG6 6LA
Process Related Impurities
Host cell DNA and Protein
Cell Culture Impurities
Downstream-derived Impurities
Mycoplasma
Product Related Impurities
Post Translational Modifications
Aggregation Studies
Truncated Forms
Immunochemical Properties
Functionality Assay by ELISA
Western Blot
Physicochemical Properties
Molecular Weight or Size
Isoform Pattern
Extinction Coefficient (or Molar Absorptivity)
Electrophoretic Patterns
Liquid Chromatographic Patterns
Structural Characterisation
Protein or Peptide Sequencing by Peptide Mapping
Sequence Variation
Glycan Analysis
Amino Acid Composition
Terminal Amino Acid Sequence
Sulfhydryl Groups and Disulphide Bridges
Carbohydrate Structure
• Protein Purification
• Extractables and Leachables
• Method Development and Validation
• Microbiology
• Physical and Structural Characterisation
• ICH Stability Storage
• Raw Material and Finished Product Testing
(BP, USP, EP, JP)
• Formulation Support
• Sub-visible Particle Analysis
• Biotechnology Issues Training
• Bioassays for Potency
