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: enquiries@rssl.com 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: enquiries@rssl.com 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