Zetasizer Helix

ZETASIZER HELIX Develop mechanistic insight into protein conformation stability and aggregation

The Zetasizer Helix delivers structural information at the molecular level, providing mechanistic insight into the unfolding processes and formation of aggregates in biopharmaceuticals.

Key benefits  Study samples at formulation concentration  Understand mechanisms of aggregation  “Expertise Optional” data analysis software provides trend results without making expert level decisions  Advance data analysis tools include a full suite of spectroscopic analysis tools, from pre-treatment to multivariate analysis.  Data analysis modes, isothermal incubation, thermal ramp, and sample series, provide insights into product stability.  In-depth analysis of secondary and tertiary protein structure  Low volume measurements (20μl)

The market-leading Zetasizer dynamic light scattering platform is coupled with Raman spectroscopy for protein size and structural determination. Together, these two measurements provide unique insights into colloidal and conformation stability of biopharmaceutical products. The data derived is an effective tool to develop product understanding, necessary in implementing a Quality by Design strategy. Ultimately, the ability to probe the mechanisms, not just the results, of product agglomeration can be used to improve biopharmaceutical formulations. Based on the Zetasizer Nano ZSP, the system retains a suite of protein characterization capabilities, while adding a new dimension of analysis by coupling with Raman spectroscopy. A Forced Degradation Study: The Reversibility of Thermal Induced Lysozyme Denaturation  30 mg/mL lysozyme in pH 4 citrate phosphate buffer  Monitored size (DLS) and 2° and 3° structural markers (Raman) changes during thermal ramp experiment  Bidirectional ramp results indicates partial unfolding and conformational changes are reversible.

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©2015 Malvern Instruments Limited MRK2127-02

 DLS data: Small size change  Raman data: 2° and 3° structure change  Combined data: Partial unfolding event Specifications

DLS light source

He-Ne Laser 633nm, Max 10mW

Raman light source

Diode Laser 785nm, Max 280mW at the sample

Dimensions (W, D, H)

320 x 600 x 375mm (Zetasizer) 580 x 450 x 200mm (Raman)

Weight

19Kg (Zetasizer) 28Kg (Raman)

150cm -1 to 1850cm -1 6cm -1 resolution

Spectral performance

Backbone - amount of α -helix, β -sheet, and random coil Tyrosine - hydrogen bonding extent, hydrophilic or hydrophobic environment Tryptophan – indole ring dihedral angle to backbone, extent of cation π interaction, if indole ring is buried or exposed, hydrophilic or hydrophobic environment Disulfide – Differentiate conformers, loss of covalent bond

Protein secondary and tertiary structural markers

Data collection modes

Isothermal incubation, Temperature ramp, Temperature jump, Sample / formulation series

© Malvern Instruments Ltd 2015 Malvern Instruments is part of Spectris plc, the Precision Instrumentation and Controls Company. Spectris and the Spectris logo are Trade Marks of Spectris plc.

Malvern Instruments Limited Grovewood Road, Malvern, Worcestershire, UK, WR14 1XZ

Tel +44 1684 892456 Fax +44 1684 892789 www.malvern.com

All information supplied within is correct at time of publication. Malvern Instruments pursues a policy of continual improvement due to technical development. We therefore reserve the right to deviate from information, descriptions, and specifications in this publication without notice. Malvern Instruments shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this material. Malvern and the ‘hills’ logo are International Trade Marks owned by Malvern Instruments Ltd.

Malvern Instruments Worldwide Sales and service centers in over 65 countries; for details visit: www.malvern.com/contact

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Zetasizer Helix brochure - MRK2127-02