Full Name: Zetasizer Helix
Team: Malvern Instruments
Status: Ready to help users gain a better understanding of biologic formulations
Debut: July 2014
Field Position: Early stage development operations
Skill Set: Raman spectroscopy combined with Zetasizer dynamic light scattering (DLS) technology enables detailed studies of protein aggregation mechanisms.
• Allows measurement of protein size and structure from a single small volume sample.
• Enables monitoring of the changes in secondary and tertiary protein structure.
• Combination of dynamic light scattering with Raman spectroscopy characterizes chemical, structural, and physical parameters of biotherapeutic proteins under formulation conditions - at high concentrations up to 100 mg/ml and using a wide range of buffers and excipients.
Player’s Profile: Guides biopharmaceutical drug development by delivering protein structure assessments to support QbD-based analysis and processing regimes.
Coach’s Notes: "The DLS/Raman spectroscopy combination provides unique insight into protein folding, unfolding, aggregation, agglomeration and oligomerization. Such detailed information supports both the effective application of Quality by Design and the efficient development of biosimilars."
Scout’s Notes: The Zetasizer Helix is the latest commercialized product to emerge from Malvern’s Bioscience Development Initiative (BDI), a collaborative research program dedicated to providing solutions to the evolving needs of the biopharmaceutical industry. A key priority for the industry is obtaining a greater understanding and control over the formulation process, a need exacerbated by the increasing adoption of QbD. By allowing users to fully scope protein behavior within a formulation, the Zetasizer Helix provides insight at the molecular level as to which variables trigger, for example, oligomerization and aggregation, supporting a QbD approach.
Team Resources: Headquartered in Malvern, UK, Malvern Instruments has subsidiaries in all major European markets, North America, Mexico, China, Japan and Korea, and a joint venture in India. Malvern provides the materials and biophysical characterization technology and expertise that enables scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, sprays and aerosols, to industrial bulk powders and high concentration slurries.