Page 17 - Pharmaceutical M5 Biopharma

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Sponsored Feature  17

Impurities Investigation of protein aggregation and more

Biopharmaceutical products are no different from small molecule pharmaceuticals in that all impurities derived from the raw materials,
manufacturing process, formulation and instability need to be fully investigated and controlled (ICH Q3). However, in addition to conventional
impurities, such as elemental impurities, there are certain issues that require particular attention due to the labile nature of proteins.
With a wide-ranging product portfolio, Shimadzu has a long history of providing solutions to address various impurities to
the pharmaceutical industry.

Investigating Aggregates
Protein aggregates form at an accelerated rate if the sample is kept under improper conditions,
such as temperature change, agitation, pH, surface contact and presence of other impurities.
Formation of aggregates is conventionally monitored by size exclusion chromatography(Page 6).
In addition, Shimadzu offers a number of different solutions for investigating the nature of the
aggregates formed, in order to give researchers insight into how aggregates can be minimized.

Aggregates Sizer

Application News:
Evaluation of Protein
Aggregation Under Various
Stress Conditions Using the
Aggregates Sizer

Time-course distribution of particle size of bovine IgG solutionunder accelerating conditions

Application News: Application News: Peer-reviewed journal article:
Accelerated Testing of Protein Aggregates Sizer Enables Yoneda S, Uchiyama S et al.,
Stability Using the Aggregates Evaluation of Biopharmaceutical J Pharm Sci. 2019 Jan;108(1)
Sizer TC (with Temperature Additives to Inhibit Protein Quantitative Laser Diffraction
Control) Aggregation for Quantification of Protein
Aggregates: Comparison With
Resonant Mass Measurement,
Nanoparticle Tracking Analysis,
Flow Imaging, and Light
Obscuration

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