Advancing analytical testing and instrumentation for biopharmaceuticals - Pharmaceutical Technology

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Advancing analytical testing and instrumentation for biopharmaceuticals
Instrument manufacturers and testing service providers are offering improved tools to biologic charaterization.


Pharmaceutical Technology
Volume 37, Issue 3, pp. 42


Chad Baker/Getty Images
As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.

In December 2012, Sartorius Stedim Biotech (SSB) expanded its process analytical technology software capabilities by partnering with Umetrics, a provider of multivariate technology, including software for design of experiments (DoE) and multivariate data analysis (MVA). Under the pact, SSB assumes global marketing and distribution of the Umetrics portfolio for the pharmaceutical and biopharmaceutical industries and will integrate Umetrics software programs as private-label products into its own bioprocess portfolio and market these as stand-alone solutions under a dual branding arrangement. The major areas for these software systems are critical process steps, such as cell-culture processes or specific purification steps. MVA enables process parameters to be added in batch trajectories, and DoE software permits these critical process parameters to be identified and quantified.

In January 2013, Waters expanded its biopharmaceutical platform solutions with UNIFI, new ACQUITY ultra-performance liquid chromatography (UPLC) CSH130 C18 and XSelect HPLC CSH130 C18 columns for peptide mapping, and three GlycoWorks kits for glycan labeling and sample preparation. These products further progress routine biotherapeutic analysis, particularly for glycoproteins that require analysis of glycan modifications as well as protein- and peptide-level structural analysis. The biopharmaceutical platform solution brings together UPLC/mass spectrometry (MS) characterization technology with the UNIFI Scientific Information System that was first developed for intact protein mass analysis, peptide mapping, and supporting general bioseparations. The expansion supports a mix of quadrupole time-of-flight (Q-TOF) MS and optical-detection instruments within a networked laboratory workgroup. The newly released Glycan application workflow expands the platform's capabilities to support routine assignment and profiling of released glycans using fluorescence detection. The combination of high-performance UPLC HILIC (hydrophilic interaction liquid chromatography) separations, the company's calibration standards and reagents, and access to Ireland's National Institute for Bioprocessing Research and Training (NIBRT)/Waters' GlycoBase 3+ UPLC glycan unit reference database enables glycan assignments, quantification, and profiling. Developed by Prof. Pauline Rudd's research team at NIBRT, the GlycoBase 3+ database is a repository of glycan chromatographic retention data, expressed in glucose calibration units, and which encompasses sets of glycan structures associated with biotherapeutic glycoproteins.

Also in January 2013, PerkinElmer launched the JANUS BioTx Pro automated workstation for improved process development of proteins. The workstation is designed for high-throughput, small-scale protein purification (of g to mg proteins) and accommodates multiple chromatography modes (column, tip and batch). It supports commercially available plate and column-based screening tools, such as GE PreDictor plates, PhyNexus PhyTip columns, and Atoll columns. Applications for the workstation include resin-binding studies and conditions screening.


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