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.
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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 µg 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.