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Analytical Chemistry, Biologics, Medical Device, Pharmaceuticals

Pacific BioLabs Purchases SciEx TripleTOF 5600 High Resolution Mass Spec System

The SciEx TripleTOF 5600 Mass Spectrometer is known for delivering excellent sensitivity and linear
dynamic range. In highly complex matrices, the TripleTOF 5600 provides high-resolution of low-
abundance analytes which is just what PBL needs when performing PK studies or when monitoring
metabolites. The SciEx TripleTOF also improves PBL Extractable Leachable capabilities and provides PBL
with a platform to conduct proteomic analysis.

Extractable and Leachable Testing for Medical Devices

The SciEx 5600 TripleTOF will enhance extractable and leachable testing at Pacific BioLabs by
providing high resolution data, an increased ability to resolve complex mixtures, improved
sensitivity and minimize detection limits. When working with unknown compounds, which is
often the case in E&L studies, generating high resolution accurate MS and MS/MS spectra is
essential for determining the elemental formula. Further, tentative compound identifications can
be obtained through spectral matching with the ChemSpider Library. PBL performs USP
<661.1>, USP <661.2> and ISO 10993 extractable leachable studies for medical device
materials and container closure systems.

Metabolite and Proteomic Analysis

The increased resolution of the TripleTOF 5600 allows the instrument to distinguish
between closely related metabolites of the parent molecule and detect extremely low
levels of metabolites present in a biological sample.
The breakdown of antibody drug conjugates, peptide catabolism, PK bioanalysis and
biomarker studies can be efficiently conducted using the SciEx 5600 TripleTOF.
Proteomics discovery and characterization of a post-translational modifications are areas in
which the 5600 TripleTOF excel.

Additional TOF/MS 5600 Capabilities

Host cell protein contaminants – During the manufacturing process of biopharmaceuticals, small
amounts of host cell proteins (HCPs) could contaminate the product. HCPs could cause unintended
effects on the patient and therefore the presence of HCPs should be assessed.

Pesticide Screening – The screening is made easy by the SciEx 5600 TripleTOF by searching pesticide
MS/MS spectra libraries.

Protein Post-Translational Modification – Analysis of post-translational modifications can be achieved
through the high resolution MS/MS analysis. Post-translational modifications could affect the
performance of a biotherapeutic and therefore should be considered when releasing product. The
accurate mass information covering a wide dynamic range provided by the TripleTOF 5600 is an
effective instrument when doing this analysis.

Protein Sequence Variant Analysis – The production of biotherapeutics is a biological process which
includes DNA replication, transcription and translation. Each step could generate errors which could
affect the amino acid sequence of the protein product. The SciEx TripleTOF and its associated database
search programs provide the required efficiencies in data generation and analysis when looking for low
levels of amino acid sequence variants.

PBL’s Mass Spec Capabilities

The SciEx 5600 TripleTOF/MS is the newest addition to PBL’s other mass spec units which
includes two LC-MS/MS units, an ICP/MS, a GC/MS and an Agilent 6210 TOF/MS. Please
contact PBL for your mass spec analysis.

Pacific BioLabs