Overview

4 Advanced Particle Platforms

All four of the Biozen particle platforms were individually designed and built by Phenomenex to take advantage of integral levels of performance, ruggedness, and reproducibility for protein characterization applications. Individually, each platform differs in the proprietary processing techniques used to control particle size and morphology.

15 Particle Chemistries

Workflow

Oligonucleotide Analysis

The Biozen Oligo LC column brings a unique combination of improved chromatographic efficiency from its core-shell morphology and high pH stability necessary for oligonucleotide characterization. Biozen Oligo is packed in a unique bio-inert titanium hardware developed to mitigate non-specific interactions that lead to analyte loss, distortions in peak shape and carry over. Confidently maximize resolution and reproducibility throughout the most demanding of method extremes with Biozen Oligo.

LC-MS Analysis of siRNA using BioTi UHPLC Hardware

Bio-inert hardware gives clear separation of the sense and anti-sense strand. View application.

vs

LC-MS Analysis of siRNA using Stainless Steel UHPLC Hardware

Non-specific interactions were observed using stainless steel hardware resulting in bimodal peak for late eluting anti-sense strand.

Peptide Mapping

Digested mAbs or ADCs typically include a large body of compounds which are crucial to understanding post translation modifications. So we designed two Biozen Peptide columns to offer uniquely different selectivity profiles for these types of bioseparations. Each allows for fast and effective elution windows by utilizing either high efficiency core-shell or thermally modified fully porous particles to gain sharper peaks, better peak capacities, and overall higher sensitivity.

Trastuzumab Biosimilar Peptide Map

Infliximab Biosimilar Peptide Map

With protein aggregate often at very low levels (<0.1% by peak area compared to monomer) and fragment separation a requirement, adequate resolution and peak shape have become even more crucial method outcomes. To address this need, the robust set of Biozen SEC columns were developed with a combination of UHPLC efficiency and higher sensitivity, to drive resolution and identification of even lower level targets.
View Biozen dSEC-7 Brochure
View Biozen dSEC-2 Brochure

Sample

1. AAV2-CAG-GFP, 2E13 vg/mL
2. AAV5-CMV-GFP, 2E13 vg/mL
3. AAV8-CMV-GFP, 2E13 vg/mL
4. AAV9-CMV-GFP, 2E13 vg/mL

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Biozen WCX was crafted to consistently decipher between native protein variants that arise from PTMs within a therapeutics creation and development. The linear polycarboxylate chains grafted to monosized non porous polymeric particles, envelop and separate proteins from acidic and basic protein variants. With such a highly tuned and controlled manufacturing process, Biozen WCX HPLC columns affords scientists a way to reproducibly characterize heterogeneity while taking advantage of excellent recovery through high particle inertness and bioinert titanium BioTi™ column hardware. View Application Note.

Sample:
Trastuzumab

Impurity profiling and characterization of intact biologics and fragments is a challenging undertaking because of the need to identify very small differences between variants. Both Biozen Intact columns. contain skillfully manufactured large pore core-shell particles that provide narrower, taller peaks in conjunction with higher resolution between the target mAb HC/LC, Fc/Fab, or isoforms.

Sample:
Trastuzumab

Sample:
Infliximab F(ab)₂

Sample:
Cetuximab

Intact mass can give indications not only of relative abundance of glycoforms , but also stability as degraded mAbs will not give good charge envelope by ESI-MS. Intact Mass with a high resolution MS to identify PTMs, especially relative abundance of glycoforms , combines extremely well with the fast run times and tight peak shapes provided by the Biozen Intact XB-C8 and Biozen WidePore C4.

Sample:
Trastuzumab

With a direct effect on efficacy and safety, conjugation for each ADC must be well understood. The Biozen Intact XB-C8 provides an excellent vehicle for determining drug load distribution and DAR for ADCs. Its large pore size allows intact ADCs to interact with a moderately retentive stationary phase while the core-shell particle supplies increased efficiency to deliver the required resolution between ADC species with differing drug loads.

When quantitating signature peptides from biological matrices, you need sharp peak shape and sufficient retention of hydrophilic peptides to prevent any signal loss from matrix suppression regions. Both Biozen Peptide columns were developed to deliver excellent selectivity for even closely related peptides. Additionally, they build on this body of valuable characteristics with unique ways of delivering sharper peak shape for basic peptides; Biozen Peptide XB-C18 blocks secondary surface interactions via isobutyl side chains, while the Biozen Peptide PS-C18 contains a positively charged weak base that repels other basic species.

Sample:
As noted

The unique selectivity of the Biozen Glycan was designed to provide higher order separations of released and labeled glycans. With a 2.6 μm core-shell particle size, customers using either HPLC or UHPLC systems can draw upon a high efficiency Biozen Glycan particle run at higher linear velocities to easily provide sharper peak shapes and faster elution windows, without high UHPLC pressures. Under HILIC-FLR or HILIC-MS conditions, the Biozen Glycan excels with increased polar retention and selectivity.

Sample:
As noted