Free Vendor Technical Workshops
- Thermo Fisher Scientific
- Waters Corporation
- Thermo Fisher Scientific
- Waters Corporation
- Shimadzu Scientific Instruments
- Agilent Technologies
See Vendor Workshop Descriptions below
Large Molecule Separations – Innovative Chromatographic Solutions from Peptides to RNA
Christof Mitterer, Thermo Fisher Scientific, Langerwehe, GERMANY; Robert van Ling, Thermo Fisher Scientific, Breda, NETHERLANDS
Liquid chromatography is one of the main analysis techniques for the separation and characterization of biomolecules. Though most HPLC columns are based on silica pack-beds, at Thermo Fisher Scientific we have a range of extra-high performance columns available that are specifically designed for complex large molecules. Our unique µPAC™ HPLC columns utilize a separation path filled with tightly controlled, partially porous micro-pillars. This not only allows for extra-high performance separations for digested proteins, but in addition creates a exceptionally reproducible and robust column for low-flow LC-MS. For the analysis of intact protein and antibodies, as well as for the analysis of oligonucleotides, we have a range of polymeric bead-based columns available. These MAbPAC™ RP and DNAPac™ RP columns are much more stable under elevated temperature and pH conditions, offering new possibilities in the optimization of workflows and detection methods. In this workshop, we will discuss the capabilities of these columns. But more importantly, we hope to trickle your imagination, and discuss with us how they can help you overcome your challenges in biomolecule analysis.
Atlantis Premier Columns: A New Column Family Designed to Address the Challenges of Polar Analyte Retention
Jonathan E. Turner, Waters Corporation, Milford, MA, USA
Achieving high retention for polar analytes remains a significant challenge for many separation scientists. Polar acidic analytes are poorly retained due to ionic repulsion caused by deprotonated surface silanols found on traditional reversed-phase (RP) columns. Mixed-mode RP/anion-exchange (AX) stationary phases address this issue, but the existing RP/AX chemistries suffer from poor batch-to-batch reproducibility and limited pH ranges. HILIC is often used and the zwitterionic stationary phases gaining the most popularity due to their retention for a wide range of polar analytes, including neutrals, anions, and cations. Unfortunately, some existing zwitterionic stationary phases suffer from poor batch to batch reproducibility and limited pH stability. To overcome these challenges, we developed two new column chemistries, a mixed mode RP/AX and a zwitterionic HILIC chemistry, both built on high surface area ethylene-bridged hybrid organic/inorganic particles. New MaxPeak™ High Performance Surface column hardware was employed to improve the recovery and peak shape of acidic analytes that bind to metal surfaces. We will discuss the utility of the two stationary phases along with key applications separating several important analyte classes.
The Role of HPLC in mRNA Analysis
Jacob Fairchild, Moderna Therapeutics, Cambridge, MA, USA
The landscape of chemical medicines and biologic entities used for pharmaceutical development is constantly evolving. In the last few years strong momentum for the development and commercialization of nucleotide-based therapeutics, inclusive of oligonucleotides and mRNA, has revolutionized the landscape of therapeutics. In this seminar we will present how the Vanquish LC platform with its unique technology is ideally suited to address the challenges of mRNA analysis. This includes the use of the universal Charged Aerosol Detector (CAD) for characterization of lipid nanoparticles (LNP) components accompanied by the Vanquish Duo system for Dual LC for fast and comprehensive analysis of mRNA and its impurities. The seminar continues with Jacob Fairchild, Ph.D, Senior Scientist at Moderna, describing the potential of mRNA modalities as vaccines and therapeutics. The development of one of the first mRNA vaccines was made successful by understanding the critical quality attributes of mRNA drug products, which enabled effective deployment around the globe. Jacob will focus on the role HPLC analysis played in addressing analytical challenges of mRNA analysis. HPLC and other robust analytical methods coupled with stringent manufacturing controls are necessary to ensure mRNA stability and high activity in LNP delivery systems.
It’s a Losing Game; Solving for Adverse Effects in Separations, One Surface at a Time
Patrick Flanagan, Waters Corporation, Milford, MA, USA
From the plates and vials used throughout sample preparation, eventually containing the final sample for analysis, to the system you use to analyze it, the opportunities for sample loss in a chromatographic workflow are abundant. The presence and magnitude of these losses is inconsistent, leading to reduced repeatability and reproducibility of your analyses, impacting sensitivity for low-level analytes, and challenging your confidence in the results to inform the decisions you need to make. Waters’ MaxPeak Premier Solutions were developed to help solve some of the most complex challenges associated with unpredictable chromatography, by focusing on the surface interactions that contribute to analyte loss and preventing those interactions from occurring, to reduce variability associated with metal-sensitive analytes, to avoid time-consuming tasks like system and column passivation, and increase sensitivity. Fundamentals of the science behind MaxPeak High Performance Surfaces, the incorporation into instrumentation, and the benefits it brings are explored with application examples.
Mass Spec and Chromatographic Solutions from Biopharma Process to Product Development and Quality Control
Mridul Mandal, Nivesh Mittal, Shimadzu Scientific Instruments, Inc., Columbia, MD, USA
Analytical development of biotherapies has widely relied on liquid chromatography (LC) and mass spectrometry. Nevertheless, its implementation in GMP-compliant commercial quality control (QC) laboratories remains challenging. The current study describes the latest developments in liquid chromatography and mass spectrometry (LC-MS and MALDI) technologies that can be used to monitor biologics for commercial product release and stability testing using automated, high-throughput, and GMP compliant methods. Among these are the newly developed Bioinert UHPLC system, triple quad LC-MS with ultra-sensitive polarity switching, QTOF, an automated sample preparation system, and in-house and collaborator informatics to support complex biologic analyses. The Intelligent Peak Deconvolution (i-PDeA) and the Analytical Quality by Design (AQbD) approaches assist with the analysis of biomolecules that were traditionally challenging. Using a multi-instrument platform, we observed the process of cell culture production and quality control of biologics, including metabolite identification, full protein, subunit, peptide fragment, and N-Glycan analysis, as well as antibody drug conjugates (ADC), oligonucleotides, proteins, and peptides. Innovations with client server (CS) and database (DB) can be implemented in commercial GMP and non-GMP facilities like innovative biopharma, biosimilar labs, CRO, CMO and CDMO.
Transition of 2D-LC from Research to Mainstream Pharmaceutical and Biopharmaceuticals.
C.J. Venkatramani, Genentech Inc., Cupertino, CA, USA; Jens Meixner, Agilent Technologies, Inc., Waldbronn, GERMANY
In the last decade, multi-dimensional chromatography has emerged from being an analytical tool in the hands of few select researchers to mainstream pharmaceuticals, biopharmaceuticals, food and beverages, polymers and other industries around the world. Since then, additional features, such as multiple heart-cutting and high-resolution sampling, have increased flexibility and optimized quantitative results while Active Solvent Modulation facilitates challenging solvent combinations. Increased sample complexity, emergence of hybrid modalities, and compounds with multiple chiral centers have mandated the use of two-dimensional chromatography to unravel and characterize these samples. This presentation will cover several examples ranging from small molecule pharmaceuticals, ADC’s, mixed modalities like antisense oligonucleotides, polypeptides, and addressing potential health agency queries. Additionally, novel strategies to couple complementary techniques like RPLC-HILIC, GPC-RPLC will be presented. Join us on our journey through the previous decade of development, see how 2D-LC can be used today and what it offers for the future.