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Mar 17, 2015 – MSDG Meeting

NJ-ACS Mass Spec Discussion Group

The NJ Mass Spectrometry Discussion Group presents its March Meeting on Tuesday, Mar 17, 2015 at at the Holiday Inn Somerset-Bridgewater, 195 Davidson Ave, Somerset NJ 08873 [ website ]

Sponsored by Bruker Daltonics

Bruker Datonics, Inc

The evening is free for attendees, courtesy of our sponsor!

Please register here.

Featured Speakers:

I. Dr. Wendy Zhong

Principal Scientist, Merck Research Lab

“Top Down Approach on Low Level Unknown Determination of Therapeutic Peptides and Proteins using High Resolution FT-ICR MS platform”

II. Dr. Shannon Cornett,

Applications Development Manager, Bruker Daltonics

New tools for extracting more information from molecules in tissue using solarix XR

Program

5:30 pm – Social and registration
6:15 pm – Complimentary dinner
7:00 pm – Welcome and opening remarks
7:05 pm – Dr. Wendy Zhong
8:00 pm – Dr. Shannon Cornett
8:55 pm – Closing remarks

Abstract for Talk I:

MALDI imaging from tissue can open new insights into the molecular changes associated with biological state.  However, knowing how an ion distributes within the tissue is merely an entry point for extracting molecular information.  High resolution mass spectrometry can provide some degree of identifying information, particularly for smaller molecules where a unique formula id can usually be established from accurate mass.

Identifying larger molecules presents even greater challenges that require other tools and strategies which we are actively developing.  For molecules up to several hundred Daltons in mass (i.e. lipids and small peptides , new detection technologies have been implemented into solarix XR which resolve the isotopic fine structures (IFS).  With IFS information it is possible to count the number of heteroatoms in the molecule which can allow unambiguous formula identification when accurate mass alone, is not sufficient.

Large proteins are typically outside the typical detection range of solarix but, using on-tissue digestion, solarix XR can image tryptic peptides as proxies to the parent protein distributions.  Protein identification directly from tissue does not offer high numbers of ids but with imageID strategies hundreds of proteins identified by high-performance qTOF can be matched with high resolution solarix XR ion images.  Using these tools a greater amount of information can be extracted from complex samples with minimal extra effort.

Abstract for Talk II:

Therapeutic peptides and proteins have become a rapidly increasing sector of today’s pharmaceutical market. However, peptide and protein pharmaceuticals are chemically and physically unstable in nature. Degradants and impurities can be generated during manufacturing and storage, leading to inactivation or worse, to toxicological responses. Due to quality and safety concerns, the demand in analytical technologies to rigorously characterize degradants and impurities of these large and complex biomolecules has increased dramatically.

High resolution mass spectrometry plays a leading role in protein structure determination. Compared to other high resolution MS instruments such as Orbitrap and TOF instruments, a Fourier transform ion cyclotron resonance (FT-ICR) mass spectrometer is particularly powerful in determining protein sequence via top down approach due to its ultra-high mass resolution and high mass accuracy capability. In this presentation, several case studies will be discussed to demonstrate the unique capabilities of ultra-high resolution in structure elucidation of impurity and degradation products in large peptides and proteins. An example of using a NanoMate/CASI (Continuus Accumulation of Selected Ion) technology coupled with ECD (Electron Capture Dissociation) to determine isomeric structures for degradation products in large peptides using a top down approach will also be elaborated. Its unique capability is to determine the low level impurity in a mixture without LC separation and isolation, which could result a very quick turnaround time. Micro to nano scale sample consumption can be readily achieved via NanoMate.

2015-03-17

(Past Events)

Feb 10, 2015 – MSDG Meeting

NJ-ACS Mass Spec Discussion Group

The NJ Mass Spectrometry Discussion Group presents its February Meeting on Tuesday, Feb 10, 2015 at at the Holiday Inn Somerset-Bridgewater, 195 Davidson Ave, Somerset NJ 08873 [ website ]

Sponsored by AB Sciex

AB Sciex

The evening is free for attendees, courtesy of our sponsor!

Please register here.

Featured Speakers:

I. Dr. Zamas Lam

Senior Vice President & Global Head of Pre-Clinical Development at QPS

In Vitro Species Comparison Using Long-Term Hepatocyte Co-Cultures Model and Integrated Qualitative/Quantitative UHPLC-HRMS with Data Independent MS/MS

II. Dr. Suma Ramagiri,

Global Technical Marketing Manager, Pharma/CRO Business at AB Sciex

Antibody Drug Conjugates-Integrated LC/MS strategies for multiple component analysis

Program

5:30 pm – Social and registration
6:15 pm – Complimentary dinner
7:00 pm – Welcome and opening remarks
7:05 pm – Dr. Zamas Lam
8:00 pm – Dr. Suma Ramagiri
8:55 pm – Closing remarks

2015-02-10

(Past Events)

Oct 21, 2014 – MSDG Meeting

NJ-ACS Mass Spec Discussion Group

The NJ Mass Spectrometry Discussion Group presents its October Meeting on Tuesday, Oct 21, 2014 at at the Holiday Inn Somerset-Bridgewater, 195 Davidson Ave, Somerset NJ 08873 [ website ]

Sponsored by Shimadzu

Shimadzu

The evening is free for attendees, courtesy of our sponsor!

Please register here.

Featured Speakers:

I. Kevin Schug, Ph.D.

Shimadzu Distinguished Professor of Analytical Chemistry, Department of Chemistry & Biochemistry, The University of Texas at Arlington

On-Line Preparation, Separation, and Quantitative Determination of Small and Large Molecules in a Multipath Liquid Chromatography – Mass Spectrometry System

II. Fred Regnier,

J.H.Law Distinguished Professor of Chemistry Emeritus, Purdue University and C.E.O of Novilytic. West Lafayette, Indiana

“Sample Preparation: The Achilles Heel of Rapid Mass Spectral Analysis”

Program

5:30 pm – Social and registration
6:15 pm – Complimentary dinner
7:00 pm – Welcome and opening remarks
7:05 pm – Dr. Kevin Schug
8:00 pm – Prof. Fred Regnier
8:55 pm – Closing remarks

Abstract for Talk I:

Many precious biological samples may contain multiple analytes of interest; these may span the range from small molecule metabolites to large proteins. Typically, sample preparation, analytical separation, and quantitative determination schemes for different classes of chemical compounds can vary substantially – so much so that they require completely separate analyses. It has been our goal to develop a multipath liquid chromatography – mass spectrometry system, which enables sample preparation and analysis of multiple chemical compound classes from a single injection. Through integrated restricted access media, multiple valves, and flow-paths, it is possible to segregate the components of a complex biological mixture and facilitate their separation on appropriate chromatographic phases, followed by ultra-trace detection on a triple quadrupole mass spectrometer. This could be desirable to streamline analysis of, for example, multiple biomarkers or small and large molecule conversion products of biotherapeutics, simultaneously in one analytical run. This talk will describe our progression of work aimed towards those ends, including development of methods for: Ultra-trace determination of small molecules using bulk derivatization and restricted access media; optimization of multiple reaction monitoring schemes for intact protein analysis; and integration of these components into a single multipath instrument for segregation and simultaneous separation and determination of small and large molecule analytes.

Abstract for Talk II:

    The issue of how to rapidly identify and quantify multiple substances in biological samples is a subject of great interest today, particularly in drug metabolism and pharmacokinetics, biomarker discovery and validation, clinical diagnostics, and translational medicine. The potential of mass spectrometry (MS) in this arena is a function of how fast data can be acquired from highly complex biological samples. Although MS can identify and quantify hundreds of analytes within msec, sample preparation frequently takes 12-24 hours. Clearly sample preparation is a substantial problem in addition to being boring, labor intensive, and costly. This presentation will examine ways in which this problem can be circumvented.

    The fact that biological samples contain cells along with greater than 105 molecular species means that multiple types of prefractionation must occur before introduction into an MS. Cell removal, analyte extractions and enrichment, and subtraction of interfering substances are all part of the sample preparation process. Chemical modifications of analytes ranging from derivatization to digestion are also necessary in many cases. Finally there is the issue of sample origin. When samples are derived at a source other than the MS lab there is the issue is how to get them to the laboratory, what happens to them en route, and following their identity as they pass through multiple preparation steps.

    Clearly these problems can be minimized by automation. But the problem is more complicated than that. Automating multiple individual steps still takes a lot of space and probably does not reduce sample preparation time. A focus of this presentation will be on how to automate multiple steps of sample preparation simultaneously in a single device.

2014-10-21

(Past Events)

Sep 29, 2014 to Oct 1 – MSDG at CPSA

NJ-ACS Mass Spec Discussion Group MSDG at CPSA 2014


 
NJ-MSDG participates annually in CPSA, a three-day conference on Clinical & Pharmaceutical Solutions through Analysis held at the Sheraton Bucks County Hotel, in Langhorne, PA. Typically, MSDG organizes a session and co-sponsors the Keynote Address and Banquet. MSDG members have free admission to those two events, but separate registration is required, for planning.

CPSA Click [ CPSA USA ] for the full program and directions. Conference fee is $360, short courses $260. Registration is at http://www.cpsa-usa.com/2014/registration.shtml. MSDG members get a discount on conference registration.

  1. CPSA Workshop (sponsored by NJ-MSDG!) – Mon, Sept 29, 2014 / 2-4PM“From Nature’s Products to Biologics – Applications of Advanced Analytical Technologies”   Discussion Leaders: Ronald Kong, PTC; Min Liu, Merck; Jasmine Lu, Shimadzu, Sponsored by the North Jersey ACS Mass Spectrometry Discussion Group. (Separate registration for this event required by clicking here. No charge for NJ-MSDG members).
  2. CPSA – Wed, Oct 1, 2014 / 3:45PM onwardsVendors’ 5 minutes of Fame – followed by CPSA Dinner Lectures & Award Presentations, held in conjunction with our MSDG group and the Del Val Drug Metabolism Discussion Group. (Separate registration for this event required by clicking here).

2014-10-01

(Past Events)

Sep 16, 2014 – MSDG Fall Vendor Show & Symposium

NJ-ACS Mass Spec Discussion Group
The New Jersey Mass Spectrometry Discussion Group (NJ MSDG) Vendor Show and Vendor Sponsored Workshop will be held on September 16, 2014, at the Holiday Inn Somerset-Bridgewater (195 Davison Avenue, Somerset, NJ 08873). We are fortunate to have Dr. Lucinda Cohen from Merck & Co. and Professor Jonathan Sweedler from University of Illinois at Urbana-Champaign, as our Distinguished Lecturers. There will also be a special celebration to recognize the 25 year anniversary of the NJMSDG. Additional information will be posted as it becomes available. [ hotel website ]

Attendance is free of charge, compliments of our sponsors!

Please register here.

Schedule of Events:

2:30 – 3:00 PM Vendor Set Up – Hotel Ballroom
3:00 – 4:00 PM Registration – Hotel Ballroom
4:15 – 4:45 PM Cocktail Break / vendor interaction
4:45 – 5:45 PM Presentation by Dr. Lucinda Cohen (Merck)
5:45 – 7:00 PM Buffet Dinner (Raffle prizes will be announced)
7:00 – 8:00 PM Presentation by Prof. Jonathan Sweedler (University of Illinois)

 

2014-09-16

(Past Events)

Jun 23, 2014 – MSDG Meeting

NJ-ACS Mass Spec Discussion Group

The NJ Mass Spectrometry Discussion Group presents its May Meeting on Monday, June 23, 2014 at at the Renaissance Woodbridge Hotel, 515 US Highway 1 South, Iselin  NJ 08830 [ hotel website ] –  Note change in day-of-week and venue.

Sponsored by Thermo Fisher Scientific

Thermo Fisher Scientific

Attendance is free of charge, compliments of our sponsors!

Please register here.

Featured Speakers:

I.   Jonathan Josephs

 Thermo Fisher Scientific,  Director – Global Biopharma Marketing

II. Tim Stratton

Thermo Fisher Scientific, Strategic Marketing Specialist, Metabolism and Metabolite Identification, Life Sciences Mass Spectrometry

Program

5:30 pm – Social and registration
6:15 pm – Complimentary dinner
7:00 pm – Welcome and opening remarks
7:05 pm – Jonathan Josephs
Thermo Fisher Scientific
Director – Global Biopharma Marketing
8:00 pm – Tim Stratton
Thermo Fisher Scientific
Strategic Marketing Specialist
Metabolism and Metabolite Identification
Life Sciences Mass Spectrometry
8:55 pm – Closing remarks

2014-06-23

(Past Events)

May 6, 2014 – MSDG Meeting

NJ-ACS Mass Spec Discussion Group

The NJ Mass Spectrometry Discussion Group presents its May Meeting on Tuesday, May 6, 2014 at at the Holiday Inn Somerset-Bridgewater, 195 Davidson Ave, Somerset NJ 08873 [ hotel website ]

Sponsored by Waters

Waters

Attendance is free of charge, compliments of our sponsors!

Please register here.

Featured Speakers:

I. James Settlage Ph.D.

Inventiv Health Clinical, Princeton, NJ

Leveraging the power of Supercritical Fluid Chromatography coupled with Triple Quadrupole Mass Spectrometry to meet otherwise intractable bioanalytical challenges

II. Gene Ciccimaro, Ph.D.

Bristol-Myers Squibb, Lawrenceville, NJ

Meeting the Needs of Biopharma Drug Discovery by Increasing Sensitivity Using ionKey Technology and Protein Immunoenrichment Cleanup

Program

5:30 pm – Social and registration
6:15 pm – Complimentary dinner
7:00 pm – Welcome and opening remarks
7:05 pm – Dr. Settlage
8:00 pm – Dr Ciccimaro
8:55 pm – Closing remarks

Abstract for Talk II:

    Current challenges facing the Discovery Bioanalyst include the need to understand the biology of preclinical disease models and demonstrate on target effects. Perturbations of biomarkers, protein ligands and receptors need to be quantified in both circulation and in tissues from target organs. Bioanalytical assays to provide this data require exquisite sensitivity due not only to extremely low endogenous levels, but also limited sample volume. To overcome these demands, we attempt to incorporate sample cleanup using immunoenrichment followed by low flow LC-MS technology using the ionKey micro column tile emitter and TQS mass spectrometer. There is a known asymptotic increase in analyte ESI-MS signal response with reduced solvent flow rate. Considering optimal QqQ instrumental ion transfer efficiency loss, a reduction from traditional flow rate (400-800 µL/min) to low micro-flow rates (1-5 µL/min) will on average result in 10-30X, and a reduction to nano-flow rate (<1 µL/ min) will result in ~ 50X gain in signal intensity. These intensity gains however, do not directly correlate to gains in analytical assay sensitivity (reduced LLOQ). In this study we highlight this disconnect when porting a protein immunoenrichment method from traditional to micro-flow LC-MS/MS. We identify charge competition as the cause for the performance gap, and show results from an improved sample preparation that achieves improved assay performance by maximizing sample loading and minimizing charge saturation. We highlight the use of this technology to support drug discovery efforts. Authors: Bogdan Sleczka, Eugene Ciccimaro, John Mehl, Lorell Discenza, Asoka Ranasinghe, Celia D’Arienzo, Timothy Olah (Bristol-Myers Squibb, Lawrenceville, NJ). Catalin Doneau, Brad Coopersmith, Jim Murphy (Waters)

2014-05-06

(Past Events)

Apr 8, 2014 – MSDG Meeting

NJ-ACS Mass Spec Discussion Group

The NJ Mass Spectrometry Discussion Group presents its April Meeting on Tuesday, Apr 8, 2014 at at the Holiday Inn Somerset-Bridgewater, 195 Davidson Ave, Somerset NJ 08873 [ website ]

Sponsored by Agilent Technologies

Agilent Technologies

Attendance is free of charge, compliments of our sponsors!

Please register here.

Featured Speakers:

I. Daina Avizonis

PhD, Manager / Research Associate, Metabolomics Core Facility,
McGill University, Goodman Cancer Center

Fueling Cancer: Using Metabolomics to Study Cancer Biology”

II. Jim Lau

PhD, Sr. Applications Scientist, Agilent

Qualitative and Quantitative Analysis of Lipids using SFC and LC combined with High Resolution Accurate Mass MS

Program

5:30 pm – Social and registration
6:15 pm – Complimentary dinner
7:00 pm – Welcome and opening remarks
7:05 pm – Dr. Avizonis
8:00 pm – Dr Lau
8:55 pm – Closing remarks

2014-04-08

(Past Events)

Mar 11, 2014 – MSDG Meeting

NJ-ACS Mass Spec Discussion Group

The NJ Mass Spectrometry Discussion Group presents its March Meeting on Tuesday, Mar 11, 2014 at at the Holiday Inn Somerset-Bridgewater, 195 Davidson Ave, Somerset NJ 08873 [ website ]

Sponsored by Bruker Daltonics Inc

Bruker Daltonics Inc

Attendance is free of charge, compliments of our sponsors!

Please register here.

Featured Speakers

I. Jason W. Wood

PhD, Market Manager – Pharma/Biopharma Bruker Daltonics Inc.

Real or Artifact? Getting Closer to Reality in Biotherapeutic Characterization

II. Keith Johnson (co-authors: Heather DeGruttola, Andrew Saati, Lisa A. Marzilli and Jason C. Rouse)

Mass Spectrometry and Biophysical Characterization Group, Analytical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc

Applications of Ultrahigh-Resolution Mass Spectrometry to Biotherapeutics Characterization

Program

5:30 pm – Social and registration
6:15 pm – Complimentary dinner
7:00 pm – Welcome and opening remarks
7:05 pm – Dr. Jason Wood
8:00 pm – Dr. Keith Johnson
8:55 pm – Closing remarks

Abstract for Talk I:

There are many tools available for the characterization of biotherapeutics including advanced hardware and software as well as multiple novel enzymes for digesting large molecules into specific fragments for further analysis in a more ‘bottom-up’ approach. However, enzymatic digests can lead to artifacts which may further complicate the analysis of these large biomolecules. Here we present a workflow for the analysis of antibodies with minimal enzymatic digestion and MALDI-TOF/TOF analysis, allowing for fewer artifacts and more accurate characterization”

Abstract for Talk II:

Therapeutic proteins are characterized methodically with respect to primary structure, posttranslational modifications, charge and size heterogeneity, higher order structure, and biological activity, in concert with process and product development, to achieve a comprehensive understanding of the active substance prior to commercialization. The ESI-quadrupole-time-of-flight (QTOF) mass spectrometer is well-established in the heightened characterization of protein therapeutics, and is highly suited for antibodies, antibody-drug conjugates, fusion proteins, novel constructs, and vaccines. This single instrument platform provides detailed structural information for the intact protein molecule, as well as for the subunits/domains, proteolytic peptides, and released N-glycans (if present) in orthogonal analyses. The newest generation of ultrahigh-resolution (UHR) ESI-QTOF mass spectrometers offers significant improvements in critical performance parameters such as resolution, mass accuracy, sensitivity and dynamic range. These instruments, in conjunction with new approaches to protein characterization, provide accurate measurements to within 2 ppm of theoretical values for isotopically-resolved proteins ≤35 kDa, which is ideal for the detailed analysis of whole antibody subunits/domains and smaller single-chain proteins.

In this presentation, a comparison of newer LC/MS-subunit analysis methods for antibody characterization will be discussed that improve on traditional reduction/alkylation, and light and heavy chain subunit mass analysis. Through hinge region-proteolysis and disulfide bond reduction, heavy chain (~50 kDa) essentially can be cleaved homogeneously into two domain fragments (~25 kDa each) with molecular masses more similar to light chain (~24 kDa). Since UHR QTOF MS excels in this 10-35 kDa mass range, these newer approaches to subunit analysis afford more sensitive detection and definitive identification of both expected and unexpected antibody modifications at the whole subunit/domain level, all in a rapid manner – in contrast to traditional, data-intensive proteolytic mapping at the peptide level. In addition, rapid confirmation of the amino acid sequence at the subunit/domain level and detection of potential sequence variants and mis-incorporations during the early stages of process development will be demonstrated with these new methods. Finally, current endeavors regarding automated data analysis for all LC/MS methods will be presented.

2014-03-11

(Past Events)

Nov 5, 2013 – MSDG Meeting

NJ-ACS Mass Spec Discussion Group

Note: There are two meetings coming up soon:
[ Oct 22 in NJ | Nov 5 in NJ ]

The NJ Mass Spectrometry Discussion Group presents its November Meeting on Tuesday, Nov 5, 2013 at at the Holiday Inn Somerset-Bridgewater, 195 Davidson Ave, Somerset NJ 08873 [ website ]

Sponsored by AB Sciex

AB Sciex

Attendance is free of charge, compliments of our sponsor!

Please register here.

Featured Speakers

I. Chongwoo Yu, Ph.D.

Senior Clinical Pharmacology Reviewer Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center of Drug Evaluation and Research (CDER), U.S. Food and Drug Administration

“The Role of Bioanalysis in Drug Development”

II. St John Skilton, Ph.D.

Sr. Manager Global Markets, Biologics, AB SCIEX

“Biologics Workflow: How Can We Move from Complex Samples to Direct Answers?”

Program

    5:30 pm Social and registration
    6:15 pm Complimentary dinner
    7:00 pm Welcome and opening remarks
    7:05 pm Dr. Chongwoo Yu
    8:00 pm Dr. St John Skilton
    8:55 pm Closing remarks

Abstract for Talk I:

    Clinical Pharmacology plays an important role in drug development, including the evaluation of the drug’s pharmacokinetics (PK), pharmacodynamics (PD), drug interaction potential, exposure-response relationship, and safety considerations when being used in specific populations.

    Clinical Pharmacology data is pivotal in delivering the right drug, in the right dose, at the right time, to each particular patient and it has significantly influenced the risk/benefit assessment and labeling recommendations. Consequently, the reliability of that data is of considerable importance and bioanalysis is the solid footing in drug development ensuring the reliability. Bioanalytical data and documentation from method validation or clinical trials are critical elements supporting regulatory submissions such as new drug applications (NDAs) or biologics license application (BLAs).

    Case examples will be presented to highlight the utility and importance of bioanalysis in drug development to ensure that drug products are safe, effective, and given at the right dose.

Abstract for Talk II:

    The last few years have seen an abundance of biologics (from peptides to monoclonal antibodies) entering the pharmaceutical pipeline, and it is believed that in the next few years, the pharmaceutical pipeline will contain nearly 50% biologics. In addition, with the patent expiration of several biologics recently, and many more scheduled to come off patent in the future, there is likely to be a steady rise in the number of biosimilars on the market. However, developing robust and reproducible LC/MS or sensitive LC/MS/MS methodologies to characterize and quantify these diverse compounds is significantly more complicated from those developed for small molecules. An evolving regulatory environment, particularly in the late stage studies for both innovator biologics and follow-on biosimilars, adds to this complexity.

    As a result there is an increased demand for simple workflows using LC/MS or LC/MS/MS that offer users the ability to develop sensitive, robust, and reproducible methods that address regulatory demands as required. This talk will highlight the workflows that were used for characterization of the key features of Biologics using an LC/MS platform with time-of-flight technology, inclusive but not limited to: advanced peptide mapping, whole protein analyses, Antibody Drug Conjugate characterization, sequence variant analysis, and identification and quantitation of Host Cell Proteins.

2013-11-05

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