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Biotherapeutics Analytical Summitt

Hyatt Regency Baltimore * | Baltimore, USA
From 1399 to 2899 USD
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Title: Biotherapeutics Analytical Summitt
Specialty: Radiology
Dates: From Mar, 9, 2015 to Mar, 13, 2015
Location: Baltimore, USA
Type: Summit
Registration Cost: From 1399 to 2899 USD
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Weather Info (monthly averages) Max Temperature: C / F Min Temperature: C / F The above data in our Weather Info table are temperature predictions for the date of the medical event for BALTIMORE, Usa.
General Info
Event Venue:

Hyatt Regency Baltimore *

BALTIMORE, USA Visit the Venue to read more
Currency:
USD
Concerned Audience:
  • Medical_Professionals
  • Medical_students
  • Nurses
Event Overview
Welcome message:

SC1: Host Cell Protein Measurements: Thoughts of the USP Expert Panel and Best Practices - Detailed Agenda 

Instructors:

Martin Vanderlaan, Ph.D., Director, Analytical Operations, Genentech, Inc.

Maura Kibbey, Ph.D., Senior Scientist Liaison, Biologics and Biotechnology, US Pharmacopeia

Ned Mozier, Ph.D., Senior Director, Analytical R&D, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.

Agenda outline:

A short course presented by key participants in the USP draft monograph on HCPs that has been posted for comments and will have been finalized by the time of the conference. It will examine the key points and controversial issues with explanations of nuances and compromises that needed to be made. It will also examine and advise on critical issues in HCP analysis.

  • Role / Intent / Timing for USP Chapter
  • Key Observations from the USP Expert Committee on Host Cell proteins
  • Making suitable antibodies for HCP assays (antigen preparation and antibody purification methods)
  • Characterization of the quality of antibodies (a variety of means, including “coverage)
  • Development of Platform vs. Specific HCP assays (and lifecycle management)
  • Orthogonal methodology for HCP detection and integration with Immunoassay data
  • HCP method development, data analysis best practices– including cases where dilutional linearity is lacking
  • Co-purification of HCPs with products: signs, causes, solutions
  • Regulatory Interest and involvement
  • Validation of HCP immunoassays
  • Clinical Issues with HCPs
  • Roundtable discussion

SC2: Sub-Visible Particles, Aggregates and Impurities: Measurement, Characterization and Impact Detailed Agenda 

Instructors:

Patricia W. Cash, Ph.D., Senior Director, Analytical Biotechnology, Biopharmaceutical Development, MedImmune, Inc.

Dean Ripple, Ph.D., Group Leader, Bioprocess Measurement Group, National Institute of Standards and Technology

Nadine Ritter, Ph.D., President & Senior Analytical Advisor, Global Biotech Experts LLC

Agenda outline:

Introduction to SVPs, Aggregates and Impurities

  • Current regulatory expectations
  • Mechanisms behind formation of soluble aggregates and SVPs
  • Potential biological impacts

Overview of Aggregates

  • Causes of aggregation
  • Characterization
  • Current concerns in the context of immunogenicity with examples
  • Elimination of aggregates through protein refolding and high pressure dissociation and other methods

Technologies and Tools for Identification and Characterization

  • Aggregates (Size exclusion SEC, AUC, FFF, etc.)
  • Sub-visible (Microflow imaging, light obscuration, etc.)
  • Comparisons between technologies regarding limits of detection
  • Open Discussion on which approaches can be regarded as FDA compliant

Recent Experiences and Case Studies Discussion with Q&A 

SC3: Glycobiology of Antibodies Detailed Agenda  

Instructor:

T. Shantha Raju, Ph.D., Scientific Director, Biologics Research, Janssen Research & Development, LLC

Agenda outline:

  • Introduction to Protein Glycosylation
  • Fc Glycan Heterogeneity
  • Methods to Analyze Fc Glycans
  • Glycoengineering Methods
  • Role of Fc Glycans on Antibody Effector Functions
  • Impact of Fc Glycans on Antibody Stability
  • Discussion with Q&A
Registration Needs updating Register Now
Currency:

USD

Registration Cost
Type
Early Registration

2015-01-09
Late Registration From: 2015-01-10 To: 2015-01-30
On site Registration
Registration
2899
1399
0

Group Registrations:

Group registrations not allowed

Accompanying Persons:

Accompanying persons not allowed

Registration Documents:
Letter of invitation:
We don’t provide letter of invitation
Letter of confirmation:
We don’t provide Letter of Confirmation
Proof of professional / educational status:
We don’t need Proof of professional/educational status
Online Abstract Submission:

We don’t accept Online Abstracts

Accommodation
Accommodation:

Hyatt Regency Baltimore
300 Light Street
Baltimore, MD 21202
T: 410-528-1234

Room Rate: $229 s/d (rate includes complimentary wireless internet access in guest room)
Reservation Cutoff: February 10, 2015 

Please click here or call the hotel directly to reserve your sleeping accommodations.  You will need to identify yourself as a Cambridge Healthtech conference attendee to receive the discounted room rate with the host hotel.  Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space and rate-availability basis.  Rooms are limited, so please book early to take advantage of the discount we have negotiated.

Top Reasons to Stay at the Hyatt Regency Baltimore: 

  • Complimentary wireless internet in your guest room
  • No commute to conference venue
  • A quick taxi ride (10 miles) from Baltimore International Airport (BWI)
  • Only four blocks from the Metro subway system and only three blocks from the Lightrail
  • Take advantage of the discounted group rate

 We understand that you have many choices when making your travel arrangements. Please understand that reserving your room in the CHI room block at the conference hotel allows you to take full advantage of the conference sessions, events and networking opportunities, and ensures that our staff will be available to help should you have any issues with your accommodations.  

Scientific Content Up to Date
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General Info

CHI offers comprehensive packages that can be customized to your budget and objectives. Sponsorship allows you to achieve your goals before, during, and long after the event. Packages may include presentations, exhibit space and branding, as well as the use of delegate lists. Signing on early will maximize your exposure to qualified decision-makers and drive traffic to your website in the coming months.

Podium Presentations — Available within Main Agenda! 

Showcase your solutions to a guaranteed, targeted audience through a 15- or 30-minute presentation during a specific conference program, breakfast, lunch, or separate from the main agenda within a pre-conference workshop. Package includes exhibit space, on-site branding, and access to cooperative marketing efforts by CHI. For the luncheon option, lunches are delivered to attendees who are already seated in the main session room. Presentations will sell out quickly, so sign on early to secure your talk!

Invitation-Only VIP Dinner/Hospitality Suite 

Select specific delegates from the pre-registration list to attend a private function at an upscale restaurant or a reception atthe hotel. From extending the invitations, to venue suggestions, CHI will deliver your prospects and help you make the most of this invaluable opportunity.

Focus Group

CHI will gladly provide you the opportunity of running a focus group on-site. This exclusive gathering can be useful to conduct market research, collect feedback on a new product idea, and collect marketing intelligence from industry experts on a specific topic.

User Group Meeting/Custom Event 

Co-locate your user group meeting or custom event. CHI will help market the event, manage logistical operations, develop the agenda, and more. CHI can handle the entirety of the meeting or select aspects.

Exhibit 

Exhibitors will enjoy facilitated networking opportunities with qualified delegates, making it the perfect platform to launch a new product, collect feedback, and generate new leads. Exhibit space sells out quickly, so reserve yours today!

Additional branding and promotional opportunities are available, including:

  • Conference Tote Bags
  • Literature Distribution (Tote Bag Insert or Chair Drop)
  • Badge Lanyards
  • Program Guide Advertisement
  • Padfolios and More...

For additional sponsorship & exhibit information, please contact:
Jon Stroup
Sr Business Development Manager
781-972-5483 | jstroup@healthtech.com 

Contact
Organising Agency


250 First Avenue Suite 300
Needham, MA 02494
P: 781.972.5400
F: 781.972.5425
E: chi@healthtech.com

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