Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Seminar Price Details

Seminar Fee for One Delegate
Price : US$1,199.00

Register for 5 attendees
Price : US$5,995.00

Register for 10 attendees
Price : US$11,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Why you should attend

The course will guide you through the different assays needed (ligand binding and cell based assays) in each process step and how to set them up and validate them under the current regulatory documents and with regards to GLP/GCP/GMP. 

Who Will Benefit

  • Anyone involved in biotech and pharma working with assays, regulatory, quality assurance 

Agenda

Day 1 Schedule

Drug development and basics of biological assays

  • The drug development pipeline for biologics
  • Biosimilars
  • Regulatory demands
  • What assays are out there? Potency, PK, immunogenicity

Development of immunoassays

  • Critical factors in assay development
    • Plates
    • Buffers
    • Critical reagents
  • Design of Experiment

Development of bioassays

  • Design of Experiments continued in view of bioassays
  • Critical factors for bioassays such as edge effect

Basics of immunogenicity assays

  • Definition of immunogenicity
  • Why are biologics immunogenic? The immunological view
  • The assays compared to PK/potency, e.g. drug tolerance
  • The tiered approach in immunogenicity
    • Screening
    • Confirmation
    • Neutralization

Day 2 Schedule

Bioanalytical statistics

  • Curve fitting: 4PL and 5PL
  • Applying a weighting function 
  • Parallelism vs equivalence with regards to EuP and USP

Validation/qualification of immunoassays

  • History of validation
  • GxP system
  • Guidelines (USP, ICH, FDA, EMA)
  • Regulatory requirements in detail 
    • Standard Curve
    • Accuracy
    • Precision
    • Selectivity/Specificity
    • Parallelism
    • Dilutional Linearity 
    • Ruggedness/Robustness 
    • Stability
    • Incurred sample reanalysis

Validation/qualification of bioassays

  • Qualification versus validation: the tiered approach in bioanalysis
  • Tiered approach versus fit-for-purpose approach in immunogenicity testing
  • Full/partial and cross validation 
  • Validation designs and implementation
  • Additional considerations with bioassays (cell-based)

Assay troubleshooting

  • Monitoring assay performance over time
  • Identifying and managing sources of assay variability
  • Analysing and optimising assay performance
Each chapter will have practical examples and 1-2 major case studies will be examined and discussed. 
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161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
US: (510) 962-8903
Zurich, Switzerland: +41 - 43 434 80 33

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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Melody Sauerborn 

Immunologist and Virologist,
Freelancer


Melody Sauerborn, by background an immunologist and virologist, literally stumbled into the world of biologics when entering her PhD. During her PhD she investigated the correlation between protein aggregates and immunogenicity in transgenic mouse models under the supervision of Prof. Huub Schellekens and Prof. Wim Jiskoot. The years following her PhD, Dr. Sauerborn expanded her experience in bioanalytical methods by working as a project leader, trainer and senior expert in CROs and biotech companies.

Her expertise includes: set up and validation of immuno- and bioassays, immunogenicity, manufacturing (in specific potency assays) and all regulatory framework connected with it. She is experienced in GLP/GCP/GMP, and FDA, EMA, USP, EP and ICH guidelines with regards to small molecules, biologics and vaccines. Dr. Sauerborn also acts as an evaluator for the Swedish innovation agency, Vinnova, where she rates business proposals of start-up biotech companies competing for seed funding.

As a freelancer and interim manager, Dr. Sauerborn enjoys the variety of her projects and is blessed with being able to share her experience by teaching workshops and webinars around the world.

Venue

Location: Zurich, Switzerland
Hotel: Hilton Zurich Airport