Immunogenicity Summit
Immunogenicity and Bioassay Summit

Short Course 3 - PK/PD Bioanalysis for Novel Biotherapeutics 

Sunday, November 10, 2014


5:30 - 8:30 pm Dinner SC3: PK/PD Bioanalyis for Novel Biotherapeutics

Hosted by Gyros

Novel constructs, such as anti-drug conjugates (ADCs) and bispecific antibodies, now exist as promising candidates in biotherapeutic pipelines. With aggressive timelines and contraction in the biopharma labor force, assay development can pose challenges beyond typical assays for pharmacokinetics and pharmacodynamics. Several bioanalytical techniques can be employed to measure these novel constructs. This short course will cover assay technologies to measure ADCs and bispecific antibody therapeutics for pharmacokinetics and pharmacodynamics presented by various biopharma scientists.

5:30 Moderator’s Opening Remarks:

Robert Durham, Ph.D., Director, Field Applications, North America, Gyros US, Inc.

5:35 The Gyrolab™ Immunoassay System: Platform for Automated Analysis of Biopharmaceuticals Including Bispecific Therapeutics 

Lee Abberley, Ph.D., Team Leader, DMPK, GlaxoSmithKline, US

The Gyrolab™ platform has been shown to be a viable alternative to “manual” immunoassays at GSK.  A number of regulated assays have been transferred onto the Gyrolab™ platform including a bispecific mAb-dAb method.  The presentation will include details around method development and method validation, and a discussion of the data transfer from the Gyrolab™ to a LIMS system using  GSK proprietary companion software. 

6:50 Break

7:10 Moderator’s Remarks

Robert Durham, Ph.D., Director, Field Applications, North America, Gyros US, Inc.

7:15 Measurement of ADCs: How, What and When

Lindsay E. King, Ph.D., Senior Principal Scientist, Pfizer Inc

Antibody drug conjugates (ADCs) are complex Biotherapeutics composed of an antibody conjugated to a small molecule drug (payload) designed to target delivery to specific cells. A variety of linkers, payloads and conjugation sites may be evaluated in programs before a lead candidate is selected. ADC are dosed as a population of molecules with different antibody-drug ratios (DAR), in some cases with a great deal of heterogeneity in the drug conjugation sites The pharmacokinetics of these in both efficacy and exploratory toxicology studies typically requires that both ligand binding and LC/Ms assays are developed in order to measure different analytes. This data generated is used to help select leads, determine a therapeutics index and a tumor static concentrations. This talk will introduce the analytical methods that are used to measure ADCs, the challenges and the approaches used to address the heterogeneity of these molecules as well as implications for decision making.

8:30 End of Short Course

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