Coming Webinars

October 05, 2016  
Challenges of supporting multiple programs for PK Bioanalysis: a CRO perspective

15:00 - 16:00
Contract Research Organisations (such as Envigo) are required to transfer, develop, validate and carry out sample analysis on a wide range of drug products from clients. Discussed are various aspects that must be considered when choosing a suitable assay platform for pharmacokinetic (PK) studies.
This presentation compares PK assays on different immunoassay platforms and some of the challenges encountered.
The advantages of running PK sample analysis on the Gyrolab are discussed, along with examples of where transferring of an assay onto the Gyrolab have eliminated assay issues.
For the reasons discussed in this presentation, Envigo now recommends the Gyrolab for PK studies with antibody capture reagents, however, when ligands are used as capture reagents, immunoassay platform suitability must be assessed on a case by case basis.

Speaker:
Deborah McManus
Senior Technical Specialist in the Department of Biomarkers, Bioanalysis and Clinical
Envigo

More Info          Register Now

Recorded Webinars

Automated nanoliter-scale immunoassays to maximize productivity in bioprocess development

This is a recording from April 26, 2016

Modern approaches to bioprocess development require accurate, high throughput analytical methods to match scaled-down, high throughput screening, the application of DoE, and science-based decision making consistent with Quality by Design.

Please join Karolina Österlund, Manager Field Application Scientists EU and Asia, Gyros AB, as she presents Gyrolab™ systems and a range of easy-to-use immunoassay kits as an automated, high-throughput platform for cell line and bioprocess development, illustrated by case studies from Shire, MedImmune and Merck.

View Recording

Automated nanoliter-scale immunoassays to increase efficiency and productivity in bioanalysis

This is a recording from March 25, 2015

Webinar description:
Gyrolab platforms automate nanoliter-scale immunoassays to accelerate assay development and bioanalysis for time critical workflows throughout biopharma development – from preclinical R&D, through bioprocess development and into regulated clinical trials. The affinity flow-through format eliminates incubations and shortens run times. Rapid parallel processing with precision means that Gyros’ technology ensures high reproducibility and productivity, with up to 112 data points generated per CD in under an hour. Gyros’ technology helps your team develop assays in less time than manual methods and increase throughput – quickly, efficiently and reliably.

What will you learn?
• The value of scaling down immunoassays to a nanoliter format
• The high throughput that can be achieved with walk-away automation
• The versatility of Gyros’ technology throughout biopharma development

Speaker

Robert Durham
Director, Field Applications, North America, Gyros, Inc.

Robert Durham, PhD, is currently the Director of Field Application Scientists for Gyros, Inc. in North America. In this role his responsibilities include: managing a team of field application scientists; training and support of new assay development; and qualification and validation on the Gyrolab™ platform. He brings to this position extensive expertise in the development and validation of immunoassays to support translational medicine projects in drug development for neuroscience and pharmacology. Robert received an MS in Biology in 1993 and a PhD in Pharmacology and Neurosciences in 1997 from Michigan State University. He completed a post-doctoral fellowship at Parke-Davis Pharmaceutical Research in 2000, where he evaluated and characterized animal models of Alzheimer’s disease.

View Recording

Streamlining product titer using automated nanoliter-scale immunoassays with throughput, dynamic range & reliable reproducibility

This is a recording from February 10, 2015

Webinar description:
Increasing efficiency and productivity for product titer quantification is even more critical as a result of increasing workloads in supporting multiple programs at different stages with limited resources. Current methods, such as ELISA and HPLC, create bottlenecks in critical workflows because of throughput constraints, limited dynamic range, and longer assay times. In addition, in process analytical testing needs to accommodate different sample types, matrices and a variety of conditions that are variable throughout cell line development and upstream development. Gyros’ technology provides a robust, reproducible alternative to improve analytical support to the ever increasing demands to control product quality and process consistency that is scalable at all stages of development and production. This webinar will focus on the use of automated, nanoliter-scale flow-through technology to address a critical need for improved speed and throughput with high data quality for product titer quantification.
Speakers

Speaker 1:
Rapid Development of Gyrolab Titer ELISAs to Support Biopharmaceutical Process Development
Matt Traylor, Analytical Development, Shire Human Genetic Therapies

Speaker 2:
High Throughput Monoclonal Antibody Titer Assay for BioProcess Development
Jun Heo, Analytical Scientist, Bioprocess Technology and Expression (BTE), Merck & Co., Inc.

Moderator:
Meletios Roussis, Field Applications Scientist, Gyros US, Inc.

View Recording

One mouse, one pharmacokinetic profile: development of a quantitative diluted whole blood serial sampling process for biotherapeutics

This is a recording from September 04, 2014

Summary:

Validation of a method to use mouse serial sampling in combination with Gyrolab™ platform ligand binding assay quantification of the dosed biotherapeutic in diluted whole blood to derive a PK profile is presented.

Introduction: Rodent pharmacokinetic (PK) studies are traditionally done using many animals, in a non-serial testing scheme to create pharmacokinetic profiles. Two challenges for non-clinical biotherapeutic drug discovery are the sampling constraint due to the small size of the testing animal and the inherent variability in the PK profile data when many rodents are used to create one profile. A validation of a method to use mouse serial sampling in combination with Gyrolab™ platform ligand binding assay quantification of the dosed biotherapeutic in diluted whole blood to derive a PK profile is presented. This investigation compared PK parameters obtained using diluted whole blood serial sampling compared to traditional composite sampling following administration of human IgG monoclonal antibody. Additional experiments were conducted to understand possible matrix and sampling site effects on drug concentrations. The diluted whole blood mouse serial sampling along with nanoliter scale Gyrolab® technology allowed for successful implementation of this testing paradigm at Pfizer. Overall efficiencies gained were 40–80% savings in animal usage, decreased study length, and decreased use of drug material while inter-subject variability across PK parameters was less than 30%.

What will you learn:
• Gain insight into challenges and solutions for deriving PK profiles by repeated sampling in non-clinical mouse studies
• Hear how experts in the field are applying mouse serial sampling in the laboratory today
•Learn how microsampling in combination with Gyrolab™ technology can reduce animal usage with 40–80%

Presenter:
Name: Ann-Charlott Steffen
Title: Application Scientist
Company: Gyros AB

Name: Rosemary F Lawrence-Henderson
Title: Scientist
Company: Pfizer

View Recording

Redefining 3Rs for Safety Toxicology Biomarkers using Automated Nanoliter-scale Immunoassays

This is a recording from April 23, 2014

Webinar Description:

Biomarker assays in the development of therapeutics are often challenged with limited sample volumes, slow assay development and the need for high quality data to support analysis from discovery to clinical trials. Current immunoassay methods require sample volumes that necessitate pooling samples from multiple mice for testing. Miniaturizing and automating biomarker immunoassays at nanoliter-scale reduces the number of animals required as Gyrolab™ xP workstation uses 4 µL for duplicate analysis and allows for multiple analyses from a single mouse. Please join scientists from Eli Lilly and EMD Millipore as they present the latest developments in safety toxicology biomarkers using the Gyrolab nanoliter-scale immunoassay platform and its’ impact on maximizing sensivity, performance and productivity of biomarker assays in the development of therapeutics.

Program Agenda

Introduction to Gyros and Gyrolab automated nanoliter-scale immunoassay platform.
Use of Gyrolab platform for biomarkers

A Timely Little 2-Step: How To Dance Around Lower Affinity Antibodies on Your Gyrolab™xP System
Diane M. Hamlin Investigative Toxicology,Eli Lilly, Indianapolis, IN

Abstract:
The Gyrolab™ system is a valuable immunoassay platform for the rapid development and validation of accurate, precise, robust and transferrable custom-developed assays for novel biomarkers to support early safety and efficacy assessment in preclinical drug development. However, as with other immunoassay platforms that have “wash” steps, lower affinity antibody reagents are not optimal in a standard 3-step Gyros™ Wizard method, causing a loss of assay sensitivity and/or precision. For a custom-developed rat IL1b inflammation biomarker assay, this limitation was overcome by modifying the standard 3-step (“antibody-sandwich”) Gyros™ method to incorporate a preincubation step; resulting in >7-fold increase in assay sensitivity. The modified rat IL1b Gyros™ assay was then successfully transferred and validated at an external laboratory (Contract Research Organization (CRO)). The presentation will also highlight the benefit of using the 3D and 2D images in the Gyros™ software for assay trouble-shooting, optimization of a 2-step method and the use of biological samples to verify antibody selectivity/specificity.

Novel Rat Kidney Injury Biomarker Assays Using a Gyros Nanotechnology Platform
Wei Zheng, M.S. Ph.D., Director, Research & Development, Bioscience, EMD Millipore

Speakers:

Diane Hamlin
Eli Lilly, Investigative Toxicology

Wei Zheng, M.S. Ph.D.
Director, Research & Development
EMD Millipore, Bioscience

Moderator:

Robert A. Durham PhD
Director of Field Applications, North America
Gyros US, Inc.

View Recording

Automating Pharmacokinetic Bioanalysis at Nanoliter-Scale: Strategies for Development, Validation and Transfer

This is a recording from March 18, 2014

Hosted by Cambridge Healthtech Institute

SPEAKERS:
Detection of human IgG matrices: A universal approach
The new ‘Universal’ Gyrolab platform is designed to detect human immunoglobulin G (IgG) in any animal matrix to provide Pharmacokinetic (PK) data. This is enabled by the use of an inimitable ‘Universal’ capture reagent which does not cross-react with serum from mouse, rat, and the non-human primates marmoset, rhesus macaque, cynomolgus monkey and baboon, making it an ideal reagent for the use up to and including Dose Range Finding (DRF) studies. This ‘Universal’ capture reagent greatly reduces turn around time by eliminating a significant capture reagent screen step in method development.

Sufyan Maqbool, Associate Scientist I, Clinical Pharmacology and DMPK, MedImmune Cambridge UK

Transfer and validation of a Gyrolab PK assay to a CRO
With increasing pressure to develop high quality, fit for purpose assays within reduced periods of time, smaller companies with limited internal resources need to establish partnerships with other bioanalytical groups who have a proven track record in assay development and validation activities. At NovImmune, a process has been established to perform tool selection and development in-house and then to transfer the assay to a CRO for validation and clinical sample testing. The choice of CRO is based upon multiple criteria including expertise, availability of new technologies, cost and timelines. Herein is described the process of successful transfer and validation of a monoclonal antibody (mAb) PK Gyrolab assay from NovImmune (Geneva, Switzerland) to a CRO and the use of the Gyrolab Viewer software module for its support aspect during validation.

Emilie Escoffier, MSc Biochemistry & Biotechnology, Research Assistant, Exploratory Science and,Translational Medicine, NovImmune SA, Geneva, Switzerland

View Recording

Automated Pharmacokinetic Bioanalysis at Nanoliter-Scale: From Early Stage Development to Validation and Transfer for Clinical Studies

This is a recording from January 30, 2013

Presenters:
Vimal Patel, Senior Associate Scientist, Amgen, Thousand Oaks, CA, USA
Jo Goodman, Senior R&D Manager, MedImmune, Cambridge, UK
Shawn Fernando, Senior Researcher, Bioanalytical Development, Morphotek, Exton, PA, USA

Moderator:
Robert Durham, Ph.D., Manager, Field Application Scientists, North America, Gyros, Inc.

Pharmacokinetic (PK) bioanalysis presents challenges at all stages of development for the safety and efficacy of biologics. Early in development, there is a need to support multiple candidates and multiple programs. In regulated bioanalysis, more robust methods with higher throughput are essential for decisions in advancing project timelines. Application of the Gyros technology platform for PK bioanalysis provides versatility and flexibility at all stages in an automated, nanoliter-scale format. The webinar focuses on the implementation of the Gyrolab workstation for automated PK bioanalysis in support of early stage development, regulated bioanalysis and clinical trials.

View Recording

Minimizing Repeats and Making Rapid Data Driven Decisions using Automated Nanoliter-scale Immunoassays for Impurity Testing in Bioprocess and Production

This is a recording from November 15, 2012

This webinar was hosted by Cambridge Healthtech Institute on November 15, 2012.

Presenters:
Martha L. Jackson, Senior Research Scientist, Pfizer Inc.
Jun Hyuk Heo, Biochemist, Biotechnology New and Enabling Technologies (BNET), Merck & Co

Process related impurity testing and titer determination in bioprocess and production are critical parameters that require rapid turn-around time to results and broad dynamic ranges. Host cell protein impurities are often subject to repeat testing with assays in the production of therapeutic antibodies that has created a situation in which impurity testing (e.g. host cell proteins) can often become a rate limiting step in downstream processing. With an ever-increasing portfolio to support, analytical groups need alternatives to traditional immunoanalytical methods to supply decision making data in a timely fashion. This webinar will focus on the use of automated, nanoliter-scale flow-through technology to address a critical need for improved speed, throughput and reduced repeats in process related impurity testing particularly.

View Recording

Fit for Purpose Biomarker Assay Development and Evaluation using Automated Nanoliter-Scale Immunoassays

This is a recording from May 30, 2012

This webinar was hosted by Cambridge Healthtech Institute on May 30, 2012.

Biomarker assays in the development of therapeutics is often challenged with limited sample volumes, slow assay development and need for high quality data to support bioanalysis from discovery to clinical trials.Please join scientists from Pfizer, Radix Biosolutions, and Ablynx nv as we explore the latest developments in fit-for-purpose determinations of biomarkers using the Gyrolab™ nanoliter-scale immunoassay platform and its' impact on maximizing performance and productivity of ligand binding biomarker assays in the clinical development of therapeutics.

View Recording

A Single Mouse Approach: PK and PD Bioanalysis using the Gyrolab xP Immunoassay Platform

This is a recording from March 21, 2012

This webinar was hosted by Cambridge Healthtech Institute on March 21, 2012.

Drug metabolism and pharmacokinetic (DMPK) studies in support of drug candidate selection or regulatory submission are often challenged with limited volumes required to run bioanalysis.

Ann-Charlott Steffen, AstraZeneca, Mark Cameron, Andreea Halford, MPI Research and Gyros' scientists explore the latest developments of a single mouse approach in PK/PD bioanalysis using an automated nanoliter-scale immunoassay platform and its impact on redefining performance and productivity of ligand binding assays in the clinical development of biotherapeutics.

View Recording