Driving Productivity in Analytical Workflows for Biotherapeutic Development Removing Inefficiencies from Routine Analysis

Agilent Technologies June 5, 2015

1

A Brief History of Agilent

2

Our journey so far

1939–1998: The Hewlett-Packard years 60-year heritage of leadership and innovation

1999: Agilent is born Biggest IPO in Silicon Valley: $2.1 billion

2005: The new Agilent Focus on measurement

2006–2010: Transformation Acquisitions, divestitures and restructuring

2013: The world’s premier measurement company $6.8 billion revenue

2013: Agilent announces separation Expected to be two companies in early November 2014

November 21, 2013

•  Spin-off to create two companies with greater strategic and customer focus, each well positioned in its sector

•  August 1: Keysight begins operating under its own name (as Agilent subsidiary) in most countries

•  Early November: Keysight is publicly traded and independent from Agilent

Agilent to Split into Two Companies Strategic Rationale for Separation

June 9, 2014

3

The New Agilent

4

Complete Focus on Life Science Measurement

•  Pharma & biotech •  Academia & government research •  Food •  Environmental & forensics •  Chemical & energy •  Anatomic pathology •  Molecular diagnostics

The New Agilent

November 21, 2013

Big Pharma – becoming Big Biopharma

June 9, 2014

Confidentiality Label

5

June 9, 2014

Confidentiality Label

6

Biologics manufacturing is highly complex & requires analysis at every step

June 9, 2014

Confidentiality Label

7

Market Manufacturing

Centrifuge

Pre-clinical Clinical

Biomarker ID & validation

DNA Vector

HT Clone Screening & Selection

Chromatography Column #1

Chromatography Column #2

Chromatography Column #3

mAb Generation Platform

e.g. transgenic mice

Cell Culture Scale-up & Production

Downstream Processing & Purification Formulation

Human gene

Establishment of genetically engineered cells (e.g. CHO) that produce desired product

“the process is the product”

June 9, 2014

Confidentiality Label

8

Market Manufacturing

QA/QC Centrifuge

Pre-clinical Clinical

Biomarker ID & validation

DNA Vector

HT Clone Screening & Selection

Chromatography Column #1

Chromatography Column #2

Chromatography Column #3

mAb Generation Platform

e.g. transgenic mice

Analytical Groups Develop analytical methods; analyze samples from other functions, methods transfer

Cell Culture Scale-up & Production

Downstream Processing & Purification Formulation

Methods

Samples

Samples Samples

Samples

Samples Samples

Human gene

Analytical groups are tasked with methods development, sample analysis & methods transfer

Establishment of genetically engineered cells (e.g. CHO) that produce desired product

Solutions for Biopharmaceutical Development From sample to answer

June 9, 2014 Agilent Confidential

9

Separation Sample Preparation Analysis

Agenda Time Speaker Title

08:30-9:00 Registration and Breakfast

9:00-9:15 Randy Bolger Agilent

Welcome & Introduction

9:15-10:00 Gurmil Gendeh Agilent

Addressing Analytical Challenges in the Characterization & QC of Biotherapeutic, Biosimilars, and ADC’s

10:00-10:45 Tim Rice Agilent

Employing Intelligent Strategies to Increase Speed, Throughput and Productivity of UHPLC Analytical Methods for Biotherapeutic Development

10:45-11:00 Break

11:00-11:30 Randy Bolger Agilent

Removing Inefficiencies and Variability from Peptide Mapping and glycan Analysis Sample Preparation for Biotherapeutic Development

11:30-12:00 Peter Bryngelson Biogen Idec

High-throughput Protein Quantitation from Cell Culture Using a Heavy Isotope-labeled Internal Standard

12:00-12:30 Lunch

12:30-1:15 Eric Kuhn The Broad Inst.

Developing Automated Affinity Enrichment Workflows for Multiplexed Peptide Assays using the AssayMAP Bravo Platform

1:15-2:00 Dawn Stickle Agilent

Advantages of Open Access and Walkup LC/MS Supporting Drug Discovery and Development

2:00-2:15 Break

2:15-3:00 Gurmil Gendeh Agilent

Practical Application of HPLC-Chip and CE in Analytical Characterization of Biotherapeutics