Method Development Challenges, Regulatory Findings, and Innovations
in Bioanalysis

5^th Workshop on Recent Issues in Bioanalysis (5^th WRIB)

"Discussing, Reviewing, Sharing Perspectives, Providing Potential Solutions and Agreeing upon a Consistent Approach
on the Recent Issues in Bioanalysis "

April 13-14, 2011, Montreal, Canada
Short Courses: April 11-12, 2011
Hotel Marriott Chateau Champlain

Highlights | Workshop Lectures | Pre-Workshop Short Courses | Final Agenda | Sponsors

Short Course 1a: High Throughput Drug Analysis by LC-MS
8:30am - 4:30pm, April 11, 2011
Instructor: Dr. Perry Wang, US FDA

Course Description:

The introduction of combinatorial chemistry technology has significantly increased the amount of compounds generated in pharmaceutical industry. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery and development to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corresponding revolutionary improvement to the conventional methodology must happen.

High-throughput drug analysis is a new topic for drug discovery and development in the pharmaceutical industry. This one-day short course will mainly focus on the most recent significant advances of high-throughput sample preparation and drug analyses by LC/MS.

Course Outlines:

Introduction
- Overview of drug discovery and development in pharmaceutical industry
- Introduction of combinatorial chemistry
- How to deal with throughput and compliance
- Basic considerations to develop a high throughput method
- The trends of the pharmaceutical industry
- Fundamental strategies

High-throughput sample preparation
- Basic techniques of sample preparation
  - Filtration
  - Dilution and injection
  - Protein precipitation
  - Evaporation and reconstitution
  - Liquid-liquid extraction
  - Solid phase extraction: theory, practice and trouble shooting (on-line and off-line)
  - Supported Liquid Extraction (SLE)
  - Immobilized Liquid Extraction (ILE)
  - Solid Phase Micro Extraction (SPME)
  - Disposable Pipette EXtraction-DPX
- Automation for sample preparation
  - Robot liquid handlers (Hamilton, Bechman, and etc.)
  - 96-well, and 384-well
  - Bar code readers
  - Nanostream
  - Pierceable caps
  - Tube capping and uncapping
  - Fast-flow on-line extraction
  - Vacuum manifold
  - Equilibrium dialysis and ultrafiltration
  - Heating&sealing to improve extraction efficiency

High-throughput instrumentation
- Application of LC/MS
- Introduction of UPLC and UHPLC
- Introduction of Fused-Core HPLC Columns
- Column switch backwash technique and guard column regenation
- How to test and avoid ion suppression/enhancement for MS
- Parallel/staggered systems (Two or more LCs connected to one MS)
- Application of Tandem mass spectrometers
- Capillary and nano-HPLC technology
- Nano-Electrospray MS
- Introduction of monolithic chromatography
- Introduction of hydrophilic interaction liquid chromatography (HILIC)
- Some keys to develop a successful high throughput HPLC method

How to deal with the challenge of urine samples

Future direction for high-throughput sample preparation
- 1536-well format
- Monolithic separation
- Chip-based sample preparation
- Nanoelectrospray with direction injection
- Molecularly imprinted polymers

Course Topics:

Overview
- Introduction of high throughput concept to pharmaceutical industry
- Why do we need high throughput analysis
- The requirements for high throughput analysis
- Why do we use LC/MS or LC/MS/MS

How to develop a high throughput LC/MS method
- The relationship of pKa and pH
- MS analyzer selection and MS parameters optimization
- HPLC, uHPLC and UHPLC
- Solvent selection
- Introduction of nanoelectrospray technology
- Introduction of HPLC-Chip/MS system
- Introduction of multiplexing systems

High throughput sample preparation
- Protein precipitation
- Liquid-Liquid extraction
- Solid phase extraction
- Immobilized Liquid Extraction
- Introduction to Solid Phase Micro Extraction
- Disposable Pipette Extraction - DPX

Special topics
- Monolithic chromatography for high throughput analysis
- Hydrophilic interaction liquid chromatography (HILIC) for biological samples
- Ion suppression of biological samples
- How to deal with urine samples

Who Should Attend:

This one-day course will benefit the scientists ranging from college students to professionals in the fields of pharmaceutical industry and biotechnology,

5th Workshop on Recent Issues in Bioanalysis (5th WRIB)

5^th Workshop on Recent Issues in Bioanalysis (5^th WRIB)