Véronica, living with epilepsy

FORTIER Jean-Etienne – KM Specialist

VERMYLEN Valérie – Director KM

RULIER Eric - Senior Project Leader Lab Systems

JONE Carl - HD of Analytical Dev Bio

BERNARD Alain - VP Gov Prioritization Scientific

Liaison

Big Data to

Design Quality

Practical approach in

Pharmaceutical Industry

Apr 2013

Congrès BIG DATA PARIS , édition 2013

03-04 avril 2013

Plan

What is Quality by design?

SPDM Project

• Problem Statement

• Project Methodology

• Team and roles

• Project data sources

• Data model structure

• Gain on process / product knowledge

Project future in UCB

2

What is Quality by Design?

3

Quality by Design means :

” Designing and developing manufacturing

Processes during the product development

stage to consistently ensure a predefined

quality at the end of the manufacturing process.”

Quality cannot be tested on products but should be built-in

from its design according to a predefined quality profile.

FDA, Pharmaceutical Quality for the 21st Century A Risk-Based Approach, 1997

What is Quality by Design?

QbD steps, as followed at UCB

4

Technical

Operation Development

Clinical Technical

Operation

Manufacturing /

CMO Mngt

Regulatory

Affairs

Research Quality

Assurance Risk Mngt expert

Quality by Design deployment at UCB

5

QbD

Technologic

Training and skills

Methodology

Organization

PAT

High Res Control

Data Mngnt

Statistics

Sciences Sharing

Workshop

Team

Roles and Resp.

Scope / MDM

Automation W

hat?

Why?

How? W

ho

?

We can significantly improve our quality system

by confront variability of our process to patients

biological information.

Does process parameters, product or material

quality profile settings able to satisfy UCB

patient needs

Can we correlate drug efficacy, adverse

event rise with quality or process change

Problem Statement

6

Cell / RawMat API Product Patient

Project Methodology

7

Scope defintion

Analytics need

definition

Process Steps /

"universe" link

Parameters definition

Data Identification

Process Structure

Model

Data analysis and user training

Question Answer

Team roles

8

Technical

Laboratory scientist

Team Leader

CMO Managers

Clinical

Supply managers

Program responsible

Clinician

Information technology

Solution experts

Data architects

Databases experts

Knowledge Management

Sponsorship

Project Manager

Data Scientist

Statistician

Project data sources

Process as defined in the project

9

Cell

thaw Cell

expansion

Downstream

Process

Drug product Clinical Kit Patient

Purification Filling vial Shipment /

pooling Clin. obs Bioreaction

Upstream Process

External company

Project data sources

Current Status: Disparity of data source and format

10

Cell

thaw Cell

expansion

Downstream

Process

Drug product Clinical Kit Patient

Purification Filling vial Shipment /

pooling Clin. obs Bioreaction

Upstream Process

Project data sources

11

3 SCALES

500 parameters 100 batches

4 Sources

format

3 Manuf.

sites

More than

35 Sources tables

PILOT

500.000 Data

Data model Structure

12

Site A - Lab

Site B - Pilot Site B - Large Sources

Site A - Large Site A - Clinical

Unstructured data

Structured data

Data Semi-structured data Unstructured data

Table Doc

Oracle Table import Table views

Traceability

interpretation

Single

measurement Time related

measurement

Stability

measurement

E.T.L

Analytics

system

Cross-step Multi-format Multi-domain

Throughout year historian

Electronic manual

capture

Analysis and correlation from disparate

business domain (and datasource)

Gain on process / product knowledge

13

Analysis and correlation across steps,

organization or geographic site

Work with disparate format of sources

First step in massive data capture and

perpetuation.

Detection of minor process effect

change on product quality.

Cyclic variation detected earlier.

Multi-format

Multi-domain

Throughout year

historian

Cross-step

Project future in UCB

14

5.000 Parameters

per process

10.000 batches

more Databases connected

(SAP, Historian, etc.)

30 Manuf. sites

More than

50.000.000.000 Data

More than

less Part of unstructured

data as Excel

Real time analyzers

Project future in UCB

15

Project future in UCB

16 © UCB Pharma, S.A, 2013. All rights reserved

Questions?

17