Pharma&Biotech

Lonza Wayne Inc., Wayne, PA 19087 / February 2014© Lonza

The Integrated Sample Lifecycle: Automating Devices,

Media and Monitoring Systems with MODA™

Webinar: 11 February 2014

Speaker: Michael Goetter

Director of Lonza Bioscience Informatics

Pharma&Biotech

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Jan-14

Today’s Presenter

Michael Goetter, Director of Informatics

Lonza Pharma&Biotech – Bioscience Solutions

10+ years IT Consulting (IT strategy, custom software

development and systems integration)

10 years Quality Systems and Informatics (quality

control and biopharmaceutical quality systems)

Venture capital due diligence and consulting for early

stage IT ventures

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Jan-14

Forward Looking Statements

Certain matters discussed in this presentation may constitute forward-looking statements.

These statements are based on current expectations and estimates of Lonza Group Ltd,

although Lonza Group Ltd can give no assurance that these expectations and estimates

will be achieved. Investors are cautioned that all forward-looking statements involve risks

and

Uncertainty and are qualified in their entirety. The actual results may differ materially in

the future from the forward-looking statements included in this presentation due to various

factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any

intention or obligation to update the statements contained in this presentation.

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Jan-14

Agenda

Lonza and Bioscience Informatics Overview

Common compliance and clerical issues

Why “paperless lab” is not enough

How MODA™ manages complete sample lifecycle information

Making the right integration choices with limited time and budget

Compliance, time-saving and information intelligence benefits

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Jan-14

Lonza Overview

Trusted supplier to the pharmaceutical, biotech and

specialty ingredients markets

Founded in 1897 with headquarters now in Basel, Switzerland

Sales of about CHF 3.6 billion in 2013

Global operations:

Located in more than 40 major sites

Employs approximately 10,000 people

Global leader in microbial control and custom manufacturing:

Hygiene

Water treatment

Active pharmaceutical ingredients, both chemical and biological

Cell therapy

Leading positions in product market niches:

Endotoxin detection

Cell-based research products

Nutrition ingredients

Performance intermediates

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Jan-14

WinKQCL™ 5 Software

WinKQCL™ 5: Enterprise-class Endotoxin Analysis Software

Best-of-breed data management platform for endotoxin testing and analysis

Support for many industry-leading readers

Comprehensive ad hoc test analytics and reporting suite

Enterprise Support for multi-site management and collaboration over a global

network

Integration to third party systems (e.g. MODA™, LIMS, LIS)

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Jan-14

MODA-EM™ – QC Microbiology Software

More Science. Less Paper.

Purpose-built QC Microbiology platform

Quickly move from paper-intensive QC

monitoring/analysis

Measurable gains in operational efficiency,

improved quality, reduced costs

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Jan-14

QC Micro Compliance and Deviation Challenges

Data Entry and Data Review

Manual, paper based process using controlled paper

Long cycle time for data review

Multi-step, redundant data approval process via LIMS

Approve Sample, Test and Record

Data Reconciliation

Data is generated and maintained in multiple locations, which makes

mining that information for reports and investigations a difficult task

Manual reconciliation of samples to paperwork requires multiple steps

Trend Report Generation – Extensive data checking required to

assure all samples are included in quarterly reports

Compliance to SOP’s not enforced: calibration, media expiration,

incubation times, etc.

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Jan-14

Laboratory Workflow

Typical Sample Lifecycle

Process Step is Non-Value Add

Process Step is Non-Value Add but Required

Process Step is Value Add

Why “Paperless Lab” Is Not Enough

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Which One Is a “Paperless” System?

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Jan-14

Answer: Both!!

(Only System #1 has more paperwork deviations….)

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Jan-14

QC Micro Integration Points… And Where

They End Up…

Laboratory Management Sample Records Spreadsheets

Disparate Data Points Air, Surface, Water Media Equipment Personnel

“Islands” of Information

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Jan-14

LIMS and ELN Gaps – Paperless for QC Micro?

Typically product and chemistry-centric testing model

Trending and limits limited to batch and product

Integration focused on batch imports of lab devices

No simple answer to the variability of personnel monitoring and

organism identification/trending

LIMS and often ELN data entry starts in the lab

High QC micro sample volume requires automation in the production

area (aseptic typically ranges from 105 to 106 samples per year)

High QC Micro sample volume requires workflow models which

process multiple sample and sample types at one time

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The QC “Big Picture” – Beyond the Lab

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Jan-14

QC Micro Requirements in the Sample Lifecycle

Plan

Capture and confirm samples were taken where and when they are

scheduled

Prevent missed samples

Track the product and batch number being produced during monitoring

Collect

Track samples from point of collection to lab

Confirm use of correct media, within expiry, and track lot number

Collect information about viable and particulate air quality and other

environmental indicators during operation

Track the personnel in the room and their microbial status

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Jan-14

QC Micro Requirements in the Sample Lifecycle

Process

Confirm sample receipt in the lab

Collect data about and from equipment used in testing

Track sample through lab processing and results

Confirm equipment and media used is in conformance with SOP (ex.- incubation

times)

Capture results quickly and accurately

Evaluate and alert for critical events (ex.- over alert and action limits, critical

organisms)

Review and Analyze

Rule out invalid and false positive results: review details of every step in the sample

lifecycle and what was used in the process

Report and trend details quickly and accurately by location, classification, personnel,

organisms, product, etc.

Conduct investigations and excursions quickly, accurately and with access to

comprehensive information

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Jan-14

Why Pursue Sample Lifecycle Integration?

Reduce human intervention

Reduce human error

Prove accuracy of data

Prove compliance with SOPs

Improve availability/comprehensiveness of data

Eliminate data aggregation and manual analysis

Eliminate non-value added sample lifecycle steps/labor

Reduce time between decision to take a sample and decision to

act on the data!!

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Jan-14

Integrated Sample Lifecycle – The Outcome

Elimination of

17 NVA’s.

Prepare Sample

Bottles, Media

and Equipment

Travel to Sample

Location

Sample EM /

WaterDeliver to Lab

Water / EMRead Plates

Test BB

Test CON / TOC /

LAL / COL / EP

Incubate PlatesRead Plates

Excursion

YES/NO

Approve Data

Perform

Investigation

EM

WATER

NO

YES

Incubate Plates

How MODA™ Integrates, Analyzes and

Centralizes Sample Lifecycle Information

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Jan-14

MODA-EM™ –

An Integrated Solution for QC Micro

Improved Compliance Increased Productivity Expedited Decision Making

Paperless, Automated Sample Lifecycle

MODA™ Solution Components

Mobile Data Acquisition

Flexible Workflow

Integration

On-Demand Analytics

Systems (ERP, LIMS, CAPA)

Devices

Media

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Jan-14

Plan and Collect – Mobile Data Acquisition

Mobile computing platform for field data capture in

clean room areas:

Offline sampling and data synchronization

Stainless steel cart

Ergonomic tablet PC

Docking station

Thermal label printer

Barcode scanner gun

Proximity reader for

RF badges

Space for equipment

Space for growth media

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Jan-14

Plan and Collect –

MODA™ Integration Capabilities

Batch or ERP system submits product and lot data and triggers monitoring plan

Barcoded locations and ports confirm correct routine is followed

Automatic sample submission upon collection – mobile platform submits sample data

when sample is taken

SOPs can be viewed electronically from document management systems

Media qualification check – pre-barcoded media automatically confirms correct type, lot,

expiration date and growth promotion status

Portable particle counters are run from MODA™ mobile platform, collect particulate

results, and send data directly to MODA™

Personnel IDs are scanned and matched for glove and gown monitoring

Continuous monitoring systems send data to MODA™ about particulates, temperature,

humidity, etc.

Online TOC and Conductivity meters capture results at water port

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Process –

Scan and Track Samples Through the Lab

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Jan-14

Process –

MODA™ Integration Capabilities

Sample tracking – pre-barcoded media or barcode labels link the physical sample to

the electronic record and next step in testing process

Group barcodes are created and scanned to track similar samples quickly and

accurately

Testing consumables and equipment are scanned, tracked and qualified for use, in

accordance with SOP

Incubators are scanned, confirming temperature placement and time-tracking

Sample labels or pre-barcoded media are scanned, presenting correct results entry,

checking limits and automatically entering negative results

Results from LAL Software (ex.- WinKQCL™), TOC and Conductivity meters are

imported directly into MODA and matched with samples

Results from Organism ID and Rapid Micro systems provide results and complete

organism information directly to MODA™, matching assay with samples

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Review and Analyze

Track and trend by location, room, sampling site, person, organism,

product batch/lot and any combination

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Review and Analyze

Visualization – Trend and correlate environment, process (i.e. water

loop), across multiple tests over specified dates

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Jan-14

Review and Analyze –

MODA™ Integration Results

Approved EM and Water Results, deviations are sent to LIMS or ERP system submits

product and lot data and triggers monitoring plan

Organism identifications and supporting data are trended with results

Personnel are trended and scored for aseptic qualification

Notifications provide timely alerts for critical events and adverse trends

Continuous monitoring systems send data to MODA™ about particulates,

temperature, humidity, etc.

Data marts and flexible integration methods aggregate data from integrated media,

devices, and systems to apply detailed analytics for all aspects of QC Micro Monitoring

(ex.- CMS)

Dynamic, Visual Maps show results and allow drill-down into hotspots for Rooms and

Water Loops for investigations, CAPA and root cause analysis

Formal Reports and Ad Hoc Trends are generated quickly, flexibly and accurately

across all MODA™ data for excursion support and routine reporting

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Integration Methods

Integration Method Description Typical Purpose

Web Service API A service-oriented

architecture API

consisting of a series of

standard web service

method calls

• LIMS or ERP systems for batch scheduling,

batch reporting, product/raw materials tests

and consumables mgmt.

• Calibration Mgmt. Systems for equip.

maintenance

• Continuous Monitoring Systems for

particulate results per batch

File Import/Export Import or export data

to/from MODA from csv

or xml files (Excel

supported)

• Import of sample information from

spreadsheets

• Import of initial configuration information

• Import of TOC and LAL results

• Export of samples/results to Excel

• Export of samples/results to LIMS

(scheduled import)

• Export of samples/results to SPC tools

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Jan-14

Integration Methods

Integration Method Description Typical Purpose

Direct to Database Reporting views and

stored procedures

which can be called

directly from the

database (with

permissions)

• Access to enterprise reporting tools (ex.-

SAP Business Objects)

• LIMS integration (transactional)

• SPC tool integration (views)

Device Framework RS-232 and modbus

supported interfaces

with configurable data

mapping

• Particle counters

• Organism identification systems

Workflow API Stored procedure

framework for adding

event-based workflow

options and redirection

during the sample

lifecycle

• Complex test methods

• Special or external system notifications

• Special compliance steps

• Other system integration (ex.- Trackwise)

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Jan-14

MODA™ Integration Examples

SPC tool

accesses

reporting views

for analysis Data

bas

e

LIMS/ERP

Pushes batch

number and

schedule

CMS sends

batch

particulate

results for

processing

We

b S

erv

ice

AP

I

Workflow API

manages

complex test

methods

User starts

particle counter

and acquires

readings Devic

e

Fra

me

wo

rk

User imports

sample data

from Excel

User imports

results from

LAL/TOC

devices

File

Im

po

rt/

Ex

po

rt

LIMS/ERP

calls batch:

• Summary

• Deviations

• All results

Plan Collect Process Review & Analyze

User exports

results from

Analyze in

Office XML

(Excel)

Integration Choices and Expected Benefits

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Jan-14

Evaluating Your Integration Options

Cost Considerations Benefit Measurements

• Initial installation and development

• Validation

• Data migration

• Ongoing support

• Additional equipment/ consumable costs

• Compliance/regulatory qualification

• Net time impact (new vs. old process)

• Proof of SOP conformance

• Error-rates of results

• Number of process deviations

• Labor hours saved

• Volume of samples affected

• Criticality of process/test

• Investigation/excursion time

• Quality and speed of reporting and CAPA

Like any business decision, choosing what parts of the sample lifecycle to

integrate and when is a function of cost vs. benefit measured in:

Time, Compliance and Money

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Jan-14

Example: Sample Collection

LIMS + Paper 8 hours

– Paperless 4 Hours

= Savings 4 Hours

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Example: Non-Viable Air Sampling – Before

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Example: Non-Viable Air Sampling – After

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Measuring the Benefits –

Labor Savings Example

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Measuring the Benefits –

FTE Analysis Example

Projected Year 1

Headcount

Impact = x FTE’s

Overall Savings of

2x FTE’s

to double sampling

volume.

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Jan-14

Measuring the Benefits – ROI Example

Payback Period =

x Months

5 Year Savings =

$y MM

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Jan-14

Conclusions

QC Micro organizations face unique challenges managing data

throughout the sample lifecycle that are distinct and different from

product testing

Many traditional “paperless lab” solutions continue to focus on

chemistry and/or limit their scope to the workflow within the lab

Truly “Paperless” for QC Micro requires looking beyond the lab for

integration of many data points throughout the sample lifecycle

MODA™ provides a purpose-built platform that integrates sample

information with devices, systems, people and consumables to provide

a comprehensive view of QC Micro

An effective integration approach focuses on optimizing the sample

lifecycle with measurable time, cost and compliance benefits

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Jan-14

Upcoming MODA™ Product Releases

MODA-EM™ Version 3.2 – Coming Soon!

New calendar and scheduling interface and features

New reporting and trending features

Improved device interfaces for non-viables, LAL and TOC

Many new out-of-box device integrations- Organism ID, online TOC,

conductivity meters, etc.

MODA-EM™ Version 4.0 – In Development

Comprehensive, configurable workflow engine

New features for QC and bio-processing production EBR

Major new analytics and trending features

Web browser and tablet user interface

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Jan-14

Questions & Answers

To submit a question, please use the “Questions” feature located

in your control panel, which you can access by clicking on the

orange arrow on the right hand side of your screen.

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Jan-14

Wrap-up: More Information

Mike Goetter

Director of Informatics

Email: michael.goetter@lonza.com

Learn more about MODA™:

www.lonza.com/moda

Or via email: moda@lonza.com

Thank You!