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BioXpert Training

Course

Room C 203
2nd Floor
Chemical Eng & Advanced Materials

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BioXpert Overview

Ronan O’Kennedy

BioXpert Course June 2010

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SCADA Advantages
• Supervisory Control And Data Acquisition

• Continuously collects & stores real time process data


– Batch to batch comparisons
– Real time process diagnostic

• Provides higher level process control through sequences


– Automating phase transitions
– Temp Step-Up, Inducer feeding
– Bolus nutrient feeds & Fed batch profiles

• View process remotely (and make changes!)

• More recent systems implement ISA88/95 philosophy


– Consistent model for process descriptions
– Hierarchical & Extensible Process view

• Can provide Recipe Management


– Consistent bioreactor set up and performance
– Remote Log Bioreactor configuration

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Adapting Configurations : Applications
• Batch • Benchtop • Microbial
• Fed batch • Disposable • S. cerevisiae
• Continuous • SIP • P. pastoris
• Perfusion
• Mammalian
• 2 stage cell
Phases Additional Sensors
• Inducer feeds • Exit Gas analysis
• Bolus nutrient feeds • Cell Density
• Fed batch • dCO2
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Design Considerations
• Physical Layout

• Unit procedure Metadata needs


– Unit procedure naming convention, Batch geneology, Raw materials,
– Unique batch names
• Online variables + extras

• Offline variables

• Formulas & Derived variables

• User Training
Consistent file naming conventions

• Procedures for data management (saving)


– Can procedures be automated ?

• Data hygiene & analysis methods


– How much time will be spent on this ?
– Can methods be automated ?
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ISA88 Design Philosophy

PHYSICAL MODEL • Process design philosophy


ENTERPRISE

May contain

SITE

PROCEDURAL
AREA
May contain
• Developed initially as
CONTROL MODEL

PROCEDURE PROCESS CELL


May contain
software design standard
Consists of an May contain
ordered set of

UNIT PROCEDURE UNIT


Consists of an

• Models & terminology for


May contain
ordered set of

OPERATION EQUIPMENT MODULE


Consists of an

structuring production
ordered set of May contain

PHASE CONTROL MODULE

processes
From Menendez & Tanner (2007)
Pharma Eng 27(2) pp 1

• Models for developing


equipment control
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BioExpert 2 with ADI 1030 & 1010

• Example “SCADA”
– Not ISA 88 compliant but can be configured to be close analogy
• Cannot upload configuration to Controller*
– Think
• Current & Future uses
• Expansion (Multi vessel & lab)
• New capabilities
• Managing “Recipes” and Protocols
• Backup

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Experimental Cycle
Planning Setup Execution Analysis

• Aims • Probe checks • Offline data • Quality samples


• Set up templates • Equipment set up record • Compile offline &
• Raw materials & • Revival record • Stored samples Online data
consumables • Inoculum record record • Derived
• Passage record • Passage record calculations
• Media batch • Update overview
• Run Notes/ record & data
deviations/proble check
ms • Analysis

Record batch to batch traceability (Excel File)

• Identify common traits & differences required at dev each step


to simplify subsequent analysis & comparison
– Config & Templates take into account as many possible
combinations
– Think of how you will want to analyse data
– This may take a few iterations !

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Physical Arrangement
• Two areas
– Small Scale
– Pilot Scale

Process Cell =R101 • 8 bioreactor per area


COM port4

Units =
B002L01-> B002L08 • Folder for each bioreactor
\R101\

• Pilot lab has mixture of


benchtops,SIP &
disposable
\\OFFICE-Share\

• Consistent naming code


Process Cell =R201
– B = Benchtop
COM port4
– S = SIP
Units =
– D = Disposable
B002L09->B002L12
B005L01,S020L01, • Back up frequently !!
\R201\ S070L01,D250L01 10
Bioreactor / “User” Folder Naming
Conventions
• Consistent
– Across existing & planned bioreactors
– 005L01,005L02,005L03 etc

• Entensible
– Can be expanded without changes
– Subfolders are possible
• eg "C:\Program Files\BioXpert\FERM.EXE" 005L01\PERFUS -c11
0905TEMP

• Maintain some rules


– Same # of characters for folder names

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Project & Experiment
Think of the hierarchy !
Campaign & Batch Metadata
Project, Experiment
Seed Lot/ SF

Lot, SF type, incubator, cell


line, cell bank, vial, passage,
Online data Offline Data Quality data Annotations medium, protocol

Seed Lot Bioreactor

Lot, Bioreactor, source passage,


Online Data Offline Data Quality data Annotation medium, protocol, recipe

Production Lot Bioreactor

Lot, Bioreactor, source,


passage, medium, protocol,
Online Data Offline Data Quality data Annotation
recipe

Harvest

Lot, Harvest Skid, source, Filter


Online Offline Quality data Annotation type, area, protocol,recipe

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Configuration Steps
Configure Controllers

Configure & Test COMs

Configure Software Acquisition &


Variable Names

Configure Template : Constants,


Formulas, Offlines & Statements

Copy settings to other units in


structured hierarchy

Back up structure & Set up file


backup
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Summary
• Don’t depend default configurations

• Define your requirements carefully

• Consider metadata requirements

• Hierarchical structure

• Be consistent with multiple bioreactor configurations

• Consistent Data handling operations

• Consider data output requirements

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Thank You

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Backup

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BioExpert V2 : Desktop shortcuts
Target =
Desktop "C:\Program Files\BioXpert\FERM.EXE" B002L01 -c11 TEMP1
Shortcut
for each vessel
• Defines the startup data folder, .ini file &
Template file
• Template file defines offline, constants,
“User” Startup Startup
control law profiles & statements
Folder Ferm11.ini Template. frm
• You can have multiple shortcuts to a single file
bioreactor for different configs

Where X = Bioreactor number Template File


FermX.ini TEMPxxx.frm
• Defines the online, comm port ,channel, ADDA • Logging frequency
card and other serial config • Offline variables, constants
• X is the number of the ini file, not the • Substrates & products
bioreactor channel number. characteristics , formulas,
• You can have multiple ini files for a single • Formulas, Control profiles &
bioreactor with different configs Statements
• Alarms

Where “User” = Bioreactor Name


“User” Folder • Use consistent, extensible Names
• 8 Character maximum for folder, .ini & .frm file
names !!
• Make a local back up copy of all config files
• Set up scheduled data backup to network drive
(FolderClone or MS SyncToy)

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Copy settings to other units in Back up structure & Set up file
structured hierarchy backup

• Copy Ferm11 and rename


Ferm12,Ferm13,Ferm14 etc
• Create folders for each
bioreactor & copy 0905Temp
into each folder
• Copy Desktop link and rename
for each bioreactor
• Update Target in Desktop link to
point to relevant ini & folder
• Open each desktop link &
modify device number / COM
port as required

• Backup !
– Folderclone Standard
• Done !

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User Steps

• Start Bioexpert with desktop link


• Set start time & record relevant
metadata
• Name file (recommend reverse date
with initials)
• Start run, sample & analyse
• Update batch summary sheet
• Compile to shared file store / Database
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Tracking & Compiling data flow
• Maintain batch summary list • Maintain Simple Data store
– Metadata – Unique code for each Bioreactor run
– Important measurements (Qp, peak VCC etc) – Easily identified batches & main attributes
– Use excel autofilter to sift and select – Master Spreadsheet to summarise genealogy
– VLOOKUP for more complex searches – Batch comparison easily automated

COM port4

COM port4

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