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Automating Fermentation. Presenters. Todd Ham Automation Engineer Emerson Process Management, Life Sciences, Food, and Beverage Todd Edgington Automation Engineer Genentech NIMO Facility, Oceanside, CA. The NIMO Project Overview.

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Presentation Transcript

Presenters l.jpg
Presenters

Todd Ham

  • Automation Engineer

    Emerson Process Management, Life Sciences, Food, and Beverage

    Todd Edgington

  • Automation Engineer

    Genentech

    NIMO Facility, Oceanside, CA


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The NIMO Project Overview

  • NIMO is a large scale, multi-product biopharmaceutical complex.

  • Fermentation/Recovery process

    • Fermentation

    • Centrifuges, Chromatography, UF/DF, …

    • CIP/SIP

  • Fully automated

    • Recipe-level batch control

    • Warehouse management

    • Electronic signatures

    • Electronic records


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The NIMO Project Timeline

2000

2002

2004

2006

2008

NIMO Engineering Kick-Off

Engineering and Design

Procurement

Construction

Commissioning

Validation

BLA Enabling Runs

BLA Submission

FDA Review

BLA Approval


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NIMO Philosophy

  • Fully automated

  • Paperless, dock-to-dock

    • Electronic record

    • Handheld units for plant operations

    • Barcode scanning for material additions, filters

  • Consistency for operator / Use of industry standards

    • Bus technologies

    • S88 / S95

  • Fermentation was integral to entire project

    • Project philosophy impacted fermentation

    • Fermentation impacted project philosophy


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The Fermentation Process Overview

CIP/SIP

Feed Vessel (for Large Fermenters)

Pressure Control

Inoculation

Media

Additive

Sparge

Sampling

Base


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S88 Control Modules

  • Identify the “common” modules and instances.

Examples:

Motors

Valves


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Used some project-wide module templates

Sampling System

Sparger Control

Added some area-specific module templates

Fermentation Agitator Control

Fermentation Pressure Control

Fermentation Temperature Control

pH Control

Dissolved Oxygen Control

Foam Control

Added unique (one-time use) equipment modules

Transfer Panels

Valve Assembly (VA) Control

S88 Equipment Modules



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S88 Units

  • Identify classes and instances based on..

    • Physical similarity

    • Phases that they use

      • Batch Media

      • Inoculate

      • Ferment

      • Etc.


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Batch Feed Vessel

Batch Fermenter

Pre-inoculation Prep

Inoculate

Ferment

Sample

Add Additive

Add Base

Add Feed Media

Transfer

Pressure Test

The following CIP Phases for Feed Vessel, Production Fermenter, Seed Fermenter, Discharge Line, and Media Line

CIP Setup

CIP Circuit

CIP Complete

Pre-SIP Pressure Test Seed Fermenter

Pre-SIP Pressure Test Production Fermenter

Pre-SIP Setup

SIP Sample Line

SIP Production Fermenter

SIP Inoculation Line

Phase Control


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Recipes

  • Group Phases into Operations

  • Group Operations into Unit Procedures

  • Group Unit Procedures into Procedures


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Vessel to Vessel Communication

Are you ready to receive?

Here comes the transfer.

Yes. Bring it on.

I got it.


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MAT 2.

200 GR

Manufacturing Procedures

  • Material Management

  • Container Management

  • Filter Management

  • Sampling


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Testing

  • Emerson and Genentech worked together closely on requirements

  • Emerson performed module-level and integration–level testing

  • Emerson and Genentech ran a full Customer Acceptance Test (CAT) prior to delivery


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Lessons Learned – Modularity

  • As much as possible, keep process units the same.

  • With similar units, make sure operations are as uniform as possible as well!

  • Beware of alias over-load.

  • Enforcement of classes can be a negative thing.


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Lessons Learned – Level of Automation

  • High levels of automation are a double edged sword.

  • With high levels of automation and modularity, documents can become very numerous.


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Lessons Learned – Up-Front Testing

  • Time spent upfront saves on back end effort.

  • Easier to fix problems off-site when you are in control of the software.

  • Risk based software validation works.

  • No level of testing will capture all mistakes or prevent changes.


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Lessons Learned – Raw Material Handling and other Manufacturing Procedures

  • Make sure everyone is on the same page from the start.

  • Make sure everyone uses the same language.

  • Get operators time on the equipment.


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Conclusion Manufacturing Procedures

  • Leverage the S88 model as much as possible.

  • Take as much time as possible upfront.

  • Prepare for an effort commensurate with your level of automation.

Right-Size


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Acknowledgements Manufacturing Procedures

Genentech

  • Johannes Roebers

  • Christoph Lebl

  • Dave Stewart

  • Sean Stephan

  • Debi Marshall

  • Christopher Birnie

  • Leonidas Castaneda

  • Jim Merrit

  • Dirk Ellison

  • Emerson

  • Christie Deitz

  • Craig Bieda

  • Brian Crandall

  • Molly Firkins

  • Dick Seeman

  • Chen Yang

  • Shelley Richards

  • Ajay Savargaonkar

  • Ketaki Raste