biopharmaceutical facility of the future presentation march 2010 final version
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Biologics Manufacturing Facilities of the FutureDesign Trends for Facilities in 2020
By Andy RaynerGroup Director of Technology, PM Group
18th March 2010
BioLogic Manufacturing World Asia 2010
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Cell Culture Facilities global capacity being driven by mAb’s & Vaccines:
Product Trends
Source: Phrma 2008 Biotech Report
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Facilities of Today
Small Scale <5,000L
Medium to Large Scale 5,000L – 10,000L
Large to Very Large Scale 10,000L – 25,000L
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The Visual Factory
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Superskids
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In Line Dilution & Formulation
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Sustainable Design Methodologies
Innovation SustainableSites
WaterEfficiency
Energy &Atmosphere
Materials &Resources
IndoorEnvironmental
Quality
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A number of product trends are impacting facility design most notably:Higher Titres
Product Trends
PER.C6® Cell Line FROM CRUCELL Titres up to 27 g/L
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Regulatory Trends
1978
Introduction of GMPs
Introduction of Validation
1987
1997
2003
Post approval changes to biologics processes
Multiproduct manufacturing
Transfer of many
biologics to CDER
2008
The age of Biosimilars
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Yesterday
Tomorrow
Open vs Closed Processing & Multiproduct Operation
Today
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The Rise of Disposables (Single Use Equipment)
Source: Based upon initial concept by Jagschies, GE Healthcare, Bioprocess International 2007
10L
100L
1,000L
10,000L
10Kg 100Kg 1,000Kg
25,000L
100,000L
3,000Kg
2,000L
Fully Dedicated Facilites(500Kg to 3,000Kg)
Concurrent Multi-Product Facilites (10Kg to 1000Kg)
Clinical Production Facilites(2Kg to 30Kg)
Stainless Steel Envelope
Disposables Envelope
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Traditional Manufacturing Schematic
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Buffer Hold
Buffer PrepMedia Prep
Single-UsePrep
System
BufferHold Totes
Single-UsePrep
System
`
Kim L. Nelson, Ph.D. 2006
L1
L2
L3
Seed Trains
NutrientFeeds
Clarification
VirusInactivation
ToFill /
Finish
0.22filtration
Seed Biorxt
Seed Biorxt
5,000 L Bioreactor
BreakTank
Production
HarvestTank
InactivationHold Tank Harvest
Tank
Chrom 1CIP Skid
CellInoc
Purification
UF / DFChrom 3
HarvestTank Harvest
TankHarvest
Tank
Chrom 2
Viralnanofiltration
UF / DF
CIP Skid
CIP Skid
```
```
```
```
First Stage Disposables Implementation
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Available Available –– Good ApplicationGood ApplicationAvailable. but must confirm process suitabilityAvailable. but must confirm process suitability
Available. but must confirm process suitabilityAvailable. but must confirm process suitabilityUnavailable at larger scalesUnavailable at larger scales
Second Stage Disposables Implementation
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Single Use Equipment– Liquid Storage and Mixing
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Single Use Equipment– Bioreactors, Harvest and Downstream
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Reduced cleanroom floor space allocation
Space Requirements For Single Use
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Reasons to Consider Disposables
Technical- Product Changover Time- Flexibility to change- Campaign Turnaround Times- Water Usage / Waste Water- Solid Waste Disposal- Leechable/Extractable Validation- Facility Size- CIP- SIP- Sustainability design
Capital Cost & Cost of Goods USA/Europe Asia USA/Europe Asia- Equipment Cost High Medium Medium Medium- Facility Cost High Low Medium Low- Cost of Goods High Medium Medium Medium- Supply Chain Solid ok Solid ok
SlowerHighLess MoreSmallLarger
FasterEasy
FasterLow
HighSmaller
SlowerPainful
Traditional Stainless Steel Technology Disposables Technology
Complex SimplerComplex Simpler
Low High
Expanded from an original concept in a table by Johannes Roebers, Senior Vice President, Biologic Strategy, Planning and Operation in Elan Pharma International Limited, presented initially to a PDA meeting in Dublin, Ireland in a paper entitled “Future Trends in Biopharmaceutical Manufacturing” and dated 25th June 2008
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Building Stacking Concepts - Horizontal
HVAC
Utilities Media Preparation & Cell Culture & Support Purif ication & Buffer Preparation & WarehouseMedia Hold Harvest Bulk Fill Buffer Hold
Horizontal Production Concept 1
HVAC
Media Preparation & Cell Culture & Support Purif ication & Buffer Preparation &Media Hold Harvest Bulk Fill Buffer HoldUtilities Support Utilities Warehouse
Horizontal Production Concept 2Both allow ease of material & personnel access to all production rooms without the use of stairs or elevatorsAvoids the transfer of tubing between floorsSuitable for Single Use (Disposables) and small scale stainless steel facilities
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Production all at one level
Thanks to Elan Pharmaceuticals for kind permission to use this image created by PM Group
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Important Concepts for single use (disposables) facilities
5S – Sort, Set In Order, Shine, Standardize, SustainBe organised, everything has it’s place
7 (now 8) WastesOverproduction, Waiting, Transportation, Inventory, Motion (non value added), Over Processing, Rework, (Talent)
Takt TimeThe “heartbeat” of the facility, used to standardise production time of workcells for line balancing
Mistake Proofing (Poke Yoke)Ensuring that the wrong connection is not made, or wrong bag assembly is not used
Line Side Warehousing“Pull” system to Kanban supermarkets in place of pushing to inventory
Lean Manufacturing
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Facilities of the PAST
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Facilities of the PRESENT
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Facilities of the FUTURE
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Futuristic Facilities of Today
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The Single-Use Facility of Tomorrow
• Bigger spaces
• Production oftenat a single level
• Lower gradecleanrooms
• Greateremphasis onLeanManufacturingprinciples
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CONCLUSIONThink beyond today because tomorrow will look very different !
Credits:Peter Hanson (PM)Jordaan Kemp (PM)Peter Hanson (PM)Ian Dacey (PM)Mark von Stwolinski (CRB)Kim Nelson (CRB)Alice Redmond (PM)Johannes Roebers (Elan)Per Karlberg & John Davis (GE Healthcare)
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Contact Details
Andy RaynerGroup Director of TechnologyPM GroupKillakee House,Belgard Square,Tallaght,Dublin 24,IrelandTel: +353-1-4040700E-Mail: [email protected]
Any Questions?