retrofitting a new process to an existing facility
TRANSCRIPT
© Bioproduction Group. All Rights Reserved. 1
GOAL
Highly accurate process-based and economic modeling of a number • of new technologies as they would perform in the plant
New technologies assembled into a library of pre-configured ‘plug-and-• play’ unit operations that included detailed operational data
Showed the impact of changes to a single unit operation, the plant, • and the entire production network
Analysis guided a large biopharmaceutical manufacturer in their • selection of technologies for future plant build.
CASE STUDYBIOPHARMACEUTICAL
PLANT OF THE FUTURE
TO EvALUATE THE IMPACT OF NEw TECHNOLOGIES
IN ExISTING PLANTS AND NEw PLANT DESIGNS.
HIGH LEvEL SUMMARY
Whether you’re building a new plant or retrofitting an existing one, there are a myriad of technology options available to manufacturers. The recent explosion in disposables, as well as perfusion fermentation, continuous chromatography, inline dilution, and inline testing provide important cost reductions and labor savings as well as improving throughput.
However, biopharmaceutical manufacturers have traditionally avoided implementing such new technologies as the ‘cost of getting it wrong’ is very high. Small inaccuracies in throughput calculations (5-20%) can significantly impact the value of a new technology, as seen below.
More importantly, this graph suggests that accurately estimating process and throughput calculations is considerably more important than any other single metric. Bio-G’s brief was to evaluate the economic impact of new technologies currently being explored, to enable a large biopharmaceutical manufacturer to target areas where future technology development efforts should be directed.
THE BRIEF
THE COST OF GETTING IT wRONG:A Comparison Of The Economic Effect Of Calculation Errors
NPV ($MM) 20% Deviation10% Deviation5% Deviation
40
20
0
-20
-10
10
30
-30
Raw Materials Costs Construction Costs Quantity Produced
NPV $35MM)
© Bioproduction Group. All Rights Reserved. 2
MORE INFORMATION
BIOPRODUCTION GROUP [email protected] WWW.BIO-G.COM
SCIENCE BASE
Different operations:Equipment Data
Operating CharacteristicsEnergy/UtilityRequirements
PROCESSOPTIMIZATION
Process DescriptionRaw Materials Consumption
Operating TimesUnit Operations
Labor Usage
ANALYSIS
DESIGN
PROCESSANALYSIS ANDPERFORMANCE
Process SchemeResources Consumed
Plant ThroughputCycle Times
FACILITYANALYSIS AND
DESIGN
Capital & Operating CostsDirect & Indirect
HeadcountsEquipment
NEWTECHNOLOGYINNOVATION
FACILITYECONOMICS
Performance Data on areas of improvement
Key risks and performance requirements
Bottle-neck Analysis
HOw wE DID IT
Lee Schruben, Principal
“The critical insight is to realize that you can’t see unit operations in isolation.”
Bioproduction Group’s approach was to build a ‘Plant of the Future’ toolset that would allow rapid evaluation of technology alternatives. “The critical insight is to realize that you can’t see unit operations in isolation”, comments Principal Lee Schruben. “You need to integrate a new technology with existing technologies, and that means a robust understanding of current processes as well.”
Implementing this approach required Bio-G to use existing operational data at the manufacturer to produce datasets for cleaning, media and buffer preparation and other key activities that are common in any biopharmaceutical plant. This data was then combined with the new technology to understand how it would impact the overall plant performance.
Such an approach proved important in establishing an accurate estimate of throughput, and therefore an accurate estimate of cost. Variability in unit operation times was often just as important as the average time, resulting in highly congested facilities with mis-matched unit operations.
RESULTS Bio-G’s ‘Plant of the Future’ toolset created a highly accurate estimate of process fit and economic evaluation of a series of new technologies and possible process platforms. The toolset was used by Engineering, Process Development, Supply Chain and Manufacturing staff to understand the details of new technologies, and how they would fit in the manufacturing network. The approach allowed the manufacturer to show clear benefits to implementing key new technologies, minimizing technology risk and providing a road map for future plant and retrofit scenarios.