Purification Made Simple
Process Intensification Is Process Design, Not Process Development
Lisure Technology is launching a technical roadshow exploring the engineering fundamentals behind Process Integration, Connected Processing, and Continuous Manufacturing. Rather than focusing on individual pieces of equipment, the program examines how complete downstream manufacturing systems can be redesigned for greater efficiency, scalability, and operational simplicity.
7/29/20263 min read
Process Intensification Is Not Process Development—It Is Process Design
For more than a decade, Process Intensification (PI) and Continuous Manufacturing (CM) have been among the hottest topics in biopharmaceutical manufacturing. Pharmaceutical companies continue to invest heavily in continuous chromatography, connected processing, inline conditioning, PAT, automation, and digital manufacturing.
Yet despite this tremendous progress, one fundamental misconception continues to influence how these technologies are evaluated and implemented.
Process Intensification is frequently viewed as an extension of process development or process re-development.
We believe this assumption deserves to be questioned.
The Wrong Question
When discussing process intensification, many organizations immediately ask:
"Do we need to redevelop our purification process?"
This question naturally leads to concerns such as:
Will product quality change?
Will we need additional process characterization?
Will regulatory filings become more complicated?
Will development timelines increase?
Is the investment justified?
These concerns are understandable—but they originate from treating PI as another process development activity.
In many cases, that assumption is incorrect.
Process Development and Process Design Are Different Disciplines
Process Development answers scientific questions.
Which chromatography resin should be used?
What pH provides the highest yield?
What conductivity gives the best impurity clearance?
What loading density is acceptable?
What operating window produces the desired product quality?
The result of process development is a validated purification recipe.
Process Design addresses an entirely different set of engineering questions.
How should unit operations be connected?
Can two processing steps become one?
Can intermediate holding vessels be eliminated?
How should materials move continuously between operations?
How should process dynamics be managed?
What automation architecture is required?
How can manufacturing cost, footprint, and cycle time be reduced?
These questions do not change the purification science.
They change how the same science is executed.
This distinction is subtle but profound.
Process Intensification Is About Better Manufacturing
Consider a conventional downstream purification train.
A harvest enters depth filtration.
The filtered material is transferred into a holding vessel.
The material is pumped into Protein A chromatography.
Another holding vessel follows.
Buffer exchange is performed.
Another vessel.
Virus filtration.
Another vessel.
TFF concentration.
Another vessel.
Each unit operation performs its intended scientific function successfully.
Yet the manufacturing process contains significant waiting time, large buffer inventories, unnecessary equipment, repeated product transfers, additional cleaning operations, and increased facility footprint.
None of these inefficiencies originate from the purification chemistry.
They originate from the manufacturing design.
Process Intensification seeks to redesign this manufacturing architecture.
The Three Levels of Process Intensification
Although PI is often associated only with continuous manufacturing, it is better understood as three progressive levels of process design.
1. Process Integration
Can multiple operations be combined into one?
Examples include:
Filtration integrated with chromatography
Buffer exchange integrated with chromatography
Capture followed directly by virus filtration
Hybrid unit operations that eliminate intermediate processing
The objective is to reduce equipment count, shorten cycle time, and simplify operation.
2. Connected Processing
Can independent unit operations transfer material directly from one process to the next?
Instead of viewing holding tanks as mandatory components, connected processing asks whether they are actually necessary.
Achieving reliable direct material handover requires careful consideration of:
Process architecture
Residence time
Flow synchronization
Dynamic process behavior
Automation strategy
The challenge is no longer chemistry.
It becomes engineering.
3. Continuous Manufacturing
The highest level of process intensification asks an even more ambitious question.
Can an existing batch process operate with constant feed entering the process and constant product leaving the process?
Contrary to common belief, this does not necessarily require inventing an entirely new purification process.
It requires designing a manufacturing system capable of sustaining continuous operation while maintaining the original process intent.
Continuous manufacturing therefore represents the evolution of process design—not necessarily process development.
Why This Matters
This distinction has important implications for the pharmaceutical industry.
If PI is viewed primarily as process redevelopment, organizations naturally assign responsibility to process development teams.
If PI is recognized as process design, implementation becomes a multidisciplinary engineering effort involving:
Process Development
MSAT
Manufacturing
Automation
Plant Engineering
Digital Manufacturing
Validation
CMC
This broader perspective encourages earlier collaboration and allows manufacturing, automation, and engineering considerations to influence facility design from the beginning rather than after development is complete.
Technology Is Only Part of the Story
Today's industry offers an impressive collection of enabling technologies.
Continuous chromatography.
Inline conditioning.
Continuous TFF.
Advanced automation.
PAT.
Digital twins.
Smart instrumentation.
Each technology solves an important technical problem.
However, technology alone does not create an intensified manufacturing process.
Without a coherent process design philosophy, these technologies often remain isolated solutions rather than components of an integrated manufacturing system.
The true value of process intensification lies in designing how these technologies work together.
Looking Forward
As the industry continues moving toward flexible manufacturing, smaller facilities, lower capital investment, and faster technology transfer, process design will become increasingly important.
The future of biomanufacturing will not be determined solely by faster chromatography columns or more advanced filtration systems.
It will be determined by how effectively entire manufacturing processes are designed, integrated, connected, automated, and eventually operated continuously.
Perhaps it is time for the industry to rethink the basic assumption.
Process Intensification is not simply about developing a different process.
It is about designing a better one.
Lisure Technology is launching a technical roadshow exploring the engineering fundamentals behind Process Integration, Connected Processing, and Continuous Manufacturing. Rather than focusing on individual pieces of equipment, the program examines how complete downstream manufacturing systems can be redesigned for greater efficiency, scalability, and operational simplicity.
Because the future of bioprocessing is not individual continuous processing equipment.
It is advanced process design.