Flexible biomanufacturing platform: not just a "beautiful sounding" technological vase
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- Issue Time
- Nov 20,2025
Summary
In the wave of biomanufacturing, pilot platforms are highly anticipated - they are the "bridge" connecting laboratory research and development with industrial production, and a key link in promoting the landing of innovative achievements.
The production line design of many pilot platforms is too "specialized", with severe singularity and a lack of flexibility and scalability.
Once market demand changes, these heavily invested production lines are likely to become idle decorations.
Why is it difficult for pilot platforms to achieve flexible production?
Let's first look at a key question: What is' flexibility '?
In the context of manufacturing, "flexibility" means that the system can quickly adapt to the needs of different products, processes, and scales, achieving "one machine for multiple uses and one click switching".
It is not a static device stack, but a dynamic response and flexible deployment intelligent system.
But on most current biomanufacturing pilot platforms, this "flexibility" has become a luxury.
1. Upstream universal, downstream "thousand people, one thousand noodles".
The upstream fermentation process is relatively standardized, and the fermentation tank, culture medium, control parameters, etc. have certain universality, with a high equipment reuse rate. But when it comes to downstream processes - extraction, purification, refining - the situation is completely different.
The downstream processes of each biomanufactured product may vary greatly: antibiotics vs. amino acids vs. enzyme preparations vs. protein drugs... Some require ion exchange chromatography, while others rely on crystal separation; Some are sensitive to pH, while others require low-temperature operation; Some require high purity, while others pursue high yield.
This means that downstream equipment must be customized according to specific processes, with extremely low universality. You cannot use a refined system to simultaneously produce insulin and citric acid.
2. The scale difference exacerbates the "rigidity" of the pilot stage, which is already not fixed in scale.
Some projects only require 100 level upgrade verification, while others require ton level amplification. The design of equipment is often based on a specific scale, and once a product or batch is changed, the entire process needs to be readjusted or even replaced.
This has led to an awkward situation:
Equipment is designed to serve specific processes and scales, rather than being born for 'flexible response'. Even if you try to improve flexibility through modular design, as long as the core process path is not consistent, the so-called "flexibility" is just talk on paper.
Flexibility: Is it a technological vase or a future direction?
Someone said, "Flexibility sounds great, but it's often just a technical vase that looks good but isn't easy to use, wasting resources
This sounds harsh, but it reveals the pain points of the industry.
Indeed, many so-called 'flexible platforms' simply assemble several devices together and label them as' switchable', but in reality, they still remain in the mindset of 'single variety assembly line'. Without a unified data interface, intelligent scheduling system, and standardized interface protocol, the so-called "flexibility" is just a false proposition.
But what we need to ask is: Is there not a possibility for the pilot platform to truly become "soft"?
What does a true flexible biomanufacturing platform look like?
If we look to the future, a truly flexible biomanufacturing platform should possess the following characteristics:
Modular architecture+standardized interfaces
Like Lego bricks, the fermentation, centrifugation, filtration, chromatography, drying and other unit operations are disassembled into independent modules, each module has standard input and output interfaces (such as pipelines, valves, sensors), and supports plug and play.
For example, today we are making enzyme preparations using the A+B+C module; Tomorrow we will produce vaccine intermediates and replace them with A+D+E modules, without the need for large-scale modifications.
The digital twin+intelligent scheduling system establishes a full process digital twin model, monitors the status of each module in real time, and automatically matches the optimal process path. When a new product is launched, the system can automatically generate a running plan and guide the operator to complete the switch.
Accumulate process data for different products through cross product process databases and rapid validation mechanisms, forming a knowledge graph. When a new project is launched, the system can recommend similar process routes and estimate key parameters to shorten the development cycle.
Similar to AI assisted diagnosis, but applied to biomanufacturing.
The ability to conduct small-scale, high-frequency, and low-cost trial production breaks the traditional model of "one-time investment, long-term use" and creates a shared pilot service of "on-demand activation and billing per use". Enterprises can rent platform resources based on projects to avoid heavy asset burdens.
Flexibility is not a gimmick, but a necessity for survival
In today's increasingly volatile global market and accelerating technological iteration, flexibility has become one of the core elements of enterprise competitiveness.
For startups and research institutions, if pilot platforms cannot provide sufficient flexible support, it means higher trial and error costs and slower conversion speeds;
For large enterprises, rigid production lines are also difficult to cope with multi category and short cycle market demand.
Therefore, flexibility should not be a 'icing on the cake', but rather a 'timely aid'.
Returning to the original question: Why can't the pilot platform achieve flexible production?
The answer may be: we built it too early as a 'factory' rather than designing it as an 'experimental field'.
The future biomanufacturing pilot platform should not be an amplifier for a single product, but an incubator for diverse innovation.
What it needs is openness, adaptability, and intelligence, not closure, solidification, and high cost.
Only by embracing flexibility can the pilot platform transform from a mere decoration into an engine driving industrial transformation.
