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Manufacturing Scale-Up Challenges

Updated: Feb 19, 2021

The development of new products requires the expertise of talented researchers and engineers. However, these same professionals are typically not prepared to solve the many other critical problems necessary for successful commercialisation. Without the requisite expertise in scale-up and securing commercial traction, many early stage companies find that competitors beat them to the market or resources run out before success can be secured.

The successful transition of technology from the lab bench or pilot unit to the macro-level within a commercial production environment is certainly not an insignificant undertaking. Start-ups must utilise production facilities that satisfy the necessary requirements of timeliness, cost-effectiveness, regulatory compliance, political, economic and cultural constraints, and geographical proximity. If the proper manufacturing facilities and/or raw material providers cannot be located in an efficient manner, irreplaceable time and money are wasted.

Manufacturing scale-up can be viewed as a procedure for applying the same process to different output volumes. Any processes involved in manufacturing the product must be scalable in terms of economic factors, safety, stability, and efficacy. The fundamental production challenges remain the same: early design of a repeatable process, tools to develop that repeatable process and processing platforms that are scalable.

Production scale-up is rarely straightforward, with time-consuming, expensive and unexpected challenges often entering the picture. It is impractical to think this will take place without modifications, and the accomplishments at the lab bench will transform directly into success in commercial production. Hence, planning for scale-up should begin during lab trials. The plan can then be modified as more complete information and knowledge are gradually gained.

The complex task of process optimisation lays the groundwork for effective scale-up. During this stage, the manufacturing company needs to understand as much as possible about the process. This includes the key variables affecting the production process, which are monitored to detect changes in production operations and product output quality.

There is substantial exploration of processing solutions from the multidisciplinary engineering traditions to successfully scale-up a pilot or production plant. Design of Experiments (DOE) is a method to determine the relationship between factors affecting a process and the result of that process. A DOE is used to find cause-and-effect relationships, and is needed to manage process inputs in order to optimise the output, as well as to determine where there might be roadblocks to the manufacturing process.

Best practice taught us to ensure that timelines allow for issues and problems to come up. There will always be issues in large-scale manufacturing, which are steadily tackled and solved so they will not have rippling effect across the entire project. Ultimately, process optimisation is only as good as the manufacturing personnel handling it, and continuity is crucial to meeting timelines and budgets.

The objective of any start-up is to commercialise its technology in the shortest amount of time and as cost-effectively as possible. Any lost time is irreplaceable as the start-up risks burning through existing funds. Non-linear plant scale-up effects can be managed internally with the proper equipment, system sizing and construction materials, but at what cost?

Finding feasible substitutes requires experienced scale-up design specialists – both process development and plant construction – with thorough knowledge, and available equipment. Design engineers must balance cost savings and equipment selection without compromising the end goal of proving viability of final process and the physical plant scale-up.

Materials that are easily available and work in bench scale can be expensive and hard to find in large quantities. Production level equipment may be required to prove production level ability, even though the size of pilot plant does not require the same equipment as the production sized plant in order to work. All of this while keeping costs under control and running against deadlines to prove the process technology works.

There are two solutions to these manufacturing scale-up challenges – and Ainira Industries can assist you with both, having gained such comprehensive expertise by helping a large range of organisations in multiple markets and sectors over the past decade.

Firstly, it is the use of several modelling methods, which determine the limitations of the pilot plant scale-up through simulations, reducing costs, and eliminating the need to build successive test systems. Ainira’s professional engineers model this iterative process through computer simulations based on company’s laboratory or pilot scale data. The specific tools used to do this include multidisciplinary engineering modelling like the FEA, computational fluid dynamics (CFD), and process simulation, using a broad range of high-end CAE packages.

Secondly, it is the project management outsourcing alternative. Top Fortune 100 companies and countless corporations got outsourcing as an integral parts of their business strategy.

In this model, a company hires a firm to provide project management services for the project being outsourced. The Project Manager (PM) does not conduct the actual physical manufacturing using their own facilities. Instead, the PM provides access to a specialised network of suppliers of goods and services, with whom it maintains established relationships.

The PM provides industry vendors, such as contract manufacturing organisations with technical competencies, scope of capabilities, track record, business culture, available equipment, manufacturing capacity, scalability, and reliability. This leads to compressed timelines, lower operating and capital costs, and increased technical capabilities, providing a significant opportunity to the company to focus on new technology development, and sales and marketing efforts.

A competent PM will provide extensive technical and manufacturing experience, and can also facilitate the provision of auxiliary services as needed, including product development, raw material sourcing, logistics coordination, and regulatory support. Overall, the model itself is based upon a cooperative, risk-sharing foundation between the company and the project manager.

Effective outsourcing to contract manufacturing organisations provides a significant opportunity to accelerate product development, maintain operating budgets, and use internal resources effectively.

Start-ups may find that, in many cases, a combination of the manufacturing process simulation and the project management model offers the most benefits when it comes to successfully commercialising technology with limited budget and personnel, desired quality output, and within the shortest amount of time.

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