Manufacturing Technology Innovation: Who is Responsible for Development and Commercialization

Many will and do claim ownership of technologies that produce quality products at the lowest cost. This is great and necessary for continuous progress. Over the last 90+ years pathways have been carved by many. All suggest that pieces parts must be put together properly for a process of economic value. 

I am presenting my perspective of what I have learnt, and believe in and who should be credited for the innovations. All views are personal. There is no financial interest/conflict with any educational/commercial or regulatory body. 

Universities:

Looking at chemistry and chemical engineering text books, our professors postulate, create, and develop fundamentals, theories and hypotheses that were/are confirmed in the university laboratories. New concepts, applications are continually developed and being used. They move from university benches to pilot plants of equipment vendors and commercial operations if applicable. At times concepts, theories and potential solutions proposed by educators might be conceptually feasible but still have to be proven or modified in the laboratory and economically justified by commercial users. Their economic value has to be proven. 

Commercial Operations:  

Chemists and chemical engineers apply fundamentals and concepts developed at the universities to enhance existing and create different/alternate unit processes and operations. Process of continuous improvement never stops. At least that is what we were and are taught and practice. 

Concepts developed in universities before they can be commercially used have to be proven using existing or new equipment for safety and economic feasibility. Developers (chemists and chemical engineers) apply their imagination and creativity to develop and modify existing processes by manipulating mutual chemical behavior also. 

Equipment vendors on an ongoing basis improve capabilities of their equipment. Chemists and chemical engineers who dream and envision applicability of the new and existing equipment develop or modify new and existing processes to improve product quality and lower costs. All of these have to be proven and economically justified before they become commercial. 

Regulators:  

Regulators create boundary conditions of quality and safe performance. Products have to meet established requirements. Roadmaps are laid out to facilitate good manufacturing (cGMP). It is economic for each manufacturer to use defined and proven principles of chemistry and chemical engineering to produce quality products from the get go. There are financial losses if the product has to be reworked or disposed of or sold as “second grade”. Regulators should let the commercial producers produce products and assure product quality and safety. They should abstain from suggesting how to manufacture as they have no proven experience. 

 

Schematic in Figure 1 is the way I believe how the innovation flow has happened and should continue. 

Some Misconceptions: 

Lately developed and proven concepts that have been practiced for over fifty years are being renamed as new concepts or technologies. Wonder WHY? Is it to suggest that old developed and proven practices will do better under the new names or the best practices still being used are no good under the old names? 

For illustration or discussion, in sixties chemist and chemical engineers were/are taught and trained that yield improvement of a chemical process is expected and should be an ongoing process. Conservation (yield improvement) was expected part of the everyone’s job. Processes and solvents used were modified or substituted to maximize safety and health and minimize environment impact. Use of chemicals was based on prevailing toxicity knowledge. In late nineties yield improvement and/or use of environmentally friendly chemicals started being glorified as “Green Chemistry”⁽¹⁾. 

New name suggests same old practices process yield/safety/environmental improvements and implies that the practices of sixties, seventies, eighties and nineties were subpar. Were they? They could not have been as best of the chemical manufacturing technologies were developed, commercialized and continuously improved before the name “Green Chemistry” was coined. These technologies gave leadership to most companies in their respective businesses. 

Similarly “flow chemistry” ⁽²⁾ is being touted/suggested as a new technology/methodology that will improve manufacturing and solve every conceivable issue. According to Wikipedia ⁽²⁾ the term has only been coined recently for application on a laboratory scale. On commercial scale liquids flow in a batch as well as a continuous process. Thus, I am not sure if “flow chemistry” has any value when it applies to laboratory only. Is flow of fluids in the laboratory any different from flow of liquids in a commercial operation? Economics of lab is very different from commercial operations. Reaction kinetics can be exploited on commercial scale and that can change the economics. Laboratory can be used to test concepts. 

Lately some batch processes ⁽³⁾ are being labeled as continuous ⁽⁴⁾. Is it for people to look good or create confusion among the less experienced? Even the regulator with no proven experience in such processes chime in, adding to the confusion. We cannot dismiss that in large scale operations, batch production is for many products with limited yearly demand whereas continuous production ⁽⁴⁾is for a SINGLE product that is to be produced year-round except for scheduled stoppage in the same equipment. We cannot alter 2+2=4 and if we do, then we have to re-write every book.

Lately regulators, equipment vendors and educators are suggesting practitioners at manufacturing organizations what types of processes they should use as if the practitioners don’t know what is good for their operations. Question needs to be asked have either of these entities have developed, designed, understand product economics and market dynamics of the products in question. We have to recognize that manufacturing companies have not been using mortar and pestle and taste to produce quality products. They have and are using fundamentals of science, engineering and economics every day.   

What it should be?

We should agree that each entity mentioned above does a great job of what they have chosen to do ⁽⁵⁾. We have extremely innovative, imaginative and creative people. We should let each without any encumbrance do the best to develop best manufacturing technologies so that the final product being offered to the consumer is most economic and of the highest quality. Interference results in wasted effort with no return on investment. 

Girish Malhotra, PE

EPCOT International

1.    Green Chemistry

2.    Flow Chemistry

3.    Batch Process   

4.    Continuous Process

5.   Malhotra, Girish: Who is responsible for Manufacturing Technology Innovation, Contract Pharma, September 11, 2018