Solid State Strategies lighted by: Quality by Design, Digital Design, Digital Twins, and Computational Fluid Dynamics, in 4.0 Industry.
Solid Consult Pharma
Caracteriza??o físico-químicas do estado sólido de formula??es farmacêuticas. Phisico_chemical characterization of OSF.
Today is the last text of the series and I hope you have enjoyed it!
Make-and-test approach still predominantly in the base of process and product development In pharmaceutical industry. What is critical from many points of view, however in a new scenario, in a VUCA word, (VUCA= volatility uncertainty complexity e ambiguity) the modus operandi has to change. And for some of us is the culturethatt should change first. With the upcoming of personalized medicines, this approach urges to be updatede, and a more strategic one knowledge-driven should appear to support the 4.0 industry.
??????????? An good example to overcome the make and test approach, is the project ADDoPT: Which objective was to “create virtual medicine manufacturing systems to make sure they are effective and efficient before creating them in the real world.” It is a “12 collaboration partners included four multinational pharmaceutical companies (AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline [GSK], and Pfizer), three technology-based small- to medium-size enterprises (SMEs) (Process Systems Enterprise [PSE], Perceptive Engineering, and Britest), and five specialist academic and research organizations (Universities of Leeds, Cambridge, and Strathclyde; Cambridge Crystallographic Data Centre; and the Science and Technology Facilities Council’s Hartree Centre).”
??????????? In the lats articles was discussed crystallization process. In the context of QBD I have cited for example the use of digital twins for the crystallization process as well the computational fluid dynamics (CFD) to improve the solid critical quality attributes. Add to these ones I’ve cited previusly the use of lattice energy to predict solubility, Gibbs energy to better understand the stability… all these tools have been well implemented in the context of by design. Understanding the overall manufacturing chain as an interconnected system calls for fundamentally different ways of thinking and working, which can include Improving compliance.
For incorporation the innovation of Digital Design in the pharmaceutical industry, in my point of view strong change management must be done, I used a paragraph from ISPE article entitled A Systems-Based Approach to Digital Design & Operation which capture this scenario:
“To succeed with a digital approach, the organization must implement a substantial cultural change that supports the move from old habits (using modeling to explain experimental results) to new (using models to ensure practical outcomes and identify experiments to verify outcomes). To succeed, the organization’s approach to recruitment and training must change, so it can develop scientists and engineers capable as experimentalists and model-errs, rather than perpetuating two separate communities.”
And this I can see as aintricated system that involves Academia, Industry, instrumentation seller,s and Government. For example with my partners who sell instrumentations, I see a lot of novelty in the market, improving the problem-solving as well as applications in the QBD approach. But to contact these new technologies, the doors need to be open, and listen without skepticism. And to open up what are the vulnerability in the industry product and process is a way to get help, from academia, seller and goverment. I understand some skepticism, but in my opinion, we can always say just a little and no (in case you don’t want help).
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Today I finish this newsletter on crystallization for pharmaceutical industry, and I hope I have brought for all you a holistic point of view of crystallization in the development of oral solid formulations, bringing the idea of QBD. With the Union of the Tree newsletter promoted by Solid Consult Pharma My hope is to bring an holist point of view. I put myself as a chess piece, and trying to put my background knowledge in service for our society in a strategic way, I hope most of the time I can be a queen.
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If you are interested in the others newsletters:
Polymorphism:
Particle size:
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