The creation of any ready-to-use product from Research & Development (R&D) needs to consider the ‘five Ps’ of Good Manufacturing Process (GMP):
The creation of any ready-to-use product from Research & Development (R&D) needs to consider the ‘five Ps’ of Good Manufacturing Process (GMP):
1. a clear Product,
2. skilled People,
3. clear Processes,
4. correct Procedures,
5. clean, safe and appropriate Premises.
To put the Premises part of GMP into context, creating the right premises is a prerequisite for any successful commercialization of R&D, via GMP, to be realized, be it for bioscience or any other manufacturing. The Premises need to be efficient, safe and purpose built as the manufacturing Process for life science companies is complex, with strict Procedures, requirements (MHRA, EMA and FDA certification required) and environmental conditions required to ensure that the Product is safe for human use.
At the center of this are People; without People there is no Product. The skills required for manufacturing are different to those needed for R&D, therefore, it is integral that your Premise is located among relevant skilled workforce. Seventy percent of the UK’s manufacturing workforce live within a 2-hour drive of Stevenage1. This workforce, combined with the government, launched the Cell and Gene Therapy Catapult (CGT Catapult) in 2012. This has led to Stevenage becoming the third largest Cell & Gene Therapy cluster globally, and the largest outside the US2. Cell & Gene Therapy (CGT) is classified as an Advanced Therapy Medicinal Products (ATMP) and involves an extremely high regulatory hurdle given the application to human genes, tissues and cells.
So why is manufacturing (GMP) so critical to the commercialization process? The journey from product discovery to pre-clinical and clinical stage is often long and complex. Critically, even at the product discovery stage, there needs to be an understanding of how the product can be manufactured, in order to ensure viability.
This initial stage of product discovery is largely conducted in an R&D lab until a conceptualization point is realized, following which initial manufacturing of the product can take place. It is at this stage that a company would require GMP space. Therefore, manufacturing is critical to the commercialization of a Product.
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