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ARTICLE · 24 MARCH 2026

From The Laboratory To GMP – Technology Transfer As The Second Inventive Step

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Everything looks promising in the laboratory. The formulation meets the assumptions, the parameters are within acceptable limits, and the test reports are consistent. However, the final verdict will not be made in the laboratory. The real test of technology is production: working at full scale under pressure from time, costs, and regulatory requirements.

PolandTechnology
Oliwia Czarnocka
Oliwia Czarnocka

Everything looks promising in the laboratory. The formulation meets the assumptions, the parameters are within acceptable limits, and the test reports are consistent. However, the final verdict will not be made in the laboratory. The real test of technology is production: working at full scale under pressure from time, costs, and regulatory requirements.

The differences between a 'working solution' and a 'repetitive process' become apparent when the product is transferred from R&D to the production plant. Scaling up changes the physics of the system: the mixing energies, temperature gradients, flow, and humidity dynamics are all different. Parameters that were stable at laboratory scale begin to behave unpredictably at industrial scale. Projects intended to reduce time-to-market can become stuck in the validation or technological correction phase for months.

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