Process Understanding: For Scale–Up and Manufacture of Active Ingredients

Process understanding is the underpinning knowledge that allows the manufacture of chemical entities to be carried out routinely, robustly and to the required standard of quality. This area has gained in importance over the last few years, particularly due to the recent impetus from the USA′s Food and Drug Administration. Process understanding includes many interdisciplinary fields, such as formulation methods, pilot plant implementation, questions concerning scale–up, process design, plant design and more.
Discussing what this means to different disciplines and sectors throughout a product′s life cycle, this handbook and ready reference reveals the factors important to all the different sectors involved in the development and manufacture of chemicals.
The resulting interdisciplinary and general approach avoids case studies that are considered too specific, providing readers instead with the fundamental understanding necessary for a smoother technical transfer between the disciplines, leading to more efficient process development and manufacturing.
As a result, the book shows how process understanding can also deliver a real competitive advantage within the pharmaceuticals and fine chemicals industry, and serves as an aid to meeting the stringent regulations required by the relevant authorities.

Spis treści:
Initial manufacture for trial quantities
Data requirements and understanding for process development
Scale–up of chemical reactions
Analytical development
Pilot plant manufactures / initial manufacture at scale
Contract manufacturing
Equipment selection or manufacturing technology selection
Secondary/formulation development
Quality by Design
Established Manufacture – process control
Whole process design
Plant design and construction


Nota biograficzna:
Ian Houson is an Innovation Manager at Britest Ltd based in the UK. Having gained a first clas s hours degree in Chemistry and Oceanography from the University of Southampton, he completed a doctorate at the University of Oxford with Prof. John Brown FRS in organic chemistry. Ian then joined Zeneca, which became Avecia and finally NPIL where he was Chemical Process R&D Manager for the site. Joining Britest in 2007, Ian is now involved in training of Britest members, co–facilitating process development improvement studies and developing novel approaches and methodologies for process development

Okładka tylna:
Process understanding is the underpinning knowledge that allows the manufacture of chemical entities to be carried out routinely, robustly and to the required standard of quality. This area has gained in importance over the last few years, particularly due to the recent impetus from the USA′s Food and Drug Administration. Process understanding includes many interdisciplinary fields, such as formulation methods, pilot plant implementation, questions concerning scale–up, process design, plant design and more.
Discussing what this means to different disciplines and sectors throughout a product′s life cycle, this handbook and ready reference reveals the factors important to all the different sectors involved in the development and manufacture of chemicals.
The resulting interdisciplinary and general approach avoids case studies that are considered too specific, providing readers instead with the fundamental understanding necessary for a smoother technical transfer between the disciplines, leading to more efficient process development and manufacturing.
As a result, the book shows how process understanding can also deliver a real competitive advantage within the pharmaceuticals and fine chemicals industry, and serves as an aid to meeting the stringent regulations required by the relevant authorities.