Abstract

CHALLENGES TO OPTIMISATION AND SCALE-UP OF THE PROCESS OF LYOPHILISATION OF PHARMACEUTICALS

Sutapa Biswas Majee* and Gopa Roy Biswas

Abstract

With the advent of biopharmaceuticals into the market, lyophilisation or freeze-drying forms an essential step in their manufacturing technique. Stability and sterility are achieved more easily with the process than with other conventional techniques. Design, development, control, optimisation and scale-up of the process requires consideration of several aspects such as theoretical knowledge of the stages of freeze-drying cycle, determination of end-point of primary drying stage, evaluation and analysis of the process and the product, techniques for optimization in practice and their relevance to the variables in question. Application of the process in commercial scale throws up challenges in terms of design of dryer, batch size, duration of process. Description of factors responsible for problems related to scale-up should be investigated in details and should be appropriately controlled to reduce the production cost to a minimum without compromising with the process efficiency or product quality.

Keywords: lyophilisation, freeze-drying cycle, commercial scale.