The last twenty years has seen significant investments in biopharmaceutical manufacturing in Ireland and this is set to continue with the likes of BMS, Pfizer, Eli Lilly, Regeneron, Shire and Alexion all undertaking major biopharmaceutical capital projects in Ireland.
Adequate bioburden control is of paramount importance to the production of biopharmaceuticals and this is achieved through proper equipment preparation, a combination of cleaning, steaming-in-place (SIP) and hot water sanitisation and careful control of process additions.
Whilst the industry has seen a move away from the blanket use of SIP across all areas of the process this is still a common approach. The removal of SIP from process steps can provide significant capital and plant complexity reductions. However the sanitisation activities need to be carefully managed, as part of a holistic contamination control strategy, in order to ensure the integrity of the process is not compromised.
The increased use of single-use systems, perhaps limited by processing scale, can offer significant benefits.
This article is based on a presentation given at a recent Engineers Ireland seminar on ‘New Approaches and Technologies in Biopharmaceuticals’. Before examining bioburden control itself, however, one must define what constitutes biopharmaceutical products and hence the importance of bioburden control, in order to place it context.
A biopharmaceutical is typically defined as ‘any medicinal product manufactured in, extracted from, or semi-synthesised from biological sources’. They can be composed of proteins, sugars, nucleic acids, living cells or tissues.
Biopharmaceuticals can also be defined by reference to their method of manufacture (generally isolated from natural sources: microorganisms, humans, plants or animals). They include a wide range of products such as: