Large sterile disposable systems and accessories are another trend. There are a number of economic advantages that can be realized with single-use systems. Disposable technology has found a role beyond buffer and media storage and into applications such as bioreactors, and membrane filtration and chromatography systems.
Disposable bag sizes of 1,500 L to 2,500 L are commercially available, and 10,000 L bags have been reported (Figure 5). Replacing large stainless steel tanks with disposable bags will not only lower facility capital equipment cost but also reduce manufacturing space requirements.
Another trend is the use of buffer concentrates and in-line dilution technology. Capital equipment represents about 4050% of the cost of a new biomanufacturing facility and a large percentage of that equipment is dedicated to the preparation and storage of buffers.
A typical biotech purification process requires, on average, 10 to 30 different buffers. Buffer volume ranges from 50100,000 L, depending on the scale. Most of the buffers used in the purification process are of low-salt concentration, which can be easily concentrated by 100-fold.
Use of buffer concentrate and in-line dilution technology will reduce the buffer hold and preparation tank size and result in space/equipment size reduction in both process and utility areas.
Buffer concentrates, coupled with disposable systems, can increase capital and operational savings. Care must be taken to ensure successful implementation of in-line dilution technology. It is important to understand pH, conductivity, and temperature shift during buffer dilution.
Process robustness related to the accuracy of buffer concentration must be carefully examined as well. Potential corrosion impact associated with the use of concentrated buffer can not be overlooked.
Powerful technology innovation, capitalization on the human genome project, and deep product pipelines will continue to fuel the growth of the biopharmaceutical industry. With advancements in manufacturing focused on R&D aimed at higher titer and yield, additional capacity demand does not necessary mean bigger fermentor and larger manufacturing facility.
Innovation in facility and equipment design will also lead to a much more compact and flexible facility, better able to meet increased capacity demand.