Buffers are the largest component of downstream processing by volume [2], and as such, storage can be a challenge for many manufacturers. The need to store 25,000 L of ready-made buffer, for example, creates a large amount of facility dead space. Even with appropriate temperature warehousing, once prepared, every buffer has a shelf life after which it becomes unviable. Preparing and storing buffer in-house risks wastage and loss of investment if the full amount of the buffer cannot be used in time.
Buffer preparation and storage for a standard monoclonal antibody can require up to 30% of a facility’s valuable floor space, which could be otherwise used to expand manufacturing capacity. A simple solution to reclaim some or all this footprint is to outsource buffer preparation entirely, eliminating the need for mixing tanks and their maintenance, with the added benefit that capital and operating costs are reduced as a result.
Utilizing an outsource partner’s cGMP warehousing and taking advantage of just-in-time delivery, so that only the right amount of buffer is delivered exactly when it is needed, significantly reduces on-site storage needs. Removing these constraints opens up the opportunity to repurpose facility usage and supports growth.
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