Employing Single-use Technology to Control Frozen Bulk Drug Storage: The Cold Hard Facts
New biopharmaceutical drug products that alter and even save lives can be very profitable for their developers. They are, however, costly to develop and represent significant investment, particularly at the end of the manufacturing process. For this reason, safe cost-effective frozen storage and transport are critical, especially as drugs transition from R&D through clinical trial and to higher volume production. The objectives for choosing a new storage/transport method include minimizing both capital and operating expense, reducing facility space requirements, and cutting time and energy for clean-in-place and steamin-place processes. At the same time, valuable product must be protected from cross-batch or other sources of contamination.
The traditional approaches for primary packaging in frozen applications have been bottles and stainless steel cryo vessels. While each has its strengths, both have significant shortcomings. Bottles are bulky, non-scalable, and can slow freezing and thawing. A system of cryo vessels is costly to build and operate and adds layers of complexity in the return, cleaning, and reuse of vessels. For these reasons, manufacturers are adopting a system of single-use bags to eliminate bulk, scale as necessary, control freezing and thawing, and eliminate the need to manage container returns and reuse.
This paper addresses the challenges of bulk drug substance (BDS) storage, shipping, and other critical factors users must consider in deciding whether and how they will adopt the technology. It will touch on material challenges and on the filling, freezing, storing, transporting, and thawing process requirements that single-use packaging must meet. Finally, it will present specific options to consider in moving toward single-use drug substance storage.