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BTL possesses many years of experience working with an array of in-vitro diagnostic products for different fields of application. We provide long-term production services for a defence-oriented organisation, following successful development of a freeze drying cycle suitable for their bioterrorism detection diagnostic products. We are also currently taking an active role in “AngeLab”, an EU FP7 project developing a versatile real time PCR-based medical diagnostic kit. Another recent success has been the development and production of the freeze dried form of a medical hygiene product.
Benefits of Freeze Drying
Freeze drying is an excellent choice for processing a wide range of diagnostic products because by virtue of their sensor properties they are often also temperature, light or oxygen-sensitive; freeze drying mitigates these processing challenges. Lyophilisation is routinely performed using low temperatures throughout the process, thereby avoiding any loss of activity through thermal damage to the product. Light sensitivity is addressed by back-filling the product vials with an inert, dry gas after freeze drying and then sealing the vials inside the dryer chamber. This is a routine operation with no special equipment required. Furthermore, light-sensitivity can be addressed through the use of amber vials, combined with opaque freeze dryer doors and a low-light environment for vial filling and post-processing.
After freeze drying, these products become much less temperature sensitive, and shelf life is dramatically increased. Freeze dried materials also boast rapid reconstitution rates which greatly accelerate the preparation of diagnostic products for use in the field, and superior activity can be maintained compared to the liquid form after long term storage. Lyophilised diagnostic kits can therefore be stored ready for use, without needing to thaw large volumes of liquid from frozen storage.
New diagnostic product packaging forms have been developed such as lab-on-a-chip and microfluidic cells, which offer several benefits for end customers including ease of use and a reduction in sample volume requirements. These chip-based products can be processed in a standard freeze dryer, and the smaller volumes of liquid involved can result in a significant reduction in cycle duration. Multiple solutions can be processed on a single chip, or different reagents added in stages allowing complex systems to be built up. BTL is capable of handling a variety of forms of packaging and kits that are proprietary to the client, thus promoting and supporting the client in the development of their innovative products.
BTL offers a full range of freeze drying services from formulation development, selecting a preferred formulation, freeze drying cycle development, post-cycle characterisation and cycle validation. We also have production facilities where we prepare, freeze dry and package diagnostic products in-house, and are capable of handling oxygen, light and temperature-sensitive compounds. Our experience in handling diagnostic products combined with our expertise in the freeze drying field means we are an excellent partner for developing a novel diagnostic product, changing the packaging form of an existing product from vials to chip-based or manufacturing of your product following agreed procedures.
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