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Nanolytics GmbH
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  5. High-Concentration Formulations Service

High-Concentration Formulations Service

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Nanolytics offers advanced solutions for the subcutaneous administration of biologics requiring high-concentration formulations, utilizing the AIDA (Advanced Interference Detection Array). This detector allows precise handling of high protein concentrations, critical for subcutaneous injections where volume is restricted, such as in self-administration devices or ocular injections. The AIDA detector supports concentrations up to 150 mg/mL and includes specialized algorithms for unique analyses of protein aggregates within concentrated solutions. Notably, the sedimentation velocity of antibodies at concentrations up to 147 g/L can be effectively analyzed with the AIDA, overcoming limitations of standard ultracentrifuges that fail to resolve steep concentration gradients in such environments. This allows for comprehensive profiling of monomeric, dimeric, and aggregated antibodies, bringing significant advancements to the field of biologics.
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Subcutaneous administration of biologics often results in lower cost and increased patient safety and convenience, especially in a self-administration setting via injection devices such as pens, auto-injectors, or on-body-injectors. To deliver the appropriate dose, these drugs often require a high-concentration formulation, since the injection volume is much lower compared to an intravenous infusion. The same holds for many ophthalmology drugs: Injections into the eye ball require high purity and high concentration, since the injection volume is very limited.

Nanolytics offers a specific detector (AIDA – Advanced Interference Detection Array) to tackle even extremely high protein concentrations up to approximately 150 mg/mL. Along with the improved availability of specific data algorithms, Nanolytics will provide you with unique services for quantifying aggregates in highly concentrated protein solutions.