Protein-based Therapeutics
Protein-based therapies are a rapidly growing class of pharmaceuticals, based on recombinantly produced proteins, encompassing enzymes, hormones, peptides and antibodies. In general, proteins are prone to aggregation. Protein aggregation in pharmaceuticals can have serious effects on safety, efficacy, and stability. Furthemore, this class of medicines are typically administered by injection and the presence of unwanted particles of any type is therefore of great concern. As well as aggregates formed of the protein drug itself, other unwanted particles may include droplets of lubricant from the injection syringes and plastic, rubber, metal, or glass particles from production equipment and storage containers.
Holographic particle analysis using DAISY-NTA offers a powerful tool for detecting, quantifying, and differentiating particles in protein-based therapeutics at all stages of development and manufacture
Advantages of DAISY-NTA:
- Differentiates between different particles types, for example protein aggregates and lubricant oil droplets. This enables you to identify the source of the unwanted particles and better evaluate the resulting hazard.
- Low sample volume requirements. DAISY-NTA provides consistent and reliable results from as little as 10 µl of sample.
- Optical size determination is independent from sample viscosity.
- Using optical size determination, changes in size of protein aggregates can be studied with a time-resolution of much less than a second. This can provide additional information on aggregation kinetics
