Protein Formulation Development

Stability Studies

Accelerated stability studies are a type of stability testing that is used to evaluate the stability of proteins in liquid and solid dosage forms under conditions that are more severe than those that the product will typically experience during storage and use. The goal of accelerated stability testing is to determine the shelf life of the product and to identify any potential degradation mechanisms.
There are several factors that can affect the stability of proteins in liquid and solid dosage forms, including temperature, humidity, light exposure, pH, and the presence of other chemicals or contaminants. During accelerated stability studies, these factors are controlled and the protein is exposed to conditions that are more severe than those that it would normally encounter, such as higher temperatures or higher humidity levels.

To conduct accelerated stability studies of proteins in liquid and solid dosage forms, a sample of the product is prepared and stored under accelerated conditions for a specified period of time. The protein is then analyzed at regular intervals to determine its stability, including its concentration, purity, and functional activity. Any changes in the protein's properties are monitored and used to determine the shelf life of the product and to identify any potential degradation mechanisms.

Accelerated stability studies are an important part of the development and quality control of proteins in liquid and solid dosage forms, and they are essential for ensuring the safety and effectiveness of these products. HTD has expertise in accelerated stability studies and can provide high-quality services to our clients to support the development of safe and effective products.

Protein Characterization

Offers a range of analyses and studies to support the characterization of proteins, including differential scanning fluorimetry, dynamic light scattering, and viscosity measurement.

​​​​​​​Our services include determining protein identity, purity, content, and bioactivity using high-throughput technologies. We work with a wide range of proteins in different formats, including purified proteins, protein-ligand complexes, and protein formulations. HTD is equipped to provide a highly detailed and accurate characterization of proteins for research and development purposes for our clients.

iFormulate™​​​​​​​

iFormulate™ is a unique formulation development platform developed by HTD Biosystems.

iFormulate™ accelerates the development of biotech drugs. The iFormulate concept is based on an efficient high throughput algorithm that utilizes rational design of experiments and formulation parameters, to develop a pharmaceutically acceptable drug product.