Analytical, Stability & Formulation

Analytical

We complement our manufacturing activities with a full spectrum of analytical development services. Assays are developed and qualified for use in release and stability testing, in-process testing and for characterization of products, impurities and reference standards.

The analytical development team works closely with the upstream and downstream development groups, providing support during this time. Our labs are fully equipped with state-of-the-art instrumentation. Techniques include:

Chromatographic (using Agilent HPLC's)
Electrophoretic (SDS-PAGE and IEF)
N-terminal sequencing (using Agilent and ABI instruments)
DNA sequencing
Binding studies (using plate readers and BIACore)
Capillary Electrophoresis
Mass Spectrometry (QStar ESI-LC/MS/MS, LCQ, Voyager MALDI-TOF, Mariner)
Carbohydrate Characterization (monosaccharide composition, oligosaccharide profiling)
Biophysical Characterization (CD, DSC, FTIR, Light Scattering)

Stability and Formulation

Our reputation for scientific excellence has developed as a result of our experience across a wide range of proteins. So we know that formulation development is crucial for a biologic product. We have developed formulations for proteins that take into account mode of delivery and which supports the required pharmacokinetics and product stability.
Our formulation services include:

Design of product composition for liquid and lyophilized formulations
Pre-formulation studies to select and optimize components for a liquid or lyophilized formulation
Assay development and accelerated stability studies to generate stability indicating profiles
Analysis of protein aggregation, primary, secondary and tertiary structure
Development of product lyophilization cycles

Diosynth Biotechnology pharmaceutical services group, supported by our analytical development and quality functions, undertakes accelerated and real time stability studies for products, intermediates, and reference standards on behalf of our customers. Each study is individually designed to meet specific customer needs and includes:

Stability test protocol development
Validation of stability indicating assays
Continuously monitored stability chambers, each alarmed with backup and redundant power supply
ICH recommended storage conditions for real-time, accelerated, and photostability testing

See also