Formulation Development and Optimization

We work with you to develop a suitable formulation for your drug substance or drug product, through understanding its unique personality, to ensure stability of your molecule during preclinical, clinical, or commercial use.

We support the development lifecycle journey with:

Pre-formulation studies and formulation development
Characterization of your product through biophysical and biochemical assays
Process development and optimization
In-use studies
Primary packaging development for clinical or commercial use

We use regulatory-approved components, high-throughput technologies, and a broad range of stability-indicating biochemical and biophysical assays to evaluate your molecule from multiple angles.

Understanding Your Product’s Unique Personality

Evaluating the biophysical properties of the molecules we develop and manufacture is at the core of our belief that every protein is unique. Understanding the personality of every product is essential to the success of the medicines we support. 

This assessment is integrated during the initial product characterization as part of the development lifecycle. We do this by gathering product knowledge to ensure developability, successful manufacture and patient safety.

Our Approach

For most molecules, we tailor our processes to provide a formulation within four months from the receipt of the earliest purified protein originating from cell line development. This approach comprises four stages and begins with a bioinformatics approach dedicated to evaluating the impact of the molecule’s primary structure into its secondary, tertiary and quaternary structure, surfaces, patches and theoretical values to forecast the molecule’s potential behaviour.

Stage 1: Pre-formulation and “personality assessment”
Stage 2: pH, buffer type and excipient screening 
Stage 3: Predictive solubility 
Stage 4: Accelerated and real-time stability testing and a mock in-use clinical study

We also offer custom formulation development services.

We incorporate formulation development from the very beginning during construct selection as part of the initial product characterization. We continue assessments during the pre-clinical stage prior to IND submission, clinical trials before NDA submission, and again later during large-scale manufacture and fill-finish process – especially where changes are significant.

Additional services include: