Biologics Formulation Development

Our unique approach enables customers to utilize a single organization for all their formulation and manufacturing requirements, which streamlines and de-risks the process and allows any experience and learnings to be shared across teams. This first-hand knowledge of the product can then be applied to rapidly solve any complex problems which may arise downstream.

Our state-of-the-art laboratories are equipped with the latest analytical equipment and methods to evaluate the integrity of your drug under an array of conditions to inform optimal formulation constituents and forms.

Our capabilities include:

• UHPLC systems
• Biophysical stability assessment platforms and particle size assessment equipment such as Prometheus, UNcle and ZetaSizer Ultra
• Mass spectrometry instruments (TOF MS, QTOF MS)
• Microfluidic platform (LabChip)

Analytical methods are essential to biologic formulation development, informing critical decisions and de-risking subsequent development phases. Through stress testing, forced degradation studies, and excipient compatibility assays, we identify optimal formulation conditions to maintain stability, extend shelf life, and that are appropriate for the desired route of administration. Particle size analysis and charge variant profiling further confirm that the product remains within defined quality attributes.

We also produce toxicology-ready batches under controlled conditions to support pre-clinical studies, ensuring consistent product characterization and safety.