MedPharm was asked to provide multiple 25 kg batches of a complex cream for a Phase 2 atopic dermatitis clinical trial on behalf of a global pharmaceutical company. A failure to supply or delay would have carried significant financial consequences for the project. The client specifically valued MedPharm’s detailed understanding of the product’s multi-stage manufacturing process.

Our experts leveraged their deep knowledge of formulation and years of experience scaling complex semi-solid products to identify the Critical Process Parameters (CPPs): homogenization speed and time, and cooling rates at various stages. A factorial design of 12 runs was created using 1 kg lab reactors to model the commercial scale.

The key Critical Quality Attribute (CQA) was the rheology profile of the final product. This work revealed the product’s rheology was particularly sensitive to homogenization time and speed, enabling our team to set precise processing parameters. A successful initial run at scale confirmed the robustness of the selected approach.

MedPharm subsequently produced over 15 clinical batches with consistent, reproducible quality using this optimized process. Without this early process evaluation, the client likely would have faced significant material loss and delays. Our targeted approach ensured efficient use of a high-value API and helped keep the clinical trial on track.