Case Studies: Solving Complex Biotech Challenges

At Dirty Data Consulting, we specialize in turning complex biotech challenges into actionable insights. While the specifics of our client engagements are confidential, here are examples of the kinds of solutions we've delivered across CMC, manufacturing, process development, and analytical data integration:

Case Study 1: Optimizing Glycosylation in Biosimilars

Challenge: A biotech company needed to fine-tune glycosylation patterns in their biosimilar product to meet regulatory requirements and improve therapeutic efficacy.

Approach: Our team applied advanced cell culture parameter adjustments, using data-driven modeling to assess and control critical variables. By integrating process data with glycan analysis, we built predictive models that enabled precise tuning of glycosylation.

Outcome: The company achieved the desired glycosylation profile, resulting in enhanced product consistency and regulatory compliance.

Case Study 2: DOE for Process Development

Challenge: A pharmaceutical development team needed to optimize a synthetic route for an organic compound, but struggled to balance yield and purity.

Approach: We developed a Design of Experiments (DOE) model, systematically exploring key parameters such as temperature, concentration, and reagent ratios. The model allowed us to predict the most favorable conditions for maximizing yield without compromising purity.

Outcome: The process optimization led to a 20% improvement in yield, significantly accelerating the timeline for scale-up and reducing costs.

Case Study 3: Troubleshooting Drug Substance Manufacturing Issues

Challenge: A client was experiencing unpredictable deviations in drug product quality during the final stages of production. The root cause was elusive despite multiple troubleshooting attempts.

Approach: We modeled the entire manufacturing process, combining upstream and downstream data with real-time analytical measurements. By using advanced multivariate analysis, we pinpointed a subtle interaction between excipient quality and temperature fluctuations during formulation.

Outcome: Our insights enabled the client to implement targeted process controls, which eliminated the deviations and improved batch consistency.