Case Study – Epic Therapeutics

Microsphere Delivery Platform for API

Situation

A pharmaceutical company was developing a proprietary microsphere manufacturing process for inhalation-based API delivery. The existing, bench-scale manufacturing process was capable of meeting pre-clinical testing and client sample needs. The process, however, was neither consistent, nor easily amenable to significant scale up. The near-term need for larger quantities (10 to 100 fold) for toxicology and Phase 1 clinical studies required that the entire process be re-evaluated and optimized to both improve consistency and provide a longer-term scale up path.

Approach

IMPACT engineers leveraged their significant microsphere formation experience which included predictive modeling techniques, mixing parameter boundary testing, scale-up analysis, and larger-scale testing. IMPACT helped the client study the parameters affecting microsphere formation to better identify operational boundaries and define the trade-off between the controlling parameters. Studies included both predictive modeling, analysis and experimental testing.

Results

To date, the combination of modeling, analysis and bench scale testing have led to multiple possible scale up methods. IMPACT has helped the client design, build and test a continuous, aseptic system with a ~20 fold capacity increase. This system produces microspheres that are both consistent and very high quality. The client is on track to meet all applicable technical and business milestones for this product.

IMPACT is working with the client to apply this scale up experience to their other product lines. Jointly, we are identifying the common processing aspects amongst API candidates to develop general manufacturing process, while allowing flexibility to address those issues which are unique to a particular compound or biologic.

Testimonial

“IMPACT provides us with rapid, flexible, and cost effective access to a hands-on team of seasoned process development engineers with deep and broad skills that complement and augment our internal capabilities. Our close working relationship with IMPACT provides an effective alternative to recruiting full-time staff during periods of high process development demands. Their experience, perspective, and foresight significantly enhance our capabilities for developing robust commercial processes.”

– D. Davidson Easson Jr., Sc.D., VP Manufacturing & Process Development, Epic Therapeutics, Inc., a Wholly-Owned Subsidiary of Baxter Healthcare Corporation