Case Study – Infimed

PEG Microsphere Delivery Platform for HGH

Situation

An emerging pharmaceutical company was developing a sustained drug release formulation for human growth hormone (rhGH) based on a 3-arm PEG 4.4kls macromer based microsphere technology. Phase 1 trial (and animal model results) yielded poor pharmacokinetic and pharmacodynamic responses. In addition, the formulation was difficult to consistently produce and six months of trial and error experimentation had failed to develop a reliable and scalable manufacturing process.

Approach

IMPACT performed a structured root causal analysis to identify and quantify problems in both manufacturing and bioavailability/biocompatibility.  IMPACT used Design of Experiments (DOE) methods, or conducting and analyzing controlled tests to evaluate the factors that control the value of a parameter, to prepare a new research strategy based on the root causal analysis findings. IMPACT’s experienced research, process development, and scale-up personnel then executed the experimental plan.

Results per the Client Testimonial:

“We brought in IMPACT to help us develop a new injectable sustained release technology for human growth hormone. Meeting critical product technology milestones had eluded the company for over three years and over $30 million of investment. IMPACT utilized its depth, experience, and structured approach to not only reformulate our entire research strategy but also implement the strategy and accomplish all of our technical goals in less than 8 months.”

– Chuck Abdalian, Former CEO Pelias Technologies, Inc. (formerly known as Infimed Therapeutics)