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Why Attend?

Designing and scaling up a microsphere formulation can be present significant challenges requiring extensive knowledge in pharmaceutical development and process and polymer chemistry. Scaling up a microsphere formulation can bring problems that don’t show up at lab scale, including residual solvent, shifts in particle size, lost encapsulation efficiency and changes in drug release. This presentation explains Oakwood’s continuous manufacturing approach to scale-up. It covers selection of the lead feasibility

formulation, solvent exposure studies, scaling of flow rate and batch size, and terminal sterilization. Several case studies show how polymer selection and processing parameters drive product performance.

You'll learn how to:

  • Identify the most common problems in scaling up microsphere formulations and explain what causes them
  • Assess how polymer selection and processing parameters affect encapsulation, release kinetics and stability for both peptide and small molecule drugs
  • Judge whether terminal sterilization is a practical option for a microsphere product, and what effect it has on product quality

Speakers

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Rachel Minrovic
Senior Engineer; Manager, Oakwood Labs

Rachel Minrovic is the manager of the R&D Formulations Group at Oakwood Labs, focusing on development and production of microsphere products and advancements in microsphere process technology. She is project lead of multiple projects involving the encapsulation and scale up of various active pharmaceutical ingredients into biodegradable polymeric microspheres, culminating in several patent filings on behalf of Oakwood Labs. These injectable microspheres, for both human and animal use, can extend the efficacy of APIs for as long as one week and up to one year in vivo.

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Stephen Ashbaugh
Engineer II, Oakwood Labs

Stephen Ashbaugh is a Formulations Engineer II at Oakwood Labs, specializing in the development of long-acting injectable microsphere products. He leads or supports multiple projects aimed at encapsulating

various active pharmaceutical ingredients within a biodegradable polymer matrix from the laboratory to pilot scale. Stephen holds a BSE in biomedical engineering from Case Western Reserve University where he minored in polymer science and engineering. He has been with Oakwood Labs since 2024.

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