Long-Acting Injectables (LAI): Microsphere Design, Development and Scale-up

Pharmaceutical, Drug Discovery & Development, Medical Device, Medical Device Design,
  • Wednesday, September 06, 2023

Register for this webinar on long-acting injectables and learn about the selection and optimization of long-acting microsphere formulations with releases ranging from weeks to one year, applying a diverse portfolio of bioresorbable polymers to a unique polymer-based injectable microsphere platform.

The presentation will showcase the selection and optimization of long-acting microsphere formulations with releases ranging from weeks to one year, applying Ashland’s Viatel™ polymer portfolio to Oakwood Laboratories’ Chroniject™ platform. Ashland and Oakwood Laboratories will present together, respectively discussing the chemistry of bioresorbable polymers applied to various parenteral formulations and a microsphere technology platform that offers reproducible, scalable and consistent critical quality attributes under cGMP for multiple therapeutic indications.

microspheres

Ashland will show how understanding the chemistry and versatility of Viatel™ polymers helps solve challenges in controlled drug release formulations and medical devices. Ashland will also introduce their NEW Viatel™ Ultrapure polymer grades and detail the advantages of ultra-low (≤ 0.5%) residual monomer specifications.

Oakwood Laboratories will present two small molecule active pharmaceutical ingredient (API) microsphere case studies, (1) from formulation development through scale-up and (2) highlighting common scale-up challenges and solutions. They showcase how varying process parameters and polymer chemistries based on lactide and glycolide make it possible to optimize drug load, release duration, particle size and encapsulation efficiency.

 

Speakers

Dr. Seán McMahon (PhD), Ashland

Seán McMahon, PhD, Global Business Manager – Injectables, Life Sciences, Ashland

Dr. Seán McMahon manages Ashland’s ViatelTM bioresorbable polymer platform, supporting customers with polymers and technical solutions in the development of long-acting injectables, medical devices, tissue engineering scaffolds and injectable dermal fillers.

He joined Ashland through the acquisition of Vornia Ltd. acquisition, where he was CEO. His background includes lactide/glycolide/caprolactone and customized chemistries, with extensive knowledge of bioresorbable polymer design, chemistry and processing technologies used in medical applications.

Sean’s work is published on polymer design for pharmaceutical and medical applications in many research/peer review journals. He holds a bachelor’s and master’s degree from the National University of Ireland, Galway (NUIG) and a PhD from the School of Medicine (Dermatology Unit) and Medical Sciences at the University College Dublin (UCD), Ireland.

Message Presenter
Rachel Galaska, Oakwood Laboratories

Rachel Galaska, Formulation Engineer, R&D, Oakwood Laboratories

Rachel Galaska focuses on development and production of microsphere products and advancements in microsphere process technology, and her work has culminated in several patent filings on behalf of Oakwood. She is team leader of multiple projects involving the encapsulation of various active pharmaceutical ingredients (API) into biodegradable polymeric microspheres. 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.

Rachel has a bachelor’s degree in chemical engineering from the University of Dayton, where she performed research in developing cell-based in vitro silver nanoparticle pharmacokinetic profiles in efforts to bridge the in vitro/in vivo gap.

 

OakwoodLogo

Message Presenter

Who Should Attend?

  • Research and Development
  • New Product Development
  • Formulations
  • Principal Scientists
  • Technical
  • Regulatory
  • Business Development
  • Marketing
  • Process Engineer
  • Project Management/Pilot Plant
  • Pharma Manufacturing

What You Will Learn

Attendees will learn how:

  • Viatel™ polymer chemistry and process parameter controls can help achieve tunable release profiles of long-acting drug formulations
  • Development and scale up challenges can be approached and overcome using Chroniject™ technology
  • Strategies in microsphere technology can be coupled with appropriate bioresorbable polymers to deliver various molecules with tunable release profiles

Xtalks Partner

Ashland

Ashland’s pharma business is well known for acetylenics, cellulosics, and film coatings, and their polymers have a rich and diverse history supporting active pharmaceutical ingredient delivery. Deploying resources to build on their existing high impact and high value technologies, they are widening their portfolio of cellulose-based polymers (HPMC, HPC, CMC, HEC, EC), growing their excipient portfolio for injectables/biologics, including the possibility for customization, and they’re focusing on film coatings that live up to customer needs.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account