Conference Report: Pharmaceutical Development of Biologics: fundamentals, Challenges and Recent Advances

Abstract

The 46th Arden Conference, held in West Point, NY, USA, March 2011, focused on development of protein therapeutics, comprising preformulation, formulation, manufacturing, advanced delivery systems, protein characterization/analysis, and regulatory landscape. The sessions of preformulation and formulation development consisted of nine lectures discussing protein stability implications and characterization during purification, freeze-drying and manufacturing. The session on advanced drug delivery encompassed two new sustained-release microsphere formulations (protein microencapsulation by annealing of premade porous PLGA microspheres and aqueous–aqueous emulsion for preformulating proteins to solvent-resistant particles), two transdermal insulins (patching after thermal ablation of skin and phase-transition hydrogel microneedle patch), and a responsible hydrogel system for intra-ear delivery. The sessions on analytical technologies and regulatory landscape both focused on challenges for biosimilars.

Acknowledgements

The authors thank the conference lecturers who kindly agreed to share their slides with readers of this report.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.