title: 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.
authors: School of Pharmacy, Shanghai Jiao Tong University, Shanghai, China.
authors: Jing
authors: J
authors: Su
authors: Jeffrey
authors: J
authors: Mazzeo
authors: Nanda
authors: N
authors: Subbarao
authors: Tuo
authors: T
authors: Jin
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage; D003692:Delayed-Action Preparations; D016503:Drug Delivery Systems; D015195:Drug Design; D004345:Drug Industry; D006801:Humans; D011506:Proteins / Q000008:administration & dosage* / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D059451:Biosimilar Pharmaceuticals; D003692:Delayed-Action Preparations; D011506:Proteins