title: Biopharmaceutical formulations for pre-filled delivery devices.
abstract: BACKGROUND
  Pre-filled syringes are becoming an increasingly popular format for delivering biotherapeutics conveniently and cost effectively. The device design and stable liquid formulations required to enable this pre-filled syringe format are technically challenging. In choosing the materials and process conditions to fabricate the syringe unit, their compatibility with the biotherapeutic needs to be carefully assessed. The biothereaputic stability demanded for the production of syringe-compatible low-viscosity liquid solutions requires critical excipient choices to be made.
  
  
  METHODS
  The purpose of this review is to discuss key issues related to the stability aspects of biotherapeutics in pre-filled devices. This includes effects on both physical and chemical stability due to a number of stress conditions the product is subjected to, as well as interactions with the packaging system. Particular attention is paid to the control of stability by formulation.
  
  
  CONCLUSIONS
  We anticipate that there will be a significant move towards polymer primary packaging for most drugs in the longer term. The timescales for this will depend on a number of factors and hence will be hard to predict. Formulation will play a critical role in developing successful products in the pre-filled syringe format, particularly with the trend towards concentrated biotherapeutics. Development of novel, smart formulation technologies will, therefore, be increasingly important.
authors.affiliation: Arecor Ltd., 2 Cambridge Science Park, Cambridge, CB4 0FE, UK. jan.jezek@arecor.com
authors.forename: Jan
authors.initials: J
authors.lastname: Jezek
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Darton
authors.forename: Barry K
authors.initials: BK
authors.lastname: Derham
authors.forename: Nikki
authors.initials: N
authors.lastname: Royle
authors.forename: Iain
authors.initials: I
authors.lastname: Simpson
mesh_terms: D000818:Animals; D001688:Biological Products; D001702:Biopharmaceutics / Q000379:methods*; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004349:Drug Packaging; D004355:Drug Stability; D005079:Excipients; D006801:Humans; D013594:Syringes
chemical_list: D001688:Biological Products; D005079:Excipients