title: Emerging freeze-drying process development and scale-up issues.
abstract: Although several guidelines do exist for freeze-drying process development and scale-up, there are still a number of issues that require additional attention. The objective of this review article is to discuss some emerging process development and scale-up issue with emphasis on effect of load condition and freeze-drying in novel container systems such as syringes, Lyoguard trays, ampoules, and 96-well plates. Understanding the heat and mass transfer under different load conditions and for freeze-drying in these novel container systems will help in developing a robust freeze-drying process which is also easier to scale-up. Further research and development needs in these emerging areas have also been addressed.
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, 69 North Eagleville Road, Storrs, Connecticut 06269, USA. patelsaj@medimmune.com
authors.forename: Sajal Manubhai
authors.initials: SM
authors.lastname: Patel
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Pikal
mesh_terms: D004349:Drug Packaging / Q000379:methods*; D005612:Freeze Drying / Q000379:methods*; D006358:Hot Temperature; D013242:Sterilization / Q000379:methods*; D013594:Syringes