Use of Blast Freezers in Vaccine Manufacture A Case Study on Freezing Characteristics of Drug Substances in Disposable Containers

摘要

Vaccines are powerful and cost-effective prophylactic tools for protecting public health. The Global Alliance for Vaccinesand Immunizations (GAVI) estimates that ~5.4 million lives are saved each year by the administration of vaccines for hepatitis B, measles, haemophilus influenza type B (hib), pertussis (whooping cough), yellow fever, and polio (l). According to the WorldHealth Organization, seasonal influenza alone claims 250,000-500,000 lives every year globally, many of which could be prevented by more widespread vaccination with the seasonal influenza vaccine (2). Currently, vaccines are available for 26 indications, and those for at least 12 more indications are in clinical trials, with anticipated approval and launch in the next five years (3). Overall, the worldwide vaccine market registered revenues of US$10.6 billion in 2005 and $21 billion in 2008, and they are projected to increase to $35 billion by 2015 (4,5). Thus vaccines represent a clinically important sector as well as one of the fastest commercial growth sectors within the biopharmaceuticals market.