Hepatitis A Case Study

Introduction

Fill Finish is the most critical process in a biopharmaceutical facility due to its highly technique driven processes and the potential safety impact to the patient. The target of this project is to analyse the facility of my hepatitis A vaccine fill finish operations including the closure system and choose an appropriate equipment that best fits this product.

HAVRIX (Hepatitis A Vaccine)

Hepatitis A is an acute infectious disease of the liver caused by the hepatitis A virus (HAV).[1] The virus is primarily spread when an uninfected (and unvaccinated) person comes into contact with food or water that is contaminated with the faeces of an infected person. The disease is closely associated with unsafe water, inadequate sanitation

However, molecules do not behave in the same way during the development, scale-up or manufacturing phases. Customising single‑use bioreactors to make them suitable for processing the specific molecules defeats their key advantage of plug‑and‑play.

• Scale-up – The volume size (no more than 2000L) as well as the end of the product quality for large-scale manufacture is one of the main limitation for single use technology.

• Scale-down - Scale‑down studies are generally conducted to establish the potential root cause of any deviation that has occurred or to perform a risk‑based study. The lower limits in working capacity of the single‑use bag type or single‑use system is prohibitively high to conduct such studies.

• Mixing - Stirring is one of the key elements in a bioreactor system on which mass transfer and energy transfer depend on. The mixing principle in a single use bioreactor is limited to a movement which limits the use of the bags to low volume and simple applications such as the seed‑train expansion of