Entry Level Scientist- Viral Clearance

Viral Clearance Services:

Background:  Bio/pharmaceutical products cannot be marketed or utilized in clinical trials without first establishing that the manufacturing process is capable of removing potential viral contaminants from the finished product.  Viral Clearance Services provides assurance to the pharmaceutical industry that the risk is minimal in exposing a customer to a viral contaminated product.

What do we do:  The department deliberately introduces virus into client product intermediates and then measures the ability of the process purification step to remove or inactivate that virus.  Multiple steps in a client purification process can be assessed to achieve a cumulative clearance value for a purification process.  The testing is designed to satisfy requirements established in the ICH Q5A guidelines.  Testing is generally looking for presence/absence of virus plaque forming units (PFU) and comparing the amount of virus that was initially in the sample to the amount of virus in the product containing fraction after the purification has been completed.  The Log10 difference between initial titer and the product titer is referred to as a Log Reduction Value.

Center of Focus: 

• Virus plaque assays – team members perform cell culture manipulation and virus sample dilutions to yield results of the purification process.
• Client purification process – team members assist client in performing their viral clearance study by spiking client sample intermediates with virus for their performance of their purification step.
• Performance of purification processes – team members perform the client purification processes instead of the client being on site to perform them.
• Virus stock preparation – team members perform cell culture manipulation and virus stock propagation to create more virus banks and to improve the titer / purity of virus stocks.

Instrumentation and testing techniques:  AKTA Chromatography systems, Biological Safety Cabinets, Microscopes, and various Laboratory Equipment (including hotplates, balances, pH meters, shakers, electronic pipettors, water baths, centrifuges).  Continuing investments are made to on-board new technologies for new service offerings and to meet client needs.

Additional Responsibilities:

Completing all training in a timely and complete manner; working with an experienced analyst/mentor performing various tasks and analyses of Bio/pharmaceutical ingredients and products; reviewing or preparing standards and samples for analysis and running any equipment or instrumentation independently and/or with guidance; working efficiently; ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations.