Virus Contaminations in Biomanufacturing
Virus contaminations are an industry-wide threat. The CAACB addresses these potentially devastating events through a project designed to uncover trends in the field.
Detailed information was first collected from member companies through a comprehensive questionnaire and then the findings were analyzed in terms of risk to the industry. The results were compiled and distributed to provide companies with knowledge that might help them mitigate risks in the future.
Effectiveness of Media Treatment Technologies
The CAACB became involved with an ‘Evaluation of Media Treatment Effectiveness’ when they became aware that a database of virus inactivation or removal from media for HTST, UV-C and nanofiltration technologies does not exist. The CAACB is attempting to address this lack by assembling and analyzing existing viral inactivation and removal data for media treatment from literature and confidential data from member companies. The goal is to gather this information into a single source that could be useful to the industry.
Economic Analysis of Media Treatment
The project ‘Economic Analysis of Media Treatment Technologies’ surveyed technologies capable of inactivating or removing viral agents in cell-culture media. The development and implementation of these technologies has an impact on cost of goods, and the CAACB reviewed cost estimates for barrier technologies and designed a tool to estimate the expense of implementing such technologies.
Risk Assessment and Risk Control
The goal of the ‘Risk Assessment and Risk Control of Virus Contaminations in Biomanufacturing’ project is to compile a Virus Contamination Risk Assessment and Risk Control handbook. This guide could be used to aid companies in their risk assessment and management process while also helping scientists, engineers, and quality risk control personnel to assess the risk from viral contaminations. It should also facilitate general communication around methods that can be used to handle such events.
Facility Segregation for Viral Safety
It is critically important for manufacturers design facilities to prevent contamination events and to contain one if such an incident were to occur.
Consistent practices or regulatory guidance on best approaches to facility segregation are currently lacking. The guidance that does exist is weakened by vague terminology. However, regulators expect appropriate segregation and justifications for that segregation, and the CAACB is attempting to help industry meet those requirements.
The goals for this project are to: 1) reach a consensus on the definition of common terms, such as “functionally closed” and “pre/post viral clearance”; 2) identify an array of facility segregation approaches that are adequate and appropriate depending on the manufacturing facility and situation; and 3) communicate these items to the industry through presentations and peer-reviewed publications.