High Containment Biologics Manufacturing

Our high containment biologics operations handle highly infectious and/or potent agents through a controlled manufacturing system through the use of BSL-3/BSL-2 infrastructure with a capability for closed system processing.

We currently have multiple processing suites and supporting infrastructure, including a dedicated process development suite and CDC Tier 1 select agents. For each biological agent introduced, aggressive assessment studies are performed to ensure there is no contamination.

Our analytical testing labs are furnished with appropriate equipment such as safety work benches for sample preparations, containment hoods and isolators, and separation from the normal lab areas and with limited access.

BioMARC complies with all applicable laws with respect to the environment, occupational health and safety, public health and safety, and waste disposal, and holds all current and applicable governmental licenses, approvals, permits and authorizations.

The graph below represents the appropriate regulatory framework applied at each stage of development, ensuring regulatory compliance and reasonable cost.

Graphical representation of appropriate regulatory framework applied at each stage of development

Continuing Improvement

“Continuous improvement in safety never ends” is a dictum at BioMARC that fully applies. As part of our continuing efforts to strengthen our safety program at BioMARC, we have identified several key additions to the program as near term goals:

  • Commencement of a “Near Miss” program to preemptively identify potential hazards before escalation to an incident.
  • Continuous training updates and briefings with an emphasis on the adoption by employees of a responsible attitude in their daily work.
  • Quarterly workshops for senior research personnel to review current accepted best practices and discuss ways to enhance or improve BioMARC current practices.
  • Analysis of the potential for a “Prevention through Design” Program throughout all aspects of BioMARC (Bio)safety operations.  See: Center for Disease Control & Prevention  

High Containment BioMARC Biosafety Policy

Safety is the number one priority at BioMARC.

We are committed to…

  • Promoting responsible use of chemical and biological materials to ensure the health and safety of our employees, the wider community and the environment.
  • Developing, implementing, and supporting a broad and rigorous set of safety procedures and practices in alignment with CSU’s EHS and Biosafety departmental policies.
  • Providing training and access to safety resources to the benefit of BioMARC employees.
  • Fostering and maintaining a culture of safety to ensure a safe and healthy workplace.
  • Providing the infrastructure necessary to achieve a high level of safety and security of our chemical and biological materials.
  • Establishing and documenting scientifically sound practices with regards to the use of chemical and biological materials.
  • Being transparent in our approach to safety.

We achieve and maintain an exceptional safety record through the following procedures & practices:

  • Developing manufacturing and research procedures that minimize health risks to personnel, the wider community and the environment.
  • Hazard identification through risk assessment and mitigation activities
  • Perform routine safety audits to ensure compliance with regulatory requirements and objectives.
  • Work in partnership with CSU Biosafety, CSU EHS and other regulatory agencies.
  • Promptly respond to employee or community concerns on safety issues and make every effort to resolve them.

Personnel Training

  • BioMARC provides consistent and appropriate-level training for all employees in the safe handling and storage of chemical and biological materials.
  • Employees receive additional task and project specific training on the risks inherent to their roles as well as the potential broader environmental impacts associated with these activities.
  • A periodic assessment of personnel proficiency in the practices and procedures is required in the high containment area.
  • The Environmental Health and Biosafety Coordinator of BioMARC is charged with identifying hazards, establishing safety practices, and managing the training of staff with regard to safety making safety recommendations to the Director of BioMARC.