Pre-Clinical Manufacturing

QSV Biologics has the capability to produce non-GMP pre-clinical materials for animal and toxicology studies. Materials destined for pre-clinical studies do not require implementation of full cGMP manufacturing procedures since they are not to be used in human trials. Pre-clinical materials may be manufactured in a GLP or cGMP environment as determined by equipment location or availability, required quantity or other product-related criteria. These products are manufactured with the same quality and care as cGMP products for human trials although complete cGMP documentation is not provided.

Pre-Clinical Production in Process Development

It is common practice for sponsors to use materials derived from Process Development projects for pre-clinical testing. All materials produced during development work are the property of the sponsor and will be delivered to the sponsor upon request. Depending on the stage of product development or product characterization, release specifications and criteria will be detailed in the Process Development Scope of Work Agreement.

QSV provides assistance in clone selection and development of a suitable upstream and downstream manufacturing process for the production of pre-clinical materials. The primary objective is producing sufficient quantities of pre-clinical materials meeting mutually agreeable specifications, therefore limited process development work will be applied unless specified by mutual agreement. Cell lines entering QSV must first be tested for presence of adventitious agents.

QSV offers the following services for pre-clinical manufacturing:

• Clone selection
• Process Development – upstream and downstream
• Analytical Development
• Scale up