Process Development

Technology Transfer (as the first step in Process Development and Manufacturing)

Sponsor Transfer to QSV

Technology Transfer is a critical first step in communicating methods, assays and process information between the client and QSV's Project Team. The information allows QSV to verify and validate protocols where appropriate. Technology Transfer activities begin immediately upon execution of the process development or manufacturing agreement.

On-Site Participation

QSV encourages sponsors to take an active on-site role in technology transfer. This includes on-site visits by QSV project team members to the sponsor site to gather firsthand knowledge of methodologies. In kind we invite Sponsor project team leaders or members to take an active role by visiting QSV's facility during critical aspects of the technology transfer process. We strongly suggest that the initial team visit coincides with the project "kick-off" meeting. As the project progresses, QSV supports client visits and on site presence as the "man in the plant" model during critical phases of the manufacturing process.    

Technology Transfer process defines:

• Raw materials acquisition and testing.
• Product or raw material safety issues.
• In process and final release assay methods, qualification and validation data.
• Manufacturing processes and scale-up procedures. 
• Product specifications - in process and final release criteria.

QSV Transfer to Sponsor

Upon completion of the project, QSV prepares a Technology Transfer portfolio for the client. The processes developed and implemented by QSV become the property of the client. All process Intellectual Property or proprietary procedures developed during the course of the project are licensed to the client without royalty or additional payment.

Included in the Technology Transfer Portfolio:

• QC/QA methods and protocols including validation documentation
• Process procedures, protocols, methods and data
• Regulatory documentation and communication with regulatory agencies
• Batch records

Upstream Process Development

Upstream process development is defined as optimizing media, fermentation/cell culture seeding and large-scale cell densities, process feed and control parameters. The objective being to develop a cost-effective, scalable, robust, reproducible and compliant manufacturing process while maximizing expression. 

Downstream Process Development

Downstream process development is focused on optimizing final product yield, improving product purity and development of a sturdy, reproducible purification process. Special attention is paid to compliance and cost effectiveness of the final process.  
 
Analytical Development and Support

QSV provides analytical development services for in-process and final product release testing including sterility, purity, identity, potency, concentration, and stability for in-process and final product release.

QSV Dedicated Project Management Model

QSV assigns a dedicated Project Manager at the business development stage who actively participates in early discussions with the sponsor. The Project Manager is responsible for managing all aspects of communication and information flow between the client and QSV, serving as an information resource to our clients. 

Reporting to each Project Manager is a dedicated Process Development team of 6 -7 upstream and downstream development scientists. We currently maintian two distince Process Development teams. 

QSV's Project Managers are highly qualified scientists possessing hands-on process development and manufacturing experience with a high level of decision-making responsibility in cooperation with the sponsor. Our Project Managers assume personal responsibility and decision-making input. It is our belief that communication is key to a successful project outcome - responsive and rapid turnaround on critical decisions is essential.