Gibco® Bioprocess Services uses a customized process for executing upon your programs for cell line development, process development, media optimization, and more. A dedicated Gibco® Project Manager will be assigned to your program and will serve as your point of contact throughout your program.
The diagram below shows how we customize each program to your needs. Click on the flowchart below to find out more about each phase.
The first phase of a project is the initiation phase. The initiation phase begins once the signed Master Service Agreement (MSA), Statement of Work (SOW) and Purchase Order (PO) have been received from the client.
The Project Manager assigned to your program will conduct the Kick-Off Meeting with your team. We will review the Gibco® Project Management philosophy, discuss the communication plan, and review goals, deliverables and project scope. At the Kick-Off Meeting, you will be introduced to your Gibco® Project Team, and we will review the roles and responsibilities of this team, consisting of the following members:
- Project Manager: serves as the main point of contact for the client and also manages scope, timelines and budget
- Process Science Fellow: leads development of technical proposals with the client; acts as project consultant
- Business Development Manager: provides business/contractual functions
- Project Director: provides oversight of all technical aspects of the project; reviews proposals, study plans and reports
- Technical Lead: prepares study plans and reports; oversees lab execution and presents data updates at client meetings
The client has the option of having their Kick-Off Meeting at Invitrogen. After the Kick-Off Meeting is concluded, a member of the Gibco® project team will give a guided tour of Gibco® Labs.
The purpose of the Initiation Phase is to establish communication amongst the project team.
Once the project has progressed through the Kick-Off Meeting with the client, the project enters the planning phase. This involves the creation of the following plans:
- Project Plan: a project plan, including a Gantt chart, is created in detail outlining the activities, tasks, dependencies and timeframe for each phase and for the entire program
- Resource Plan: lists the labor, equipment and materials required (capacity planning)
- Risk Plan: the Gibco® Project Team will evaluate any potential risks and their impact on the timeline upfront and discuss with you a mitigation plan to move the program forward
- Acceptance Plan: for each phase within the program, a study plan (a detailed document of how the study will be performed) is written and agreed upon prior to initiation of the study
- Communications Plan: we will hold regular update meetings with the client to provide status and timeline updates and to review any study plans that are upcoming
At this point, the project is planned in detail and is ready to be executed.
These Project Management documents are tools that are created to plan for project success.
The objective of the execution phase is to ensure that the plans described above are properly executed. Execution may also involve quality assurance management. Each study is initiated with a study plan, which is approved by the client, and completed with a summary report. The Gibco® Project Manager ensures that the assigned activities are being carried out on schedule by the responsible resources. This includes identifying changes, risks and issues, reviewing deliverable quality and measuring each deliverable produced against the acceptance criteria. Once all of the deliverables have been produced and the client has accepted the final solution, the project is ready for closure.
Alignment with customer expectations is a key objective of the Execution Phase.
Monitor and Control Phase
Project performance must be monitored and measured regularly to identify variances from the project plan. A project may require a change in an objective or deliverable. Therefore, the project objectives and deliverables must be clearly defined to manage the project scope. Some of the processes that may occur during the phase are:
- Scope Change Control
- Risk Monitoring and Control
- Performance Reporting
We will work closely with the client to resolve any changes that may take place during the program.
Once the scope, data and solutions have been approved by the client, we are ready to close out the program. Program closure involves the following:
- We will verify with the client that the scope of the program was met
- We will release all final deliverables to the client, including materials that may have been generated during the program and all study reports
- The Business Development Manager will perform a one-on-one "lessons learned" exercise with the client so that we can better understand our client needs and to help us improve upon science and communication
We look forward to meeting you and kicking off your program!
Vector/Cell Line Development
Custom designed and optimized protein and virus expression systems using your cell line. Learn more about Vector and Cell Line Development
Establish scalability and robustness of your process for transfer to cGMP manufacturing. Learn more about Scale-up and Tech Transfer
FreeStyle™ MAX System: a breakthrough technology for large-scale, rapid generation of proteins. Learn more about Transient Transfection
Assess titer and product quality and evaluate media stability more quickly and reliably. Learn more about Assay/ Analytical Development
Medium and feed optimization, platform creation, and media analytical services to optimize your process. Learn more about Process Development
Access to cGMP facilities for production and testing, as well as Gibco® bulk media manufacturing. Learn more about Manufacturing Solutions