Technology Transfer Services
It is essential in today’s competitive biologics markets to develop a robust, scalable, validated, and cost-effective biomanufacturing process. Whether you need assistance developing an entirely new process, improving existing processes, or preparing to scale up to clinical and commercial production, you will benefit from our bioprocess development expertise.
We have a very long track record of successfully transferring technology packages to support a wide range of biologics and clinical stages. Our core service is to ensure that the contracted activities are well aligned with each of our clients’ programs. All customer projects are tailored to match the required scope and specific clinical phase. In addition, our development team is experienced with fast and effective technology transfer to establish proven mammalian cell culture and microbial fermentation processes. The combined experience of our staff ensures that every customer will receive a seamless route for scale-up to cGMP and commercial manufacture.
- External Technology Transfer
- Facility Fit/Gap Assessment
- Risk Assessment
- Analytical Development Services
- Platform Assay Verification/In-House Assay Evaluation
- Analytical Method Transfer & MD/MV
- Upstream & Downstream Process Transfer Packages
- Pre-Formulation Activities and Stability Studies
- Non-cGMP Engineering Batches
- cGMP Production Runs
Process Characterization Services
In addition to your process development services, we also offer Process Characterization (PC) services to support product commercialization for in-house developed or previously established processes. Process Characterization studies are necessary to identify critical process parameters (CPPs), material attributes, control strategy, and design space. Essentially, PC studies will justify the operating ranges and process control strategy for the scale-up process.
Specifically we use a Quality by Design (QbD) approach for process validation (PV) and continuous lifecycle management. Our PC Department is seamlessly integrated with the PV Department in Manufacturing, which gives us the advantage to effectively design your entire manufacturing project to withstand fluctuations in batch sizes and improve overall process economics.
Process Characterization Key Services:
- Identification of Critical Quality Attributes (CQAs)
- Identification of Critical Process Parameters (CPPs)
- Scale-down model (SDM) qualification
- Unit operation(s) DOE studies