Our team leverages deep expertise in process and analytical development to establish and scale up processes that achieve optimal yield and cost efficiency based on sound science, engineering, and cGMP design.
We take a team with vast experience across a wide range of technologies and modalities and place them in state-of-the-art facilities with leading edge process technologies with access to partners in MS&T and manufacturing to ensure that the work they do will be GMP ready.
Why BioCentriq for Process Development?
- Senior scientists and engineers offer depth & breadth of experience.
- Hybrid model provides option for your team to work alongside ours.
- Engaging MS&T and manufacturing early ensures GMP readiness.
BioCentriq's Approach to Process Development
We start every process development project with a careful review of all your documentation to date and a feasibility study followed by a detailed gap assessment, and we move on from there based on the unique goals of your program.
After knowledge transfer of the existing process, our team employs a Quality-by-Design product strategy to advance and scale up the process to one that is robust, phase-appropriate, and commercially viable.
End-to-End Solutions From Process Development to GMP Manufacturing
We can work with you to develop the various component processes required to produce your novel therapeutic product, such as cell banking, vector production, upstream/downstream processing, formulation, fill and finish, analytical testing, and product/process characterization.
Our analytical development team provides comprehensive custom assay development services to ensure effective product and process characterization. We also have pre-established standard assays available to fast-track your method development.
Platform Processes to Accelerate Your Program to the Clinic
Our proprietary production platforms for cell & gene therapy technologies can serve as a launching pad for developing an efficient and scalable manufacturing process for your novel therapeutic.
Upstream Process Development
Our upstream process development facility is equipped with production systems across the range of scales and modalities to facilitate optimization and scale-up of your upstream processes. The lab is outfitted with adherent and suspension bioreactor systems that cover a range from 10mL to 50L and can support fed-batch and perfusion processes.
Downstream Process Development
We have established downstream systems and workflows that can accelerate the characterization of our clients’ processes and products. Our process development and analytical method development groups work closely every step of the way to ensure early and proper identification of your product’s quality attributes and critical process parameters. Our team possesses the expertise to optimize downstream purification of your novel drug product. We work closely with you to establish a custom purification scheme that is optimized for quality and yield based on the unique characteristics of the target product.