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Process Development

Building Robust, Flexible and Scalable Processes

Design. Develop. Optimize.

We have established an effective process development team and platform that can be tailored to meet your unique needs. Our job is to help you evolve from your current state to your desired future state.

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.

▸Quality-by-Design Strategy

▸End-to-End Solutions From Process Development to GMP Manufacturing

▸Analytical Development

▸ Platform Processes to Accelerate Your Program to the Clinic

▸Upstream Process Development

▸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.

Strategic Process Development is the Foundation for Successful Clinical Manufacturing

Ensure safety, yield and quality targets can be met consistently.

Align with product strategy and clinical manufacturing plan.

Tweak processes to minimize Cost of Goods Sold (COGS).

Confirm processes will support manufacturing scale.

Ensure safety, yield and quality targets can be met consistently.

Align with product strategy and clinical manufacturing plan.

Tweak processes to minimize Cost of Goods Sold (COGS).

Confirm processes will support manufacturing scale.

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The BioCentriq Team

The scientists, analysts and engineers in our process development group oversee, design, and execute experiments to develop and optimize processes for a variety of products.

They come to us from companies like BMS, Novartis, Merck, Legend Biotech, Pfizer and more.

LEARN MORE

“It’s very rewarding to know that my time in the lab is spent focused on the optimization of processes for therapies that will change lives.”

Gabriella Ciasullo

Senior Associate Engineer

FAQs About Our Process Development Capability

Our team works on a variety of cell therapy process development and optimization projects. We've worked on both allogeneic and autologous cell therapy products as well as optimizing processes to support both upstream and downstream processing. In addition, we work on process development projects that demonstrate the application of innovative and novel technologies provided by leaders in the industry.

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