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Process Analytical Development

Building Robust, Flexible and Scalable Processes
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Design. Develop. Optimize. 

We have established an effective process analytical 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 MSAT and manufacturing to ensure that the work they do will be GMP ready.

Why BioCentriq for Process Analytical Development?

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Senior scientists and engineers offer depth & breadth of experience.
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Hybrid model provides option for your team to work alongside ours.
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Engaging MSAT and manufacturing early ensures GMP readiness. 

BioCentriq's Approach to Process Analytical Development

We start every process analytical 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.  

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..  

Our proprietary production platforms for cell therapy technologies can serve as a launching pad for developing an efficient and scalable manufacturing process for your novel therapeutic.
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.  
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 Analytical Development is the Foundation for Successful Clinical Manufacturing

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Ensure safety, yield and quality targets can be met consistently.
Virtual Instructor Led Training

Align with product strategy and clinical manufacturing plan.​

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BioCentriq Self-Paced Training Courses

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

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Confirm processes will support manufacturing scale. ​
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Ensure safety, yield and quality targets can be met consistently.
Virtual Instructor Led Training

Align with product strategy and clinical manufacturing plan.​

​

BioCentriq Self-Paced Training Courses

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

Image
Confirm processes will support manufacturing scale. ​
    CONTACT US

    The BioCentriq Team

    The scientists, analysts and engineers in our process analytical 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.

    “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.”
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    Mary Loveras

    Director, Head of MSAT
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    FAQs About Our Process Analytical Development Capability

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