Purification Development Service
Creative Biolabs has extensive experience not only in developing and optimizing processes, but also in scaling up processes and transferring them to cGMP manufacturing in our facility. We are passionate about delivering the best service to fit our clients' requirements, and we work closely with you throughout the process development with consideration of reducing timeline and cost, as well as improving process performance.
Background
The fermentation processes that are used by biopharmaceutical manufacturers have shown an increase in the number of therapeutic proteins. However, this increase in turn leads to capacity bottlenecks in the subsequent purification process (known as downstream processing) and is associated with high costs. Downstream processing comprises up to 8 percent of the entire production costs. Producers are increasingly aware of the present need for improvement and have shifted their focus from improving the production process (upstream) to improving the downstream process.
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Fig.1 Workflow for the development of a purification process.
What We Can Offer
With insight gained from our own products, we have established downstream platforms that allow us to quickly enter a product's manufacturing phase. Our experience also enables us to develop more customized and innovative solutions to meet our customers' needs. We optimize our downstream processes to remove impurities and increase yields with minimal steps and optimal recovery, leading to cost-efficient manufacturing. For microbial processes, we can purify directly from harvest or refold proteins from inclusion body preparations. Our process development and analytical teams are fully integrated to ensure we achieve the product quality attributes.
| ● High-Throughput Process Development (HTPD) System | ● Robust DOE platform | ● Standardized Downstream Unit Operations and Platform Processes | |
| ● Chromatography Purification Optimization | ● Chromatography Resin Dynamic Binding Capacity Studies | ● Chromatography Resin Lifetime, Cleaning, and Aging Studies | |
| ● Clarification Development | ● Viral Inactivation and Virus Removal Filtration Development | ● Scale-Down Process Characterization for Viral Clearance Studies | |
| ● Scale-up | ● Risk Analysis and Cost-Benefit for Various Purification Process Unit Operations | ||
Purification systems
With the powerful capacity of over 4 different purification systems used for purification development, we ensure a timely and efficient solution for our clients. Systems include, but are not limited to:
| ● ÄKTAprocess | ● ÄKTA ready | ● ÄKTApilot | ● ÄKTA avant |
| ● ÄKTAexplorer | ● ÄKTAprime plus | ● Depth Filtration System | ● Ultrafiltration/Diafiltration System |
| ● Automatic Tangential Flow Filtration System | ● ÄKTA cross flow | ● Alfa Lava Centrifuge | |
How Creative Biolabs' service Can Assist Your Projects
Our Expertise in Downstream Purification
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Customer Reviews
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Complex Molecule Handling
Creative Biolabs' expertise in handling recombinant proteins expressed as inclusion bodies was invaluable. Their structural and biophysical analysis guided the refolding step, increasing our final active yield compared to our internal attempts. The clear POP made scale-up virtually seamless. - Jil*** W. -
Reduced Cost of Goods
The detailed resin lifetime studies provided by Creative Biolabs demonstrated that we could reuse our capture resin for 5 % more cycles than we initially budgeted for, leading to a substantial reduction in our long-term COGS. This detailed documentation provides peace of mind for future commercial manufacturing. - Tho*** P.
FAQs
How does Creative Biolabs' QbD approach reduce my project timeline compared to traditional methods?
Traditional purification relies on one-factor-at-a-time (OFAT) experiments. Our Quality by Design (QbD) approach uses a robust design of experiments (DOE) platform to simultaneously evaluate multiple factors, identifying the optimal process window faster and minimizing non-productive experiments. This focused efficiency typically shaves weeks off the process development timeline.
Can your Purification Development process handle novel, highly challenging molecules like complex recombinant fusion proteins?
Absolutely. Our deep expertise in structural and biophysical Characterization is specifically designed for complex molecules. We guide purification choices based on real-time structural data, effectively addressing aggregation and stability issues that conventional platforms often struggle with.
How to Contact Us
With years of hard work in recombinant protein and monoclonal antibody, Creative Biolabs is quite experienced in the technologies used in discovery and exploration. We provide flexible options for you. Please contact us for more details.
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