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Downstream Process Development

Downstream process development focuses on yield and productivity as well as purity and process capabilities. Creative Biogene has established a well-established downstream process platform that enables the development of customized and innovative solutions to meet our customers' evolving downstream process production needs. By expanding existing facilities and optimizing existing and alternative processes, we can improve separation efficiencies for individual unit operations, resulting in more cost-effective manufacturing.

Downstream Process Development

Downstream Process Development (DSP) Services at Creative Biogene

The purpose of downstream processing is to isolate, purify and concentrate products from complex native matrices. During downstream process development, our scientists perform multiple unit operations for the removal of process impurities and the isolation and purification of target products. Creative Biogene is committed to providing innovative solutions in the following downstream processes:

  • Purification process development
  • Process Optimization and Scale-Up
  • Purification process characterization
  • Impurity analysis and removal
  • Virus removal study design
  • GMP batch production
  • Technology transfer
  • Regulatory support

Innovative Technologies for Downstream Process Development

Creative Biogene's experts will help customers select the right downstream process steps based on their production needs and combined with our experience and technology in downstream process development, transfer and scale-up. Our innovative technology platform and scalable filtration and purification solutions allow us to provide customized solutions for a wide range of molecules and efficient process development to address any challenge encountered in downstream process production.

TechnologyDescription
ChromatographyChromatography is a widely used method in downstream processes for the separation and purification of proteins based on their charge, size, hydrophobicity or affinity for the chromatographic resin. Crerative Biogene can provide and screen different types of chromatographic methods such as Ion exchange chromatography (IEX), size exclusion chromatography and affinity chromatography depending on the customer's production demands.
Ultrafiltration and diafiltrationUltrafiltration and diafiltration are methods that use semi-permeable membranes to achieve separation based on size. Our scientists use these methods for concentration, buffer exchange and virus removal during downstream processing.
Tangential flow filtration (TFF)TFF is a method of separating particles and molecules based on their size and shape. Creative Bogene provides efficient separation and purification through Tangential Flow Filtration (TFF) technology in downstream processes including cell collection, clarification, perfusion, wash filtration and concentration to ensure consistent delivery of high throughput sample processing and recovery.
Viral clearanceTo ensure product safety, virus clearance is a critical step in the development of downstream processes for biologics. Creative Biogene offers a variety of effective methods for virus removal, including solvent-detergent treatment, nanofiltration, and low pH treatment.

Creative Biogene as a leading CDMO manufacturer, is committed to helping our customers optimize their downstream processes to remove impurities and increase yields with the fewest steps and best recovery rates, resulting in more cost-effective manufacturing. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.
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