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Downstream purification (downstream processing) is critical for therapeutic development and can be the rate-limiting step in biologic production. Increasing volumes of protein production upstream has the effect of simultaneously increasing the concentration of impurities that must be removed before final production of biologics. An efficient system of downstream purification therefore ensures the required purity and yield of a therapeutic, at a given scale.

 

Reliable downstream purification also provides batch-to-batch reproducibility. The choice of the right purification conditions and techniques may be the most critical component of the manufacturing process.

 

BioReliance offers years of expertise in cGMP compliant, downstream purification techniques. Contact one of our downstream purification experts to discuss your project in more detail.

 

How does downstream purification work?

The basic concept is to remove impurities in-line with recombinant protein or vaccine production typically through the use of Chromatography. The goal is to reliably produce compounds of high purity and activity.

Chromatography resins can purify therapeutics via a number of different separation chemistries including protein A binding to monoclonal antibodies or simple charge and size exclusion. Resin chromatography offers high capacity, throughput, and scalability for downstream purification projects and is a good “first choice” for many projects.

Membrane chromatography is a relatively new purification method that offers some distinct advantages over resin chromatography. Membrane adsorbers offer a large number of separation chemistries and are usually disposable, saving the cost of washing or cleaning.

BioReliance specializes in most chromatography techniques that are used in downstream purification under cGMP compliant conditions.  Our scale up services for downstream purification include:

• Selection of Membrane Technologies
• Cell Disruption (Sonication and Homogenization)
• Chromatography
• Affinity
• Ion Exchange
• Size Exclusion/Gel Filtration
• Hydrophobic Interaction/Reversed Phase
• Gradient Purification
• Centrifugation

BioReliance has performed hundreds of successful downstream purification projects. Contact us today for more information on downstream purification services.