What is Downstream Bioprocessing?
Learn more about how solutions created during upstream bioprocessing are separated into the target material through downstream bioprocessing.
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What is Downstream Bioprocessing?
Downstream bioprocessing has the ultimate goal of separating, purifying and producing a target product from the mixture created in upstream bioprocessing.
Steps in Downstream Bioprocessing
Like upstream bioprocessing, downstream bioprocessing can be broken down into a variety of smaller steps. These steps may change depending on the specific goals of the process, but four main steps are separation, cell disruption, purification, and concentration.
Separation
Now that you have reached your desired cell volume through upstream bioprocessing, the first step of downstream bioprocessing is separation, in which we start to separate the fermentation broth or cell culture broth from the insoluble ingredients like microorganisms or cells.
There are several methods to complete separation, including precipitation, centrifugation, filtration, and chromatography. At High Purity New England (HPNE), a leading manufacturer of biopharma solutions, they carry a range of effective chromatography systems from BIA Separations that are ideal for the separation stage of your bioprocess.
Their Preparative Monolithic Chromatography Columns eliminate packing, unpacking, and repacking from your downstream purification process, and come in a range of scalable volumes from 1mL to 40L. Manufactured with epoxy thermoset materials and reinforced with carbon fibers, they have a high viral binding capacity & low shear stress.
Purification
During purification, it is time to start removing any impurities that could potentially be present after isolating the product in separation and cell disruption. Although the degree of purity needed can change from situation to situation, in general, you want to strive for a high level of purity, as it is often crucial to the safety of the final drug product.
As with the other steps, purification can be conducted through a variety of methods including filtration, crystallization, membrane purification, distillation, and chromatography.
For membrane purification, tangential flow filtration (TFF) is a frequently used method. High Purity New England carries a range of efficient and innovative OptiMaxx Tangential Filtration Systems, with four scalable sizes in order to accommodate benchtop to full-scale manufacturing applications.
The Analytical Monolithic Chromatography Columns at HPNE can also be an ideal solution at this stage, as they were primarily designed for final control and in-process of various samples throughout different stages of the purification process.
Concentration
After removing any impurities from the solution, sometimes excess fluid remains. To separate the cell needed for the final product, your remaining solution from the purification step must go through a concentration process. This usually involves ultrafiltration, where the solution is passed through a semipermeable membrane, letting extra fluid pass through to the permeate side of the membrane, leaving the product remaining on the retentate side.
Depending on the size of your protein, enzyme, or microorganisms, microfiltration may be a viable step as well. Once you have completed the concentration step of downstream bioprocessing, you are ready to move on to formulation and fill-finish, which will be discussed in a further article.
Downstream Bioprocessing at HPNE
High Purity New England (HPNE), a leading supplier in bioprocess solutions, sells a variety of products that are applicable in downstream bioprocessing.
HPConnexx™ Single-Use Assemblies, which are manufactured in the ISO Class 7 Cleanrooms at HPNE feature fast lead times, no minimum order quantities, and brand agnostic designs. With years of combined industry experience across their expert team, and extensive material compatibility resources, HPNE is equipped to develop the perfect assembly for your unique process every time.
In addition to their single-use assemblies, High Purity New England carries a range of single-use components that can be useful throughout the downstream bioprocess, like Single-Use Bottles and Custom Fabricated Components.
Other Applications in the Bioprocess
From drug discovery to fill-finish, High Purity New England has the capabilities to provide the perfect solution for every step of your process. Learn more about their specific upstream bioprocessing applications in our previous article, “What is Upstream Bioprocessing”.
To start exploring solutions that may be useful for your process, talk to one of their experts at info@hp-ne.com.
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About HPNE
As the industry needs grow, High Purity New England, Inc. continues to supply the biopharmaceutical industry with a range of innovative products, from drug discovery and development to fill-finish, including their flagship product, custom single-use assemblies, as well as pumps, sensors, bioreactor systems, storage and handling solutions and other single-use solutions. Along with their own manufactured products for the global market, they are also a distributor for more than 18 brands in North America.
