Optimizing recombinant protein manufacturing with advanced solutions.
Recombinant proteins are manufactured using microbial (E. coli) expression systems. Multiple protein expression, aggregation, and filtration steps are required to yield protein-based therapeutic substances such as insulin, erythropoietin, and enzymes.
From upstream to downstream purification, through final fill, Avantor® partners with your team to help you achieve reliable results. We combine our extensive experience with a broad range of products that include cGMP fermentation materials to support cell growth, excipients, chromatography media to aid in recombinant protein purification, and single-use solutions to maximize the productivity of your bioprocessing systems.
Avantor® is well positioned to meet the critical challenges of companies developing and manufacturing next generation solutions to solve global health challenges – including GLP-1.
Whether your fermentation media are animal-based materials or “animal-free,” our fermentation products — such as Avantor J.T.Baker® IPTG used during microbial fermentation to induce the expression of recombinant proteins — support cell growth and productivity while meeting the required quality and performance parameters. We also provide centrifuges and reagents for primary recovery, concentration, and clarification process steps.
Our industry-leading Avantor J.T.Baker® brand buffer product line and J.T.Baker® brand BAKERBOND™ chromatography resins, including the BAKERBOND® PROchievA™ recombinant protein A resin, are trusted for high performance in recombinant proteins manufacturing. Backed by more than four decades of chromatography experience, we also provide downstream optimization services, including:
Avantor offers the required finished packaging vials and stoppers you need to progress from the drug substance to the final injectable drug product. We also carry an industry-leading excipient product line, including stabilizers and preservatives that meet stringent internal and external quality requirements.
Scale your recombinant protein production using our single-use components, assemblies, and systems. Our technical experts can collaborate with you to customize products to meet the specifications needed for your application.
Maintaining aseptic conditions during the manufacturing or down packing process is part of managing your risk. We offer products from industry-leading manufacturers and support from our teams of specialists who have the technical and industry experience to recommend the best solutions to meet your needs.
At Avantor, we have a deep understanding of bioprocessing workflows and regulatory environments. Our global distribution network and wide range of services can help you develop more efficient recombinant protein manufacturing processes. We deliver high-quality products with our streamlined purchasing experience. Our commitment to quality and innovation is proven and emphasized at every scale, making us a trusted partner.
Recombinant proteins are artificially made in a laboratory using recombinant DNA technology. Cells are typically transfected with a DNA vector, cultured to transcribe and translate the protein, lysed, and purified. There are various ways to complete recombinant protein purification to maximize protein yield.
Advances in recombinant protein technology and research have expanded the applications of recombinant proteins to include their use as diagnostic reagents, therapeutics, and vaccines.
Proteins are the result of the expression of DNA. Recombinant proteins are the result of the expression of recombinant DNA (rDNA) within living cells. Laboratory methods used to construct recombinant DNA combine at least two DNA fragments from different sources. The recombinant DNA is then inserted into a vector and allowed to replicate inside a living cell.
Recombinant proteins are manufactured using microbial (E. coli) expression systems. They represent a group of smaller protein molecules that include cytokine (erythropoietin or EPO), growth factors (insulin), and enzymes (Urokinase), among others.
Target proteins are secreted intracellularly using E. coli expression systems and may be challenging to recover. These insoluble proteins, along with other contaminants, are in inclusion bodies within the bacterial cytoplasm. Lysing the bacteria causes them to release the insoluble inclusion bodies.
After the proteins are solubilized and isolated, other mechanical and chemical additions allow proper protein folding. That results in biologically active proteins. Recombinant protein purification utilizing chromatography steps is comparable to that used for other biologics.
A wide range of recombinant proteins is produced using microbial (E. coli or yeast) fermentation – often being the preferred production method to drive efficiencies in the production process and to be faster to market.
The microbial process offers a lot of advantages – it is a safe expression system, and it allows for rapid and cost-effective development and production, while ensuring product quality and reproducibility.
However, some challenges remain, such as inconsistent protein expression during the microbial fermentation process, or the need to purify inclusion bodies with high-level expression or recombinant proteins leading to the formation of protein aggregation.
Avantor’s J.T.Baker® brand offers the only cGMP manufactured IPTG to ICHQ7 standards. That provides biopharma researchers and manufacturers with a solution to help scale recombinant proteins from research and development to clinical and full-scale manufacturing with speed, quality, and confidence.
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