Chromatography

eBook: Ion-Exchange Chromatography for Modern Biopharmaceutical Purification

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Understanding the functionalities of chromatography resins can improve the product yield and purity in a biotherapeutic purification workflow. Ion-exchange (IEX) chromatography separates biomolecules on the basis of charge. For several reasons, it is the most widely used separation tool for purification of biopharmaceutical products. IEX is a well-characterized purification method with high binding capacity and flexible selectivity. It also works with mild operating conditions that help to preserve the biological activity of a biopharmaceutical drug substance. That versatility enables several…

December 18, 2020

Streamlining Industrial Purification of Adeno-Associated Virus

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With its first licensed therapeutic now marketed worldwide (1), adeno-associated virus (AAV) has become a preferred vector for gene therapy. However, unlocking its full potential still poses challenges, many of which are associated with purification. The first involves the transition from upstream to downstream processes. AAV-bearing lysates are laden with debris that foul filtration media and limit or prevent concentration. Another challenge involves reduction of soluble host-cell DNA, which is complicated by its strong association with nucleoproteins. A third involves…

December 17, 2020

Exploring Resin Modalities for Biotherapeutic Purification

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New chromatography supports must demonstrate improved selectivity, and bead technologies must be optimized for high binding capacity and product recovery. Drug manufacturers also need access to expertise and continued support from chromatography suppliers that can assist with method development and design of experiments (DoE) assessments. Working together, these industry groups can accelerate method development, increase process yield, reduce buffer consumption, minimize the number of unit operations, and improve overall process economies. Learn more in this Special Report about how resin…

December 9, 2020

A New Runway for Purification of Messenger RNA

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A high-performing capture method is a critical bedrock asset for developing industrial purification processes. This is especially true for extended families of products that share highly similar chemical composition. Therapeutic monoclonal IgG is an example. The ability of protein A affinity chromatography to achieve 95% purity in one simple step was the runway that got recombinant immunotherapy off the ground and made it available to millions. In fact, protein A did more. Beyond giving the industry a foundation manufacturing method,…

October 29, 2020

Dye-Stripping Buffer and Resin Stripped-Dye Analysis: Development and Optimization of a Novel Spectrophotometric Assay and Method for Removal of Cibacron Blue Dye

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Biopharmaceutical process-related impurities encompass all organic and inorganic materials that arise from the biomanufacturing process apart from the drug substance. According to ICH Q6B guidelines on test procedures and acceptance criteria for biotechnological products, these impurities include cell substrates such as host-cell proteins, host-cell DNA, endotoxins, and so on; inducers, antibiotics, media components, and chromatographic media used in purification processes; and solvents and buffer components (1). Impurities can cause undesired, deleterious pharmacological effects if ingested or injected by a patient,…

October 29, 2020

Streamlined Polishing and Viral Clearance Using a New Hybrid, Biomimetic, Single-Use Anion Exchanger

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Flow-through anion-exchange (AEX) chromatography is used frequently in biopharmaceutical purification processes for reduction of net–negatively charged host-cell proteins (HCPs) and viruses as part of a validated viral clearance strategy (1, 2). AEX column chromatography is the technology most often used for electrostatic viral clearance, particularly in commercial-scale biopharmaceutical manufacturing, for which columns have a long-established history of reliable and well-understood performance (3). Still, validation of HCP and viral clearance by AEX columns in biopharmaceutical processes involves complexities that contribute significantly…

October 29, 2020

Simple and Effective Method for Purification of DMT-On Oligonucleotides Using HIC Resins

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Within the biopharmaceutical industry, oligonucleotide drug pipelines have increased significantly because of the effectiveness of such drug products in treating devastating diseases. Downstream specialists need improved purification techniques for such highly valuable materials. Dimethoxytrityl (DMT) is used to synthesize oligonucleotides and temporarily mask the characteristic chemistry of the 5ʹ-hydroxy functional group. DMT can be left on an oligonucleotide following synthesis to provide stability to a molecule during subsequent processing. Herein, we describe a novel, effective, and high-recovery method for purifying…

October 29, 2020

eBook: Mixed-Mode Chromatography for Purification of Biopharmaceuticals

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Mixed-mode chromatography offers several advantages in downstream processing of biotherapeutics. Mixed-mode chromatography resins use ligands that are capable of at least two modes of interaction with solutes such as hydrophobic, ion exchange, and metal affinity. The interactions between stationary and mobile phases that result from those combinations enhance chromatographic selectivity, facilitating separation efficiencies that are not possible using other chromatography media. As this eBook illustrates, the multimodal approach can save developers time and money by enabling robust purification of biopharmaceuticals…

October 29, 2020
challenges with exosome therapy

eBook: Challenges in Industrial Process Development of Exosome-Based Therapies: Characterizing and Managing Diversity

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The traditional classification of extracellular vesicles (EVs) includes three types: exosomes, microvesicles, and apoptotic vesicles. Each type arises from a distinct origin and exhibits distinct characteristics. The problem is that their size ranges overlap and that the major surface proteins presented by exosomes also are present on the surfaces of microvesicles and apoptotic bodies. This makes it a challenge for process developers to identify the vesicle fraction that best serves a particular exosome therapy. Anion-exchange chromatography (AEC) can fractionate EVs…

August 25, 2020

Discover, Develop, Deliver

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Astrea Bioseparations is the only adsorbent supplier that can discover new affinity ligands designed to bind selectively to a molecule of interest or specific impurity, develop efficient purification adsorbents and downstream methods, and deliver industrial-scale adsorbents (up to 1,000-L batch sizes) as loose slurry or in good manufacturing practice (GMP)-ready columns. With over 30 years of experience in development of affinity products and design and manufacture of new custom adsorbents, Astrea Bioseparations is a world leader in its field. The…

June 10, 2020