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Quality Risk Management for Filter Integrity Testing: Compliance with EMA’s Future Annex 1

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Quality risk management (QRM) is a systematic process for assessment, control, communication, and review of risks to the quality of a pharmaceutical product across its lifecycle. Although QRM is not new (1), the regulatory focus on QRM will increase with the arrival of the European Medicines Agency’s (EMA’s) Annex 1 (2), which was reviewed by the US Food and Drug Administration (FDA), the World Health Organization (WHO), and the Pharmaceutical Inspection Convention Scheme (PIC/S). Integrity testing of sterilizing-grade filters is…

October 29, 2020

Technology to Transform AAV Manufacture

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Adenoassociated virus (AAV) vectors are a popular choice for modern gene therapies because of their favorable safety profile, low immunogenicity, and the ease with which they can be transduced into different cell and tissue types. An AAV genome is a single strand of DNA comprising a replication (rep) gene, which encodes regulatory proteins involved in genome replication, and a capsid (cap) gene, which produces three capsid proteins. However, AAVs cannot replicate alone. In nature, AAV shares an exquisite relationship with…

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 5Í´-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

Advantage of Antibody-Based Selectivity in the Purification of Next-Generation Biologics

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The webcast features: Laurens Sierkstra, Senior Director, Business Leader Purification, Thermo Fisher Scientific Advances in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges. Affinity chromatography can serve as a platform solution for the purification of these challenging molecule modalities. An effective affinity resin can help to simplify biomolecule purification, reduce the number of purification steps, and reduce the overall cost of goods in biotherapeutic manufacturing. By taking advantage of antibody-based selectivity, camelid…

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

Endotoxin Questions and Answers

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Endotoxin — also known as lipopolysaccharide (LPS) — is a large molecule made up of a lipid and a polysaccharide portion found in the outer membrane of each Gram-negative bacterial cell. Examination of endotoxins is necessary for microbial and animal cell-culture operations that produce active pharmaceutical ingredients (APIs) and vaccines. If a cell culture is contaminated with endotoxins, it could affect cell growth and function (thus potentially affecting product quality). Biopharmaceutical companies need to understand the endotoxin levels within their…

October 29, 2020

Ask the Expert: Mass Spectrometry for Relative and Absolute Quantitation of Process-Related Impurities

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Qualitative and quantitative analyses of process-related impurities are critical to manufacturing a safe, high-quality drug product. During his 17 June 2020 “Ask the Expert†webcast, Steven Broome (BioPharmaSpec) described using mass spectrometry (MS) for such analyses. Focusing on isopropyl-β-D-thiogalactopyranoside (IPTG), kanamycin, and host-cell proteins (HCPs), Broome overviewed best practices for using MS to detect and quantitate low levels of impurities. Broome’s Presentation Chemicals used in biotherapeutic production can be present as impurities in the resulting drug product. These impurities can…

October 28, 2020

Enabling Increased Performance, Robustness, and Safety in Single-Use Bioreactors

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This webcast features: Lara Nascimento-Brooks, Product Manager, Sartorius Stedim Biotech The discussion will focus around three relevant themes for bioprocess development on single-use bioreactors: performance, robustness, and safety. An initial overview of the current landscape developments in the biopharmaceutical industry highlights that bioprocesses should remain flexible enough in order to accommodate intensification and reduce further time-to-market. With this in mind we will discuss key aspects of bioreactor performance improvement in order to achieve that goal. Additionally, processes must remain sufficiently…

October 28, 2020

Aggressive Microbial Production from Inoculation Through Harvest in Single-Use Systems

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This webcast features: Dmitrij Bugajev, R&D Scientist, and Jason D. Brown, Design Engineer, Thermo Fisher Scientific Single-use fermentors enable production facilities to utilize single-use technologies instead of traditional stainless-steel fermentor vessels, achieving equivalent expression with rapidly growing high-density cultures. In this webcast, we will compare some results from various processes with yeast and bacteria before and after technology transferred to single-use at our two facilities. We will give you our feedback as previous end users of stainless-steel fermentors and now…

October 23, 2020