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Industrialize Your Viral Vector Production in Adherent and Suspension Cell Cultures: Know the Pros and Cons

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This educational podcast, “The Evolution of Culture Systems for Viral Vector Production: Advantages, Challenges and Cost Considerations,†recently published by Cell and Gene Therapy Insights, discusses in detail the pros and cons of viral vector production in adherent and suspension cell culture. This special report illustrates how Pall Biotech’s iCELLis 500+ bioreactors and Allegro STR bioreactors can bolster adherent and suspension culture, respectively, for viral vector production. Fill out the form below to read the complete report and learn more now.…

May 11, 2020

Accelerating Vaccine Development By Innovative Purification Solutions and State of the Art Quality Testing

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This webcast features: Sirat Sikka and Florian Durst, Field Application Scientists (Purification and Pharma Analytics), Thermo Fisher Scientific The emergence of new diseases and infections has entailed the need for rapid and efficient development of safe and efficacious vaccines. Additionally, no effective vaccines currently exist for long-known pandemic diseases such as HIV or malaria. To address the challenges the vaccine industry faces, new vaccine modalities such as viral vectors, recombinant protein subunits, and nucleic acids are being researched and developed,…

May 7, 2020

Are You Missing the Bigger Picture with Your AAV Analytics? Fast, Low-Volume Subvisible Particle Analysis for Characterizing Viral Vectors

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Subvisible particle (SVP) analysis is a key indicator of stability and safety and is an essential parenteral drug quality metric. Yet assessment of SVPs is especially challenging in adenoassociated virus (AAV) vector formulations, in which limited precious sample is available. Traditional SVP methods consume large sample volumes, while dynamic light scattering (DLS), size-exclusion chromatography (SEC), and visual inspection can miss aggregates in the subvisible range entirely. This special report introduces backgrounded membrane imaging (BMI) technology as a solution for detection…

May 4, 2020

World-Class AAV Vector Suspension Platform to Accelerate Commercialization to Market with Greater Predictability

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This webcast features: Juan Lagos and Steve Tottey, Associate Directors of Upstream and Downstream Process Development, WuXi Advanced Therapies Developing innovative advanced therapies is one of our greatest opportunities to dramatically improve patients’ lives. WuXi Advanced Therapies launched a new world-class adenoassociated virus (AAV) vector suspension platform that complements integrated capabilities enabling cell and gene therapies to be developed, manufactured, and released faster and with greater predictability globally. In this webinar, we will discuss our recent technical advancement on efficient…

April 30, 2020

Bioprocessing 4.0 Accelerates Biological Research and Development Using Computer-Aided Biology

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Computer-aided biology describes a growing ecosystem of tools that augment human capabilities in the laboratory. In this report we give two case study examples of how computer-aided biology has transformed industrial gene therapy bioprocessing. Read on to discover how Synthace’s Antha cloud-based software platform has enabled industrial collaborators Oxford Biomedica and the Cell and Gene Therapy Catapult to harness the power of Bioprocessing 4.0 by: incorporating new process analytical technologies (PAT), such as Raman Spectroscopy, into their unit operations automating…

April 29, 2020

Challenges Of Host Cell Protein Analysis With ELISA And How To Obtain Better Coverage Of Your ELISA Antibody Reagents

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Why is host cell protein (HCP) detection and removal so critical when manufacturing biologics? Product purity and, most importantly, patient safety depends on it. Sandwich ELISA has been a favored method for HCP testing due to its high sensitivity and high throughput, but challenges and limitations exist. Coverage depends strongly on the use of antibody reagents that adequately detect and capture HCPs. In this webinar, we address effective techniques for both optimizing HCP ELISA coverage through the selection of reagents…

April 23, 2020

Identification of Host Cell Protein (HCP) Impurities using Antibody Affinity Extraction and Mass Spectrometry Approach

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This webcast features: Eric Bishop, Vice President of Research & Development, Cygnus Technologies A well-developed, broadly reactive, and qualified HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Unfortunately, the ELISA does not inform which HCPs are present or to which HCPs the assay reacts. Mass Spectrometry (MS) is a powerful tool for identifying those HCPs that persist through downstream purification…

April 23, 2020

Assembly, Labeling, and Packaging Trends: Next Decade’s Sterile Finished Goods Solutions

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This webcast features: Thomas Gabriel, Director, Strategy and Business Development, FUJIFILM Diosynth Biotechnologies Learn new trends in packaging, labeling, and distribution of finished goods and supporting technology platforms. At this event, there will be a presentation and dialogue regarding: patient convenience: trends, approaches and demands for future treatments medical device delivery systems of the next decade digitalization’s improvements to patient quality of life and medicinal ease of use manufacturing and supply chain networks of the future. Watch the recorded webcast…

April 20, 2020

Building Orthogonality into Biosimilar Testing

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Both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have developed regulatory guidelines on biosimilars (1, 2). These comprehensive documents provide clear guidance on what the agencies expect from structural characterization studies. Using state-of- the-art instrumentation and techniques is expected, but the use of orthogonal techniques in structural comparability assessments is also required. The application of orthogonal analytical techniques will provide a firm structural foundation to claims of biosimilarity. Characterization methods verifying and supporting conclusions drawn…

April 13, 2020

Brazilian JBS Federally Inspected Fetal Bovine Serum

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Serum is the most commonly used supplement in cell culture. Fetal bovine serum (FBS) is the common choice because it contains high concentrations of growth factors and other important signaling molecules (e.g., adhesion proteins, nutrients, carrier proteins, cytokines, and hormones) required for cell survival and differentiation together with its buffering capabilities. FBS production begins with the collection of whole blood from bovine fetuses under aseptic conditions. Once collected, the blood is allowed to clot, and the serum is mechanically separated.…

April 13, 2020