The Dish’s Biotechnology News Wrap Up – December 9, 2022
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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
New Technology Solutions for Lentiviral Vector Clarification
The growth of the cell and gene therapy sector, and the growing number of gene and gene-modified cell therapies entering the market has translated into an increased global demand for lentiviral vectors (LVs) as a gene delivery tool. There are currently two FDA approved LV-based cell and gene therapy products—Kymriah® (Novartis) and ZYNTHEGLO® (bluebird bio), and according to the Alliance for Regenerative Medicine, an estimated 48% of the ongoing cell and gene therapy clinical trials use lentiviral vectors, with a significant number in late-stage evaluation1. The strong pipeline of LV-mediated gene and CAR-T cell therapy products headed towards market approval means the development of efficient LV vector purification methods to improve yield and recovery is needed to meet the growing demand while also driving down the cost of production2,3. The critical first step in the downstream process is clarification of the viral bulk, which aims at removal of cell and cell debris and to reduce turbidity of the solution. Since each process step potentially reduces the quantity of infectious LVs, effective clarification helps minimize LV vector loss from the outset of the downstream process to maximize final product recovery4. In this publication, we will examine counterflow centrifugation (CFC) as a scalable technology solution to achieve high throughput and high yield clarification of infectious LVs…Biomanufacturing Quality Management Systems – A holistic approach
In this podcast, we interviewed Katie Keller, Director of Quality and Safety at Asahi Kasei Bioprocess America, about the importance of quality management and how to achieve the best possible results. Topics included the most critical elements of quality management, how to ensure the purchase of high-quality equipment, and future trends…
Flexible single-use mixers are key to achieving a next level mixing experience and reducing delivery lead times
In this podcast we spoke with Klaus Kienle, Global Product Manager for the Mixing portfolio at Pall Corporation about the latest mixing technologies including single-use solutions, the need for increased flexibility, and a more standard vendor agnostic approach…Bioprocessing Solutions to Accelerate Mammalian Cell-Based Vaccine Development
Vaccination remains one of the most effective methods to combat infectious viral diseases such as influenza. The recent COVID-19 crisis has placed unprecedented pressure on the vaccine industry to develop and deploy vaccines against emergent diseases faster than ever before. An eBook, Solutions for Vaccine Development, released by Eppendorf has been created to provide the reader with an in-depth understanding of how the COVID-19 pandemic has irreversibly altered the landscape of global vaccine development. The content includes application notes, product guides, and expert insights to accelerate your vaccine research and development…Manufacturing high concentration mAbs challenges and solutions
In this podcast, we spoke to Tom Watson, Group Leader, Product Management – Biotech Division, Gregor Kalinowski, Manager SLS Purification Consultants Europe, and Aude Iwaniec, R&D Bioprocessing Team Leader, all from Pall Corporation, about why high concentration mAbs are an increasingly important part of the biotech landscape, current manufacturing challenges and solutions, and future trends…
Future Proofing Downstream Bioprocess Operations
Historically, downstream bioprocesses have been simpler than upstream bioprocesses. They were more manual and Protein A columns permitted a simple and effective purification solution for monoclonal antibodies and protein-based therapeutics. More recently, upstream bioprocesses have undergone significant improvements in process and subsequently yield. These improvements in upstream created bottlenecks in downstream as the systems in place were not prepared to adjust to changes in both the starting material from upstream and yield. As a result, downstream bioprocesses have had to evolve to meet the needs of these new challenges by incorporating technology advancements such as single-use technologies, improved chromatography solutions, continuous processing, advanced buffer management systems, increased automation, and many others…A Guide for Navigating the Single Use Technology Supply Chain
In this podcast, we spoke with Emanuel Krobath, Biopurification Specialist and Chiara Pacini, Bioprocess Specialist both with Pall Corporation about gene therapy process development including challenges and resources that are available for support…VEGA VEGAPOINT 21®– a non-contact probe for point level control in hygienic bubble traps
Gas bubbles in process fluids and buffer solutions are a common yet significant problem in bioprocessing because they can alter the microfluidic environment and negatively impact downstream chromatography steps. They can impede the flow through the resin column and limit contact with the resin in the resin bed, which can decrease separation efficiency and resolution. A hygienic bubble trap is a device that effectively separates gas bubbles from process fluids by allowing the bubbles to rise to the top of the fluid (Figure 1). Effective separation of gas bubbles relies on accurate monitoring and control of the fluid level in the bubble trap—this is where level sensors come in. The working volume of a bubble trap is typically 60-80% of its total volume, and the fluid should have a residence time of approximately 15 seconds. If the level is too low, the gas bubbles don’t have sufficient residence time to be effectively removed from the process fluid and the bubbles may pass with the process fluid through the bubble trap outlet. Conversely, if the level of the fluid is too high, fluid and bubbles can be drawn into the gas vent line and cause problems with contamination…Fit for Purpose AAV Purification – Realizing the Perfect Scale for Cell and Gene Therapies
The explosive advancements within the cell and gene therapy sector have the driven the demand for high-quality GMP-compliant viral vector manufacturing. Adeno-associated virus (AAV) has been the primary vector driving this growth, as well as to a lesser extend lentivirus (LV) and adenovirus (AV). The use of these vectors is expected to grow fast also in the future and to diversify to include other therapies, such as oncolytic viruses…White Paper:
Vaccination remains one of the most effective methods to combat infectious viral diseases such as influenza. The recent COVID-19 crisis has placed unprecedented pressure on the vaccine industry to develop and deploy vaccines against emergent diseases faster than ever before. An eBook, Solutions for Vaccine Development, released by Eppendorf has been created to provide the reader with an in-depth understanding of how the COVID-19 pandemic has irreversibly altered the landscape of global vaccine development. The content includes application notes, product guides, and expert insights to accelerate your vaccine research and development.
To Download the full ebook, see Solutions for Vaccine Development
Training Video:
Are you exporting animal by-products to the EU?
Confused, perplexed, or bemused with regards the rules and regulations? ISIA will be releasing a training video where their experts will guide you through the red tape, acronyms, and jargon. This seminar is designed to give the insights needed to successfully have products enter the EU. Please visit the link below to register.Please visit the link below to register.
The link to register for the training module is: https://www.accelevents.com/e/