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Fine-tuning Transient Transfection Conditions is a Prerequisite for Optimal Upstream AAV Manufacturing

Setting up robust and reproducible bioprocesses is a top priority for all biotechnology companies focused on developing life changing AAV-based gene therapies. To do so, innovators crave for breakthrough technologies to maximize productivity while controlling the cost of goods (CoGs) of their AAV vector manufacturing workflow, key to accelerate the speed to commercialization of their clinical programs pipeline. Helper-free triple plasmid transfection of HEK293 cells – adherent or suspension – is the most used upstream method for AAV manufacture. Observing…

Enabling mRNA-Based Therapeutics Development Through Efficient and Scalable mRNA Purification Methods

This webcast features: Jenny England, PhD, R&D Manager, Innovation & Applications Group, Thermo Fisher Scientific. As a direct result of the COVID-19 pandemic, mRNA-based therapeutics development has made major progress. The potential of using mRNA as a therapy seems to be endless and an increasing number of indications is filling up the clinical pipeline rapidly. As the development of these therapies continues to rise, the industry is looking into efficient and scalable manufacturing techniques. To support the commercial production of…

Integrating PendoTECH Single Use Sensors for Industry 4.0

Industry 4.0 refers to the ongoing Fourth Industrial Revolution, which is currently transforming modern manufacturing and production practices through the use of smart technology and artificial intelligence. At a high level, Industry 4.0 has paved the way for the integration of manufacturing execution systems (MES) with enterprise resource plan (ERP) systems and supervisory control and data acquisition (SCADA) systems. Biopharmaceutical manufacturing is currently evolving with the progression of Industry 4.0. The integration of business and manufacturing systems in an intelligent,…

Bioprocess Considerations for Large Scale Transfection

This webcast features: Geddy Hamblen, Field Applications Scientist, Mirus Bio. As demand for viral vectors has grown in recent years, larger production scales are increasingly common. As processes scale, transient transfection must also scale to match. The VirusGEN® family of transfection products, developed by Mirus Bio, has been used successfully at scale in clinical manufacturing and brings unique advantages leading to higher titers and a more robust manufacturing process. In this webinar we will discuss: Challenges and solutions for transfection…

Novel Dual-Plasmid Transfection System Improves Titer And Product Quality In AAV Manufacturing

Adeno-associated virus (AAV) vectors are a widely-used, versatile, and appealing gene therapy delivery platform because of their high safety profile and ability to target many different cell types and transport healthy gene copies into a patient’s cells. The recent clinical successes of AAV-mediated gene therapies have ignited much interest in solutions for the scalable, good manufacturing practice (GMP) production of AAVs, and high demand for outsourced development and manufacturing capabilities. Yet, significant challenges remain, particularly around product quality, productivity, and…

High-Selectivity HPLC mRNA Analytics: Quantification and Characterization

Robust and precise chromatographic analytical methods are key for the efficient development of the mRNA production process. Three different analytical methods, which utilize three different column chemistries, are embedded in a ready-to-use PATfix™ HPLC analytical platform to support mRNA process development and product quantification and characterization. Fill out the form below to download the full report from BIA Separations, now a Sartorius Company.  

Guidelines for Developing a High Cell Density Cryopreservation Process

Biopharmaceutical manufacturers are leveraging several approaches to intensify processes with a goal of improving efficiency and productivity and reducing costs — all while ensuring the highest quality standards. The upstream workflow offers several opportunities to apply next generation technologies and methods to achieve these important goals. In this white paper we discuss integration of high cell density cryopreservation (HCDC) in the seed train and explore key considerations for developing a cryopreservation process including choice of cryoprotectant and freezing techniques. Use…

Screen Smarter Not Harder: Expand and Accelerate Your Cell Line & Viral Vector Screening

This webcast features: Andres Castillo, Portfolio Manager, Sartorius & Shanya Jiang, PhD, Portfolio Manager, Sartorius. Viral-based therapies like gene therapy or vaccine development require broad and thorough process screening before transitioning into optimization. Screening sets the stage to choose the best performing media, key parameters, and cell lines with minimal variability before optimizing the critical process parameters (CPPs) and critical quality attributes (CQAs). In this 15 minute webcast, Andres Castillo and Shanya Jiang, PhD from Sartorius present an automated and…

Enabling Capabilities and Solutions for all mRNA (Nucleic Acid) platforms – Process Development, Manufacturing and Formulation

Conquer the mRNA era. Advancing together from initial idea to final product. Your molecule’s journey to the market is a long and complex one. You need an experienced and trustworthy partner who understands the varying challenges you face and helps you solve them efficiently, safely and speedily. No matter whether you’re still in the idea stage, ready to scale up your production or need specific regulatory know-how for a successful launch of your mRNA drug. From mRNA development and manufacturing…

The Unique Properties of Gelatin in 3D Bioprinting

How to select the right bioink to secure proper cellular characteristics and functionalities in engineered tissues: exploring the benefits of low endotoxin gelatins. Gelatin has long been a trusted excipient in the pharmaceutical industry. For advanced biomedical applications like in-body use, there are strict regulations for endotoxins levels of the final product (medical device) to avoid unwanted side-effects. 3D bioprinting is a very popular tissue engineering technology used in the field of regenerative medicine. In this whitepaper, we explore the…