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January-February 2024 Featured Report: Ensuring Quality
Ensuring Quality

From Analysis to Environmental Controls

Aton ADC Development and Manufacturing Special Report
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ADC Development and Manufacturing

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Special Reports

Unveiling the Future of Bioprocessing: Cell and Gene Therapy Purification Strategies
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Discover the cutting-edge advancements in bioprocess intensification and cell & gene therapy purification with this comprehensive custom report from Astrea Bioseparations. Explore the latest innovations and breakthroughs that promise to revolutionize the field. HCPure™ Host Cell Protein Clearance Resin: Bioprocess Intensification through Mixed-Mode Chromatography Delve into the world of mixed-mode chromatography and how HCPure™ Host Cell Protein Clearance Resin is transforming bioprocess intensification. Learn how this technology is enhancing purification efficiency and streamlining biomanufacturing. Enhanced Efficiency in Cell & Gene Therapy: The Role of Plasmid DNA Purification Uncover the critical role of plasmid DNA purification in improving the efficiency of cell and gene therapy production. Explore the latest techniques and strategies that enable more efficient and reliable purification processes. Scalable Downstream Purification with Lenti HERO®: Safeguarding Lentiviral Vector Yield Expressed by A...

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The past decades have brought a tremendous increase in new biologics and biotherapeutics that offer patients more efficient and safer treatment options than they had before. Such revolutionary innovations in biopharmaceuticals are to a large extent thanks to advancements in upstream research and development, which are important drivers of bioprocesses. But despite this unceasing progress, upstream bioprocess engineers continue to face challenges and pain points in their work. In this article, Magnus Wetterhall, Global Marketing Manager — Bioprocess at Waters Corporation, highlights some of those pain points with a view to how comprehensive process analytical technologies (PATs) based on liquid chromatography (LC) and mass spectrometry (MS) can help to address such issues in development and manufacturing of new biotherapeutics. Fill out the form below to read the full report now.

Ask the Expert Webcasts

Boehringer Ingelheim BioXcellence™
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This webcast features:  Athelney Woolnough,  Director Business Development/Key Account Management BioXcellence,  Franz Schuster,  Strategy Implementation Manager Biopharma Austria,  Nikolaus Hammerschmidt, PhD, Head of Unit Downstream Development , Process Science, RCV, Boehringer Ingelheim. Boehringer Ingelheim BioXcellence™ offers comprehensive support for successful development and manufacturing, treating customers’ products as if they were their own. Their expertise spans both mammalian cell culture and microbial fermentation technologies. The microbial product landscape, a specialty market, demands a variety of manufacturing process formats to cater to different molecule formats. Their unique strength lies in the combination of their extensive commercial expertise and development capabilities. This enables them to provide the complete value chain, from early stages to launch and commercial supplies, for microbial derived biopharmaceuticals. Discover how they can help drive your biologic breakthroughs...

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The number of clinical trials investigating viral vectors and MSC-EVs as therapeutic and skincare agents has been increasing greatly over the years. The complexity and fragility of the vector-based products, scalability, yield, and purity of production processes are challenges to meeting demand. With this comes the requirement to ensure that there are robust manufacturing processes in place to scale with demand and to make these therapies readily accessible to those who need them. However, current manufacturing processes for vectors and exosomes have often been developed with limited scalability in mind and large shifts in technology must take place to enable industrialization. To overcome this challenge, we are presenting industrialization of an MSC-EVs case study which illustrates the next generation manufacturing process for large volume upstream manufacturing using high-quality hMSCs along with paired bioprocess medium formulations for cell growth and EV production and downstream clarification using t...