Take a few minutes and navigate through our mAb, ADC, mRNA, Vaccine, and Cell and Gene Therapy process templates. Go ahead and dive into each unit operation to uncover the best option for your process.
• Viral vectors are the most reliable and sought-after method for gene delivery.
• Use of adherent cell culture for manufacturing these vectors, however, can lead to limited cell growth, lower productivity, and necessitate use of animal-derived media supplements which increase the risk of introducing adventitious agents.
• The VirusExpress® 293 AAV production platform reduces risk and accelerates timelines with use of chemically defined animal component-free cell culture media that has been optimized for viral vector manufacturing.
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This whitepaper provides an overview of the technology transfer process and describes the development and optimization of a platform to manufacture a vaccine for tropical diseases.
21 CFR Part 11 and Annex 11’s purpose is to ensure electronic records and signatures are equivalent to paper-based records and handwritten signatures. Beyond proving equivalency, software used for electronic records and signatures offer benefits like access control, audit trails, data integrity, and easy search and retrieval of information.
• Cell and gene therapies have delivered remarkable outcomes for patients with a wide variety of diseases and conditions.
• These therapies rely on adeno-associated viral (AAV) vectors and lentiviral vectors and are essential for delivery of genetic material into target cells.
• Use of adherent cell cultures for vector production are limited in terms of scalability and have historically relied on media formations that were not optimized and supplemented with fetal bovine serum.
• In contrast, suspension culture systems deliver significant benefits for upstream viral vector production processes including higher AAV and lentivirus vector titers and robust scalability.
This collection of insights, produced through a partnership between
This post discusses the environmental challenges posed by the Biopharmaceutical industry’s heavy reliance on single-use systems and the resulting plastic waste. It highlights the industry’s quest for sustainable solutions through advanced recycling methods to achieve circularity.
In this webinar, join industry experts to learn about strategies to accelerate mRNA therapies and enable scalability and process efficiency from preclinical to commercial.
Purification efficiency evaluated endotoxin and host cell protein (HCP) clearance, plasmid yield, potential interference of the detergents with analytical in-process control assays, and overall process compatibility, and this comprehensive screening approach provides valuable insights to intensified plasmids production.
