09.20.23 -- Takeda's Green Approach To IG Purification And Filling

Learn about strategies to meet the quality and regulatory requirements of cell and gene therapies and how to identify issues early on, reduce quality and compliance risks, and avoid delays and rework.

The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive. Enter the "factory-in-a-box," which can be a game changer.

Review a global approach to bioinformatics supported by four pillars: derivation of sequence-based features, building structural 3D models, exploring molecular flexibility, and analysis of the complex multi-dimensional data.

The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end user.

Pressures surrounding the supply chain, cost, and foundational science that accompany cell therapy development have created new uncertainty and hampered investment.

To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

It is important to pursue a dualistic, longer term supply strategy that embraces cost control and supply reliability/diversity to improve the integrity and resilience of international supply chains.

Learn about the potential of silkworm larvae plasma (SLP) including bacteria detection and identification and peptidoglycan detection.

Evaluate the performance of an E. coli kit based on its detection sensitivity, quantification accuracy, and replicate uniformity as it performed when tested on a digital PCR system.

Learn about host cell proteins (HCPs), along with how they are produced, their negative effects, how to identify HCPs in drug substances, and some technologies offering solutions for manufacturers.

Technology has evolved to make high-containment systems financially reasonable. Explore how single-use containment technology impacts capital spending and operating expenses.

Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

Finding a manufacturing partner with the capabilities and capacity to offer truly end-to-end development and scale-up can mean the difference between successful commercialization and the end of the road.

Explore automating feeding based on the DO spike through the course of the bioprocess run and the benefits over manual processes.

Learn how a CDMO partner with deep technical and regulatory expertise and flexible support options is critical to advance your molecule toward commercialization with speed and reduced costs.

Learn the elements and market factors impacting the make/build vs. buy decision, considerations to examine when evaluating options, and best practices for navigating this decision.

The pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding, and strategies to improve the performance of IB processes.

If you are seeking protein size separation information in addition to immunodetection of protein target(s) of interest, these assays can provide more sensitive, accurate, and reproducible readouts than ELISA.

Learn how Lakes Bioscience and the National Horizon Centre are harnessing virtual reality for education and training and to get medicine to patients faster.

Explore critical considerations for optimizing cryopreservation that will help you to deliver program goals faster and ensure cell therapies are translated into consistent, potent, and accessible medicines.