09.14.23 -- Patent Claims Involving AI After Amgen v. Sanofi

We detail the approach we’ve taken to not only speed up the processing of macromolecule electrospray MS data but to build smarter deconvolution workflows.

Explore how recent CGT breakthroughs hold the potential to create meaningful change for patients living with genetic diseases and the obstacles developers are navigating on the path to commercialization.

Discover tips on operationalizing gene therapy studies in order to optimize site selection and patient recruitment and engagement.

To address cost, timelines, and manufacturing complexity, many developers utilize turnkey platforms. Can these platforms provide the right solution for successful CMC development?

Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

Compare and contrast the different methods available for designing and constructing a cleanroom, including stick-built construction, modular panels, prefabricated modules, and mobile cleanrooms.

Leveraging the right LVV manufacturing platform can accelerate timelines, manage costs, and transform product development and potential for clinical success so that therapies reach patients in need.

As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.

This executive summary covers a closer look at cell and gene therapy pipelines, choosing a viral vector, including adeno-associated virus, gamma retrovirus, or lentivirus, and current lentiviral trends.

Review the results gathered from a driver and software system when used to perform data processing on RNA samples separated by capillary electrophoresis (CE).

Research is being done to study a new method for isolating TILs from human colon tumor xenografts that could be more efficient and effective than traditional methods.

Are you seeking guidance to evaluate cleanroom design/built parameters? Learning the total cost of ownership (TCO) and cost-benefit basics is a good place to start.

Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and insights from scientists and R&D. Discover how manufacturers can combat these costs.

Since the first rAAV-based therapy was approved by the FDA, application of gene therapies utilizing rAAV vectors has exploded and active clinical programs are being fast-tracked for clinical approval.

Review a T cell manufacturing platform's ability to reduce manufacturing variability by elutriating lymphocytes from apheresis, providing a more consistent cell product for downstream manufacturing.

Explore a study demonstrating the use of dielectric spectroscopy tools for monitoring expansion and differentiation of hiPSC aggregates in stirred-tank bioreactors.

Explore key considerations for process development, analytical methods, and manufacturing factors to help advance viral vector gene therapies, as well as factors that can help improve CMC outcomes.

Explore how a stepwise approach for process characterization can help target the right experimental design and be tailored for different programs based on prior knowledge and experience.