02.02.23 -- The Pros Of Outcomes-Based Agreements

Explore the key considerations for designing successful gene therapy trials in the available blog.

A cleanroom facility that remains safe for your workers – and ensures the therapeutics they produce remain safe for patients - can ease your compliance concerns.

It is critical to vet not just the expertise available at a CDMO but also the effectiveness of their facility design to reduce risk and meet scale-up needs.

The gene therapy clinical pipeline is in a high-growth phase, with an influx of venture capital funding. There are also challenges: scalability, dosing, and the price of the final treatment.

Finding a CDMO that can perform all the necessary testing for an AAV product can make a significant difference for a nascent company or novel drug.

Read how the sources of inefficiency are reduced and so are the hazards when construction components are manufactured off-site and delivered on time.

Learn how osmolality testing provides quick and easy identification of where certain solutions may be deviating from specification in the biomanufacturing sector of the clinical market.

AAV tissue biodistribution and cell tropism are essential pieces of information for every gene therapy development program. The RNAscope ISH assay is a highly informative method for quantitative, cell-specific measurement of AAV vector and transgene expression.

Evaluate cell products on a single-cell basis to identify and understand the direct relationships between the cell’s cytokine profile and its effector function subsets.

Plug and play platforms can be adapted to different therapeutic genes without starting the development from scratch for each product, making the transfer to GMP as fast and smooth as possible.

A good manufacturing road map provides flexible guidelines to advance automation. It’s a living document and will be refined many times as manufacturing needs and processes evolve. The key is mapping out the entire process and developing a clear understanding of what needs to be done and when. Here are the key questions to ask when building a manufacturing road map.

With roughly 90% of all drugs failing to make it through clinical trials, accelerating the first step of getting to the clinic with a new mAb candidate is crucial.

Learn how professional training and education programs combined with advanced digital learning technology are key to train local talent and secure biomanufacturing resilience.

Learn about the clinical trial for a new sickle cell disease treatment from an early clinical trial patient who has, at this time, experienced complete recovery from symptoms.