05.29.24 -- Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?

Uncover guiding principles to ensure that your CGT supply chain is future-proof and learn how an agile, flexible approach can help advance your project with reduced costs and delays.

Advanced therapies present challenges when it comes to scaling up production. Explore how collaboration, investment in R&D, and process optimization are paving the way for new treatments.

If you’re hoping to improve your QC toolkit to better accommodate complex modalities like CGTs, it's time to build a program that accounts for risk and unique product characteristics.

In Part 2 of our series, we delve deeper into the crucial elements of transparency that prospective clients should consider when partnering with a CDMO, including analytics, documentation, and more.

Yuki Shinohara from Ajinomoto Bio-Pharma Services answers attendee questions from a recent webinar about sustainability concerns surrounding oligonucleotide manufacturing.

Here, we evaluated the performance of two dbDNA IVT templates, each encoding the same mRNA (firefly luciferase or Fluc), by looking at the mRNA purity and in vivo potency of the mRNA IVT’d.

Examine how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges our clients face.

CDMOs play a critical role in the global effort to prepare for future pandemics. Unearth how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.

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.

Partnering with an experienced team dedicated to reducing contamination risk and capable of growing with you as your project advances through clinical trial stages is essential.

RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.