Name:
In Focus: Raw materials
Description:
In Focus: Raw materials
Thumbnail URL:
https://cadmoremediastorage.blob.core.windows.net/0834d5af-9453-4959-828d-727a71033c44/videoscrubberimages/Scrubber_5.jpg
Duration:
T00H01M55S
Embed URL:
https://stream.cadmore.media/player/0834d5af-9453-4959-828d-727a71033c44
Content URL:
https://cadmoreoriginalmedia.blob.core.windows.net/0834d5af-9453-4959-828d-727a71033c44/RMN CellGenix V6.mp4?sv=2019-02-02&sr=c&sig=pVV%2BBAjslkL2tACpU8QfTmy%2BUY446Sp3EdQAl7WgUv0%3D&st=2024-05-12T14%3A57%3A30Z&se=2024-05-12T17%3A02%3A30Z&sp=r
Upload Date:
2023-08-11T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
SPEAKER: Hello and welcome to reg RegMedNet. This month, we're putting raw materials in focus. Quality, advanced therapy products start with quality raw materials, but how do you select the right raw materials for the right stages of your cell therapy development and manufacturing process? Raw material requirements change as you transition from preclinical research to clinical and commercial manufacturing. In the clinical and commercial phases, the safety of the raw materials is critical to ensure patient safety, and regulatory compliance is essential to gaining approval for your final cell therapy.
SPEAKER: Delay in delivery or raw material contaminations could lead to delays in production, not only increasing costs but also putting precious patient samples in jeopardy. It's therefore essential to have a secure supply chain in place and to use high-quality raw materials with reliable quality and high batch-to-batch consistency. In this feature, in association with [? Sartorius-Zogenix, ?] we'll discuss how you can make the transition from the preclinical development phase to the clinical and later commercial manufacturing phase as smooth as possible.
SPEAKER: We'll investigate the advantages of utilizing preclinical-grade instead of research-grade raw materials in your preclinical development. We'll also dive into why GMP raw materials are necessary for the clinical phase and how to decide when to make the switch. Experts from [? Sartorius-Zogenix ?] will explain how you can reliably test raw materials, such as cytokines, from different suppliers.
SPEAKER: They'll also give their tips on setting up reproducible and comparable assays and explain how to analyze the results to make the most out of your raw materials. Join the conversation today at RegMedNet.com or follow the discussion on Twitter, Facebook, and LinkedIn. We'll see you there.