Novel fields, such as cell and gene therapy require large amounts of cells to be produced and are therefore dependent on efficient scale‐up, the process of increasing bioprocess dimensions. However, as multiple parameters are influenced during this process, it is not easy to keep yields consistent between small‐ and large‐scale approaches. Therefore, in order to design the scale‐up process as efficient as possible, different strategies focusing on different parameters were established over time. In this ebook, Eppendorf thought leaders will give an overview of the current gold standards in scale‐up and share their opinions on advantages and disadvantages of different strategies. Furthermore, scale‐up of both bacterial and mammalian cell culture is experimentally demonstrated in this publication.
Novo Nordisk reports positive phase 3 CagriSema data, Biocon’s pertuzumab biosimilar gets a positive CHMP opinion under EMA’s new tailored pathway, and Vironexis reports complete responses with its one-time in vivo therapy for relapsed ALL.
Eron Kelly, CEO of ConcertAI, and Dr. Shaalan Beg, CMO, oncology, ConcertAI, discuss how AI can help physicians access the right information at the right time while supporting clinical trials, research, and quality initiatives.
Biocon's Pebrilzo, a pertuzumab biosimilar for HER2-positive breast cancer, has become the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's newly adopted tailored clinical approach, which can reduce comparative efficacy trial requirements.
Vironexis Biotherapeutics reported that the first three antibody-naive patients with relapsed/refractory acute lymphoblastic leukemia treated with its one-time in vivo immunotherapy VNX-101 all achieved MRD-negative complete responses, with durability tracked through at least nine months.