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.
FDA has reportedly shelved its Commissioner’s National Priority Voucher pilot and paused publishing complete response letters, Zai Lab’s IL-13/IL-31Rα bispecific ZL-1503 shows a 40- to 50-day half-life that points to dosing every 12 weeks, and Wave Life Sciences reports 1-year INLIGHT data for its INHBE-silencing siRNA WVE-007 in obesity.
FDA has effectively paused its Commissioner’s National Priority Voucher pilot and appears to have halted new complete response letter postings, according to reports. HHS says work on the program is ongoing.
A single dose of Zai Lab’s long-acting bispecific ZL-1503 produced at least 90% inhibition of an atopic dermatitis signaling biomarker through Week 12 in healthy volunteers. Its 40- to 50-day half-life supports a target of dosing every 12 weeks.
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
