Tag: <span>single-use equipment</span>

From the Editor-in-Chief: Major Successes in the Industry and Primary Challenges That Follow

As biologics continue to advance at a dizzying pace, I want to take this opportunity to outline what I see as the major successes, as well as the primary challenges facing the industry. First, the science of antibody production appears to be quite settled. Significant value can be gained by finding ways to limit production batches to volumes that can be accommodated by single-use bioreactor systems…

Read MoreFrom the Editor-in-Chief: Major Successes in the Industry and Primary Challenges That Follow

Biologics Production

biologics bioproduction cellular therapies continuous downstream processing cryopreservation challenges downstream purification monoclonal antibodies personalized medicine real-time data scale-out scale-up single-use equipment viral gene vectors

Standards-Setting for Single-Use Equipment in Biopharmaceutical Manufacturing: An Update on Progress, and the Impact of Standards Implementation

Only a year ago, the lack of standards for single-use equipment systems (SUS), as covered in this journal, was cited as inhibiting growth in the bioprocessing industry. The need to establish more standardized approaches for single-use devices’ design, quality, and leachables/extractables that regulators and industry end-users could accept was slowing the acceptance rate of these novel devices…

Read MoreStandards-Setting for Single-Use Equipment in Biopharmaceutical Manufacturing: An Update on Progress, and the Impact of Standards Implementation

Biologics Production

bioprocessing industry extractables leachables single-use equipment sus sus standards