Clarifying cell culture broth is the first downstream unit operation in an elaborate sequence of steps required to purify a biological therapeutic. A combination of centrifugation, depth filtration, or tangential-flow filtration (TFF) is used for that operation. The availability of large-scale, single-use, depth filtration technology in the recent years, however, has given process developers the capability to improve and simplify downstream processes.
Two case studies are presented highlighting the impact PLEX-ID System can have to rapidly identify virus contaminants resulting in better control of biologics manufacturing process, with the potential to characterize various sources of excursion through genotyping information.
This case study highlights a seven month project to upgrade a 100L stainless steel facility to a 2000L single-use facility without affecting current clinical manufacturing while adhering to cGMP requirements.
The mainstream adoption and success of mobile, single-use manufacturing platforms, combined with the introduction of off-site training programs provide companies with the ability to quickly set up and operate fully functioning biomanufacturing facilities globally.
This presentation outlines the key issues facing the R&D and Quality cGMP environments and presents key IT-based solutions that have been implemented by leading pharma and biotech companies.
Speakers: Karin Lucas Director, Training & Education BioTech Primer, Inc Timothy Fawcett Scientific Director BioTechnical Institute of Maryland, Inc. Listen to the audio cast here
In order to match the improved titers and yield Innovation has provided, many biopharmaceutical companies are re-evaluating the operational costs of stainless steel and exploring the economics of single-use systems.
While the Biosimilar market is expected to reach $20B by 2020, four factors will play a major influence on just how quickly the biosimilar market will grow: patent expirations, regulatory pathways, development challenges and viability of a commercial model.
As the adoption and maturation of single-use technologies continues to evolve, many end-users are looking for single-use suppliers to standardize products, materials, and equipment in order to improve efficiency and lower costs. An expert group of industry suppliers discusses the pros/cons and differing expectation surrounding this trend.
No single strain or vector is capable of being the best expression option for all types of biopharmaceuticals. The XS Systemâ„¢ ultimately decreases the time of strain screening and design to enable the fast creation of a valuable production strain and efficient cGMP process.