Search results for " filtration"
Article
Going Small to Achieve Success on the Commercial Scale
Scale-down models are used in the development of nearly every unit operation in the overall biopharmaceutical manufacturing process, including both upstream and downstream steps, and separation and fi…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The system consists of two bench-top chromatography instruments connected to a central unit with eight disposable filtration devices used for loading and filtering the cell cultures. The staggered par…
Article
Aseptic Processing: Keeping it Safe
Historical successes with “similar formulations, filtration dynamics, membrane types, and process parameters,” could help a sponsor satisfy FDA Phase I GMP Guidance requirements, but may not satisfy E…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
He adds that better-designed model bioreactor, chromatography, and filtration systems are allowing for even smoother scale-up and tech-transfer operations.
Raw material choices are also being adju…
Poster
Optimization of concentration and diafiltration of a bovine γ-globulin solution
This application note describes the development of a cross flow filtration process for concentration of a bovine
γ-globulin solution.
Article
Technologies and Practices Must Evolve to Meet Demand
Chromatography systems, filtration, and centrifuges received marks of “excellent” from more than 20% of the respondents (Table I). Sampling systems, single-use systems, and sterile sampling received “…
Article
Concentration and Diafiltration of Cell-Derived, Live Influenza Virus Using 750 C Hollow Fiber Filter Cartridge
In contrast to normal flow (dead-end) filtration (NFF), the feed is recirculated over a permeable membrane surface (cross flow).This application note describes the performance of GE HealthcareLife Sci…
Article
Evolution of the Monoclonal Antibody Purification Platform
• Virus filtration step is the method of choice as another orthogonal step for virus removal.
Major Adaptations to the mAb Platform
Use of multiple washes in Protei…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Before the sterile filtration step, the viral particles were concentrated and transferred into the final buffer by diafiltration using a ReadyToProcess hollow fiber cartridge (RTPUFP-500-C-9S). Finall…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Studies are ongoing on sterilizing filtration, effects of terminal sterilization energies on classes of products, and methods for detection of elusive microorganisms in drug components and manufacturi…