Intensified processing represents a major trend in the biopharma industry because it increases the productivity of Single-Use (SU) facilities, while decreasing the manufacturing footprint. Here's how to optimize the approach.
As global patient populations increase, there are a growing number of challenges and demands faced by pharma and biotech companies to ensure product is delivered in a timely and cost effective way. An alternative solution to the 'build or buy' decision is the use of readily available, pre-qualified GMP facilities which can be fully tailored to suit individual needs and provide reassurance that product will be delivered on time and on budget.
Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial manufacturing, understanding the operational, regulatory and quality connections is critical for successful filing and launch. This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step.
The generation of foam is common in aerobic bioreactor systems. This application note outlines the cause of foam, use of antifoaming agents to control foam, design and integration of the single-use foam probe (including a mounting system and bioreactor controller integration), and several successful case studies utilizing the foam probe in aggressive bioreactor cultures. This study demonstrates that foam can be controlled across all S.U.B. sizes, 50 to 2,000 L.
Successful and rapid analytical method development plays a key role in ensuring the development of robust processes to produce high-quality products. When standard or predefined methods fail because of buffer components or because proteins do not behave as expected, solutions can be found when the team has the knowledge and flexibility to explore the use of alternate methods.
Due to the legalization of cannabis and the associated legislation concerning trace metal analysis the demand for fast and easy-to-use acid digestion techniques is increasing. HVT vessels with SMART VENT Technology enable the convenient and reliable digestion of cannabis-based products prior to spectroscopic analysis.
Processing powder blends can present a number of challenges: component powders may be poorly flowing in the process, the blends may be susceptible to segregation, or the formation of agglomerates may affect homogeneity. It is essential to identify powder properties that can be applied to characterize dry granulates in a relevant way, and to optimize dry granulation processes. This application note details investigates how process parameters influenced the properties of the dry granulate of a placebo formulation.
Adjuvants such as aluminum salt (Alum) are commonly added to vaccines to enhance their immune responses. A resulting sediment can be more or less compact and difficult to redisperse depending on the strength of the bonds between particles. In this note, we propose a rapid evaluation method (less than 30 minutes) of the sediment redispersibility.
Across the powder handling industries screw feeders are used to control the flow of material from a dispenser or hopper into a process. The properties of the powder have a direct impact on the performance of the feeder making it essential to tailor the design and operating conditions of any given system to the specific powder being handled. A poorly matched powder/feeder combination will typically be associated with low feed rates, high screw torques and the accumulation of powder on the auger walls. All these factors decrease both short and long term operating efficiency.
See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.
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