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Event Partner
Pall Biotech is the leading global provider of filtration, purification and separation products and technologies to the diverse and rapidly expanding biopharmaceuticals market. These products and technologies are used from the earliest stages of discovery and development of new drugs, through production and delivery of therapies for the prevention, diagnosis and treatment of disease. Our biopharmaceutical products are supported by extensive protocols and technical reports, an industry-leading scientific and technical staff, and worldwide offices and distributors for easy ordering.
Pall's unique capability comes from a strong blend of biopharmaceutical expertise, customer support and leading technologies. We provide reliable and fully integrated solutions for the design, manufacturing, sales and service of our products. We offer comprehensive technologies and support for a wide range of biopharmaceutical markets and applications throughout the world, including active pharmaceutical ingredients, biotechnology, formulation and filling, pharmaceutical quality control, plasma fractionation, vaccines, chromatography, sterile filtration, mycoplasma control, and many more.
Stand number
1523
Updates on Integrated End-to-end Continuous Bioprocessing, and a Brief Regulatory Perspective
Integrated end-to-end continuous bioprocessing is becoming a reality. Enabling technologies recently developed by technology providers have been implemented in the industry at PD and clinical manufacturing scales. The data published in many articles and presented at conferences during the past few years validate the anticipated benefits of continuous bioprocessing. This presentation will update on the technology developments further enabling continuous bioprocessing and give a regulatory perspective to complement this implementation
The Cell Harvesting Guide: Evaluating the right harvesting technology from a cost/performance perspective
Allegro™ STR Single-use Bioreactors
Several key design parameters were characterized for different sized single-use bioreactors within Pall Allegro™ family of single-use bioreactors. Maintaining equivalent power per unit volume as the primary scaling parameter, data from CHO cells cultured in these bioreactors demonstrate cell culture scalability across the entire Allegro™ Single-use bioreactor platform.
Virus Safety for Continuous Processing
Continuous bioprocessing is increasingly seen as a means to decrease the cost and increase the quality of biotherapeutics. However, moving to a continuous process raises regulatory concerns. Here we address virus safety for continuous processing holistically, providing performance data and potential validation strategies for virus safety via continuous chromatography, low pH inactivation and virus filtration.
A Rapid Process Development Strategy for Continuous Chromatography mAb Bioprocessing
This study demonstrates a strategy for direct implementation of optimized process parameters in streamlined three-step continuous chromatography processes. A design of experiment approach with single column investigations (batch mode) is used to simulate a multi-column (continuous mode) purification method. By utilizing this strategy, two robust and predictable continuous monoclonal antibody (mAb) bioprocesses were developed within seven weeks.
Assuring sterility of genderless sterile connectors from manufacturing to point of use - a Quality by Design (QbD) approach
A key requirement for multi-component single-use systems is the need to make safe and secure connections between the various manifolds using a sterile connector. This presentation describes the approach to the design, development and validation of the Pall Kleenpak® Presto sterile connector, with a unique manufacturing procedure that ensures the robustness and full traceability of every genderless connector produced.
Standardization of single-use systems: a case study for an end-to-end process solution
The customizability of single-use systems can be a double-edged sword. Being able to “have it your way” is appealing, but higher costs, longer lead times and inventory management challenges are common concerns with custom designs. In this session, we present a case study illustrating how a more standardized approach can offer significant cost and time savings without compromising process performance.
Application of Prior Knowledge Assessments to Facilitate End User Virus Filter Validation
Virus filtration is a critical component of the virus clearance strategy for biopharmaceutical applications. We verify our virus filter design space studies can be used to facilitate prior knowledge assessments, by comparison to end user filterability and virus validation data across ranges of fluid properties and process parameters, such as pH, operating pressure and process interruptions.
