The BPOG Leachables Working Group has recently published a Best Practice guide for Leachables. It was developed to help biopharmaceutical and vaccines manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of single-use systems in manufacturing processes. The Best Practice guide is composed of three parts:
- the risk assessment model
- leachable study design
- analytical methods
This webinar provides insight into the application of the best practices for leachables study design by end users, and will include a case study to highlight the importance of the study design.
Single-use technology has established itself as an integral part of the biomanufacturing process - helping to preserve space, increase flexibility, and save money. Thoughtful design for the handling and transfer of sterile liquids is a key consideration when designing single-use systems, and advances in equipment such as sterile connectors have facilitated many of these operations. Assuring aseptic connections are reproducible and sterility is maintained during fluid transfer is underpinned by the design, materials of construction, and in-built quality of the connector. In addition, assessing the risk posed by leachables, which are potentially present in final drug product, is a regulatory requirement of biopharmaceutical manufacturers. Key to understanding the risk posed by leachables from single-use connectors is data based on agreed test methods, such as BPOG, that enables end users to make informed decisions on patient safety.
This webinar will explore Pall’s approach to incorporating user requirements in developing the Kleenpak® Presto sterile connector, the next generation genderless sterile connection technology for aseptic fluid handling and management in single-use biopharmaceutical manufacturing.
A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.
Following recent mainstream media coverage of reported supply and demand mismatch, viral vectors now dominate much of the discussion within the cell and gene therapy sector. This panel webinar will provide insight from three leading experts at the forefront of vector manufacturing, as they share first-hand experiences in moving to commercial-scale manufacture of viral vectors.
The Cadence™ Virus Inactivation (VI) system, a fully automated low pH virus inactivation system for both batch and continuous processing is one of the latest additions to Pall’s Continuous platform. This webinar will discuss how traditional low pH virus inactivation has been translated into an automatic system, and also the additional challenges associated with making it a continuous process. There will be a review of the two methods used for validating the design and an overview of the integration of capture chromatography and virus inactivation, which represents the first commercial scale combined unit operations in this space.
Learn the findings of the full-factorial modeling exercise
Understand the cost benefits of continuous bioprocessing at many scales of manufacturing.
- Learn how to implement Quality by Design (QbD) principles, and process validation strategies for continuous virus filtration
- See the process inputs that should be evaluated to determine critical process parameters
- Learn how a Pegasus™ Prime virus filter achieves high virus retention and delivers a robust and efficient continuous process
- Learn how to reduce facility footprint, capital expenses and product cost-of-goods
- See how you can improve your process productivity, flexibility, and further facilitate the utilization of single-use and/or disposable technologies
Continuous bioprocessing for biologics manufacturing is being adopted in the biopharmaceutical industry. Pall Life Sciences has brought several innovative technology platforms to the market to address the opportunities for Continuous Bioprocessing. In this webinar, Pall’s development journey in continuous bioprocessing will be introduced along with highlights of recent technology advances and product introductions for both PD and GMP operations.
We address optimal configuration of a multi-column continuous chromatography (MCC) system, with insight into the impact antibody titer has on the number of chromatography columns required to optimize productivity of a MCC process.
MCC has been gaining increasing interest as an enabling bioprocessing technique that allows for increases in specific productivity (g/L/hr) and operating binding capacity (g mAb/L sorbent) over traditional batch solutions. With recent advances, users have reported an increase in cost savings stemming from reduced resin volumes, lower buffer consumption, and increased resin usage.
Mark Pagkaliwangan presents, with David Johnson moderating, as they discuss MCC solution advances with processes utilizing two columns or more. They will explore how the total number of columns used in a process can affect performance, and how titer and flowrate can be optimized with more columns for greater efficiency and productivity.
- Results of experimental findings and insights from execution of both the BPOG and USP <665> extractables protocols on multiple single-use components including similarities and differences in extraction profiles
- Details of case studies illustrating how Pall’s growing portfolio of BPOG extractables datasets can be used to help support component qualification and overall toxicological risk assessment for single-use systems
Our team will examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and suggest practical, total solutions.
Many industries have adopted a one-piece flow approach (continuous manufacturing) to leverage the core reductions in inventory, increased operational flexibility, and greater product consistency and quality that it delivers. However, biopharmaceutical manufacturers have been slow to put continuous processing theory into practice due to the highly-regulated nature of the industry.
In this webinar, Peter Levison, PhD will moderate as Mani Krishnan, PhD and Marc Bisschops, PhD examine the evolution of interest in continuous bioprocessing, the advances being made in today’s market, and how the regulatory authorities are responding. Mani will also offer insight into the technological challenges of implementing continuous bioprocesses, and potential regulatory questions surrounding batch definition, bioburden control, virus clearance, scale-up/down, defect perturbation, design space, etc. He will also propose effective mitigation strategies for a successful transition to continuous bioprocessing.