Due to numerous benefits, including flexibility, absence of cross contamination, and elimination of cleaning validation, single-use technology is being widely adopted by the biopharmaceutical industry, even in very critical applications, such as formulation and filling.In these applications, the drug product is typically high value and/or highly potent.Typically, a strong Quality by Design approach is in place and several leak tests are performed during single-use systems manufacturing.However, end users also need to mitigate any risk of product loss or operator exposure due to the potential risk of a single-use system leaking during drug product processing.
As part of a risk assessment and mitigation strategy, one robust approach for the end user is to perform point-of-use (in situ) leak testing of single-use assemblies using the new ポールトロニック Flowstar LGR test instrument.In this webinar, we will present an overview on how to test single-use systems with the ポールトロニック Flowstar LGR instrument and the expected benefits from the end user's perspective.
Participants will learn:
How to perform a point-of-use leak testing on single-use systems.
Risk-based approach for single-use technologies implementation in critical process applications.
The biopharmaceutical industry has implemented single-use and/or disposable technologies in bioprocesses for the past ten years with clear benefits in terms of reduced product cost of goods, capital expenses and facility footprint while process productivity and flexibility is increased.The same key benefits are also expected from the implementation of continuous bioprocessing.There is an obvious synergy existing between those two approaches for biotech processes.Disposable technologies facilitate process step integration and further reduce process cost when implemented for an extended period of time within a continuous bioprocess.
Pall Life Sciences has a number of cutting edge technologies that facilitate process intensification and continuous processing to support the adoption of continuous downstream processing in biotech applications.These technologies include the BioSMB® multicolumn continuous chromatography platform and the ケイデンス™ Inline Concentrator.
On June 15, 2015 Pall Corporation announced the signing of an exclusive license for acoustic wave separation (AWS), a disruptive technology from FloDesign Sonics (FDS) for cell culture clarification for both fed-batch and perfusion applications.The AWS technology enables very high-efficiency continuous removal of the cells in a closed system without centrifugation, thereby streamlining a challenging step in the biologics manufacturing process within a small operating footprint.The technology will complement Pall's industry-leading スタックス depth filtration products to enable continuous clarification of cell culture, enabling integration of the bioreactor with downstream processing.
This webinar will provide a brief overview of continuous processing technologies and will highlight the AWS technology.
Typically column packing is the responsibility of a few specialist operators and has been regarded almost as an art by some observers.When the artistry fails, the results can be unplanned plant downtime, loss of product or sorbent as well as inefficient use of resources.Couple this with difficulties in transferring methodologies to other geographies and coping with loss of skill through high staff turnover then it’s not difficult to see why column operations are regarded with apprehension.To mitigate these risks the biopharmaceutical industry is moving toward an increasingly science based approach.The role of automation in this move is pivotal.This webinar discusses the move to automation and how it delivers solutions to the challenges associated with chromatography column operations.
Pall Life Sciences invites you to learn the latest details of a new range of large scale single-use bioreactor systems specifically designed to address the needs of commercial scale biotechnology production operations.Hear directly from members of the team that developed the アレグロ™ STR range of single-use systems as they discuss in detail their approach to incorporating a large format, bottom mounted impeller into single-use bioreactor.A comparison of Computational Fluid Dynamics predictions to the actual observed mixing, mass transfer, and temperature stability characteristics at the 200 liter scale will be presented with CFD projections for the soon to be introduced 1000 liter and 2000 liter scale devices.The team will also address robustness and operational simplicity enhancements that make the アレグロ STR family ideally suited to industrial scale operations.Finally, the panel will present cell culture performance data from an industrial CHO cell line demonstrating the utility of the アレグロ STR systems in achieving the benefits of single use technology with far reduced risks and with minimal operational complexity.
As single-use technologies become more widely used in upstream, downstream and formulation and filling processes, biopharmaceutical manufacturers are continually looking for innovative and practical solutions to make secure, permanent sterile connections of large single-use systems (≥100 L) in uncontrolled environments.
Recognizing the clear need for a connector device for biomanufacturing commercial applications that involve the sterile transfer of large fluid volumes, Pall Life Sciences designed and developed the クリーンパック II sterile connector.This webinar will cover the design and operation of the クリーンパック II sterile connector and focus on the validation of this technology.Application data will also be presented from our applications R&D group along with some practical examples of how the クリーンパック II sterile connector can be successfully integrated into a variety of single-use systems across both upstream and downstream applications.
Mesenchymal stem cells (MSCs) are self-renewing cells that differentiate into several terminally-differentiated cell types.MSC’s hold the potential to cure disease and are being actively pursued in clinical trials.
For many cell therapy applications, large numbers of MSCs are needed.Expansion of adult stem cells can be difficult as they have a finite life span and multipotency can be lost.Microcarriers offer a large surface area for growth of adherent cell types within a single vessel.They increase the ratio of surface area to medium volume, facilitating use of bioreactors for MSC expansion in fewer passages.Additionally, MSC growth on microcarriers outpaces growth on traditional flatware due to expanded growth volume from cell bridging between microcarriers. .
In this webinar, we will discuss the benefits of MSC expansion on microcarriers, including attachment to microcarriers in suspension, optimizing feed strategy, and harvest.In addition to successful expansion, we will demonstrate that the characterized MSCs grown on microcarriers retain expression of surface markers, CD44, CD90, and Stro1 and maintain multipotency.
As single-use technology is moving into more complex unit operations and commercial applications, there is a need from the industry to automate single-use operations to combine the benefits of single-use processing with the reliability of automation.
The アレグロ™ MVP single-use system offers fully automated processing across a range of direct flow filtration (DFF) applications and procedures requiring pH adjustment (eg low pH hold for virus inactivation, media/buffer preparation).The flexible step configurator software on the system allows the end user to create many different recipes and process steps.The system capabilities will be shown using the example of a buffer preparation with pH adjustment using the アレグロ MVP single-use system and the アレグロ 200 L single-use mixer.
High-throughput protein characterization has become a critical bottleneck during the development and production of biotherapeutic drugs.To help address this need, Pall ForteBio recently introduced the Octet® HTX system, a novel analytical platform that can perform up to 96 label-free protein analyses simultaneously.The presenters and panelists in the webinar will discuss the system’s design and present data on important analytical applications, including:
High throughput titer determinations (96 samples in 2 minutes).
Rapid characterization of antibody/antigen binding kinetics.
Faster growth media optimization & cell culture development for process monitoring.
Recognizing the clear need for a "next generation" of high performance single-use bioreactor systems, Pall Corporation is introducing the XRS 20 Bioreactor System, a novel “bi-axial” rocker-style bioreactor, suited for applications ranging from seed trains (inoculum expansion), small- scale GMP operations (2 to 20 L culture volume), and to general laboratory uses where high capability control systems are required.当セミナーでは、この新システムの開発についてご説明し、物理パラメータ性能や設計、CHO細胞培養バリデーションについてディスカッションを展開しながら、細胞密度、培養物の生存期間、細胞の生産性がどれほど飛躍的に向上したかについてご紹介します。
Nanoemulsions have many advantages to the pharmaceutical industry as drug delivery systems.These advantages include increased drug loading, enhanced bioavailability, protection from degradation, and controlled drug release.Additionally, the ability of nanoemulsions to enhance immune response makes them useful as vaccine adjuvants.
Large scale production of pharmaceutical nanoemulsions requires precise control of particle size and size distribution since both will determine the stability of the nanoemulsions, and greatly affect terminal sterile filtration.Due to the nature of many of these drug delivery systems (or the drug itself) terminal sterilization with heat is often not an option, and sterile filtration is employed.However, validation of sterile filtration with these solutions can require increasingly robust technical solutions.
This educational webinar will present an example of the process development of a drug delivery nanoemulsion using Microfluidics™ innovative high pressure, high shear fluid processing technology in combination with successful sterile filtration utilizing a pre-filtration step (スーポア® Grade EKV 0.2 µm rated filter) followed by sterile filtration at three different pressures (15, 30 and 60 psid) with a フロロダイン® EX Grade EDF filter.The unique capability of a Microfluidizer to produce nanoemulsions with targeted size and size distribution are demonstrated.
Developing the right industrialization strategy is critical to support a sustainable cell therapy development and commercialization program.Cell sources, stock management, and technology performance are some of the key parameters that determine the manufacturing scale required for specific product characteristics, supply chain, and business risk management.
Suzanne Farid, Professor of Biochemical Engineering at University College London, will present insights from an advanced bioprocess economics model designed by her team.This model enables rapid identification of key manufacturing parameters that drive the cost of goods for cell therapy manufacture.The model can be used to identify the most cost-effective set of technologies to implement at different manufacturing scales.
Thierry Bovy, Global Cell Therapy Product Manager at Pall Life Sciences will discuss the advantages and limitations of implementing the different technology options across the drug development pathway.
In this webinar, participants will learn how to:
Map the factors influencing your bioprocess scale.
Design optimized manufacturing strategies for allogeneic cell-based therapies.
Evaluate and select the most cost-effective technology according to the lot size.
Thorough evaluation of emerging technologies is a key determinant for identifying process improvement opportunities in existing and future bioprocess facilities.Successful implementation through process coupling and/or elimination of non-value added processing steps could result in both novel facility-fit solutions with alternative processing options and provide major cost savings at clinical and commercial scales.
In this context, a collaborative study has been undertaken to demonstrate the use of ケイデンス™ Inline Concentrator (ILC) linked to several potential processing steps such as perfusion, pre-capture chromatography, in-process volume reduction, and UF/DF.ILC is a disposable, self-contained, and easy to use, single-pass tangential flow filtration (TFF) device.The feasibility and performance of ILC modules were successfully evaluated and demonstrated over a wide range of feed streams at varying concentrations and process temperatures.
Developing a purification process using conventional methods is less and less compatible with biopharm industry challenges in terms of timelines and cost constraints.High Throughput Process Development (HTPD) for screening chromatography sorbents and multiple process conditions, based on a Design of Experiment (DoE) approach, has become a standard that enables saving time and sample, while improving process efficiency.
The two case studies presented in this webinar describe the development of a three-step process strategy for the purification of two recombinant proteins using a platform that includes AcroPrep™ ScreenExpert 96-well filter plates, robotics and high throughput analytics.This educational webinar will demonstrate the benefits of HTPD for identifying purification strategies with minimal sample and time consumption.
Fully automated single-use tangential flow filtration (SUTFF) system, coupled with the ケイデンス™ single-use TFF modules brings real-time process control, monitoring, flexibility and reliability in manufacture.The webinar presents Pall Life Sciences’ design approach for SUTFF and the process economics analysis to show significant utilities, cost, and time savings as it compares to conventional re-use TFF.
Membrane chromatography products are increasingly being adopted in process development and manufacturing of several new viral products both in capture and flow through mode.Membrane processes have been proven to outperform conventional chromatography sorbents in terms of capacity and processing time of viruses ranging in size from 20 nm to well over 150 nm with high yield and throughput, are easy to scale-up, economical and offer efficient contaminant removal.
This educational webinar will discuss a high throughput process development (HTPD) approach using ムスタング® membrane to define the optimal operating conditions resulting in the best quality of the virus product and demonstrate the predictive power of this methodology as applied to the purification of influenza virus.The case study provides us insight into the economic modeling and confirms that membrane chromatography is a valuable alternative for the purification of influenza virus from clarified cell culture harvest, allowing for faster, simpler and more cost efficient processing.
Single-use systems have been increasingly used in upstream and downstream biomanufacturing processes.Advances in technologies have led to the introduction of single-use solutions for final fill operations.This webinar will show how a completely disposable filling line can be realized by integration of novel technologies for final filling applications.
One of the key components of the fluid path development has been an innovative polymeric single-use filling needle.We will review key aspects of the development of this filling technology and provide data regarding filling accuracy and repeatability, with fluids of different properties & different type of dosing technologies and how it compares to its stainless steel equivalent.In a user case study, Dr. Jean-Pascal Zambaux of Disposable-Lab will discuss how using these technology developments has led to a completely disposable filling line.