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 Kleenpak II sterile connector. This webinar will cover the design and operation of the Kleenpak 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 Kleenpak 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 Allegro™ 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 Allegro MVP single-use system and the Allegro 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.
상향 제조에서 전용 기술이 이전보다 널리 사용됨에 따라 견고성, 생산성 및 전반적인 사용 편의성 측면의 결점이 주목 받고 있습니다. 전용 바이오리액터 시스템에는 움직이는 부품(교반 시스템), 여러 변수 측정 및 제어 장치, 여러 가스 및 유체 추가/회수 포트를 통합하여 사용 중에 예상되는 서비스 수명 동안 100% 유체/가스 무결성을 유지하는 전용 바이오컨테이너로 만들어야 한다는 특수한 요구 사항이 있습니다.
Pall Corporation은 "차세대" 고성능 전용 바이오리액터 시스템의 필요성을 인식하고 XRS 20 바이오리액터 시스템을 출시했습니다. 이 제품은 새로운 "이중 축" 록커 스타일 바이오리액터로서 시드 트레인(접종 증식), 소규모 GMP 작업(2 - 20 L 배양액량)에서부터 고기능 제어 시스템이 필요한 일반 실험 용도에 이르기까지 다양한 용도에 적합합니다. 이와 같은 새로운 시스템의 개발에 대해 설명하고, 설계에 관한 물리적 인자 성능을 살펴보고, 마지막으로 세포 밀도, 배양 수명 및 세포 생산성에서 상당한 증가를 보인 CHO 세포 배양 검증에 대해 설명합니다.
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 Cadence™ 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 Cadence™ 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 Mustang® 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.