More Biotech Webinars
Our webinars keep you informed on the latest products and technologies, current industry topics, the latest trends and a range of innovations and solutions to help continuously improve your processes.
May 2019

As gene therapies move toward commercialization, a robust, scalable and affordable manufacturing process is critical to ensure these novel therapies reach the patient and that a pipeline of clinical assets can be rapidly developed. In this webinar, we will present an end user case study which illustrates how Freeline Therapeutics and Pall Biotech worked together to set up an end-to-end manufacturing process to support Freeline’s pipeline of adeno-associated virus products. Attendees will learn how integrated solutions enable efficient viral vector manufacturing, the tools available to simplify and streamline your process while reducing risk and key lessons learnt around facility set up.


Tuesday, May 07, 2019
8:00 a.m. (PDT) - 11:00 a.m. (EDT) - 4:00 pm (BST) - 5:00 pm (CEST)


Tuesday, May 14, 2019
8:00 a.m. (BST) - 09:00 a.m. (CEST) - 12:30 pm (IST) - 04:00 pm (JST) 


Duration: 1 hour

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April 2019

With the progress in developing new viral vector systems guided by safety, specificity and potency considerations, several gene and cell-based therapies are now close to being clinically approved and commercially available to treat genetic diseases. These viral vectors systems are based on the production of mainly adeno-associated viruses (AAV) and lentiviruses by transient transfection of human embryonic kidney (HEK)-293 derived producer cell lines.


One of the bottlenecks that needs to be addressed is optimization of production during Upstream Process Development to simplify manufacturing scale-up of therapeutic viral vectors to support advanced clinical trials and commercialization. This is why, virus vector production using the right transient transfection approach and combined cell culture system is crucial to achieve process performance, while complying with Quality requirements for process development and clinical-grade manufacturing. With the available quality grades of PEI, PEIpro♦, PEIpro♦-HQ and recently launched PEIpro♦-GMP, Polyplus-transfection♦ offers a complete and reliable PEI transfection method that guarantees direct scalability and seamless transition from process development up to large-scale clinical-grade viral vector manufacturing.

 

Join this webinar to hear from experts in transfection, advanced culture systems and gene therapy viral vector manufacturing to optimize your process development and simplify your manufacturing scale-up.

 

  • Improve transfection step efficiency to optimise viral vector production
  • Simplify and introduce flexibility to your vector scale-up process
  • Ensure reproducability across various platforms
  • Improve performance through reliable PEI sourcing
  • Comply with raw material quality requirements for ATMPs throughout the transition to therapeutic/clinical-grade viral vector production
  • Anticipate challenges with large-scale manufacturing
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As the number of unit operations in a continuous bioprocess running in parallel increases, automation becomes increasingly important. Close collaboration between process specialists and automation engineers is required to deliver a robust control strategy capable of maintaining the process for long periods of time. This webinar will explore the challenges of automating a continuous downstream process with a case study example. The collaboration between Pall and CPI will be presented. Both parties will present, giving both supplier and end user perspectives. Participants will learn the challenges when implementing a continuous platform in a bioprocess, pros and cons of automating the platform, and the steps to take to implement a continuous platform.


Monday, April 29, 2019
08:00 a.m. PDT - 11:00 a.m. EDT - 04:00 p.m. BST - 05:00 p.m CET


Thursday, May 2, 2019

08:00 a.m. BST - 09:00 a.m. CET - 01:30 p.m. IST - 05:00 p.m. JST 


Duration: 1 hour

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March 2019
Streamline Your Protein Purification Platform

Biotech | Pall Corporation webinar series

High capacity capture, along with selective and efficient polishing steps are the main criteria for a robust protein purification platform. Up to now, purification processes have traditionally acted as a barrier to innovation due to:
 

  • The long screening and optimization process development of each process, limiting changes to existing processes
  • The lack of a universal purification process
  • Low capacity of mixed mode chromatography sorbents which limits their use in-spite of their unrivalled resolution


In this webinar, the benefits of Pall’s chromatography process, which features Kaneka  KanCapA♦, Mustang® Q and CMM HyperCel™ sorbents will be presented with a focus on the specificity of CMM HyperCel sorbent versus traditional cation exchangers or other mixed mode resins. This three-step process can be operated without any need for diafiltration or dilution between the chromatography steps.


We will demonstrate the robust performance of the CMM HyperCel sorbent within a streamlined batch process, which consistently provided purified mAb with high yield and purity  > 95% yield with < 0.5% aggregates and < 15ppm HCP).  The results of our investigation show the versatility of CMM HyperCel sorbent which provides flexibility within the development of a process whilst delivering high yield and purity of mAbs and recombinant proteins.

Duration: 1 hour

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November 2018
Process Economics of Cell Harvesting Technologies

Biotech | Pall Corporation webinar series

  • The advantages and disadvantages of depth filtration vs cake filtration vs acoustic separation
  • Which process parameters affect the performance of each technology
  • How to identify the most suitable cell harvesting technology for your process


Which cell culture harvesting technology to use in a monoclonal antibody (mAb) process is decided early in process development and as each cell culture has unique characteristics, it is important that process developers have enough information to choose the right technology at this early stage. In this webinar the three most important cell culture harvesting platforms are described and compared on a technical, ease of handling and cost basis. The criteria to choose the best fit technology to get the strongest performing harvest process are explained.
 

This webcast is being offered twice. Please select the webcast that is best for your time zone.

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  • Accelerate time to market for adenovirus manufacturing
  • Design the process for scalability
  • Reduce downstream processing time from 3-4 days to 1 day


With several recent FDA approvals and a strong drug pipeline, the gene therapy market is coming of age and providing new hope for patients. As demand for these new therapies increases, a robust and scalable manufacturing process is critical. In this webinar, we will present an end user case study which illustrates the challenges and solutions to scale both the upstream and downstream process steps required to manufacture adenoviruses.

 

This webcast is being offered twice. Please select the webcast that is best for your time zone.

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June 2018
Driving Quality and Responsiveness in Single-Use Technologies

Biotech | Pall Corporation webinar series

Single-use technologies require a shift of responsibility from biomanufacturers to suppliers to enable production of safe and reliable drugs. One of the pre-requisites for efficient supply is to have standardized processes to design and manufacture single-use systems. We have developed a unique design, quality and business tool to drive quality and responsiveness, and to support standardization of single-use technologies.

Dr Hélène Pora will take you through the functionalities of this system and demonstrate what benefits it brings to end users when implementing single-use technologies in a regulated environment.

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April 2018
Ensure Integrity of Your Single-Use Systems

Biotech | Pall Corporation webinar series

In this 45-minute webinar, experts from Pall Biotech will discuss the approach and strategy to ensure the highest level of assurance of integrity of SUS in drug substances and drug products processes. They will take into account the life cycle of the SUS; from its manufacturing to end user’s deployment and use.

 

You will learn about:

 

  • The industry trends and recommended approach for the assurance of integrity of single-use systems
  • Available solutions for the highest level of assurance of integrity of SUS
  • A new integrity test for Allegro 2D biocontainer assemblies

 

Hélène PORA (moderator) - Vice President Technical Communication & Regulatory Strategy, Pall Biotech.

 

Hélène leads the technical training and regulatory documentation support within Biotech. She has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in quality and regulatory aspects.

She has over 30 years of experience working for the biopharmaceutical industry, the last 27 years within Pall.

 

 

Nathalie PATHIER (speaker) - Global Product Manager for Single-Use Technologies, Pall Biotech.

 

Nathalie has more than 25 years of experience working on bioprocessing. She joined Pall as a Marketing Manager in 2004 and has been dealing with product management in tangential flow filtration and single-use systems since 2009.

She was previously Project Manager in the biopharmaceutical industry where she designed and implemented engineered process solutions for downstream processing.

 

 

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March 2018

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.

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Advances in Aseptic Single-Use Fluid Handling and Management

Biotech | Pall Corporation webinar series

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.

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