Tx Single Use Seminar Jun09
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TangenX develops single-use and reusable tangential flow filtration cassettes. Their Sius cassettes are single-use and come in a range of sizes from laboratory to process scale. The cassettes use validated manufacturing processes and FDA approved materials. TangenX also offers NovaSet reusable cassettes that are cleaned and reused for multiple runs.
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Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
Normal Flow Filtration: Design and Scale Up
This presentation explores bioprocessing filtration best practices, including design and scale up methods. You will learn:
• What is filtration?
• Filter capacity and fouling models
• Filter sizing approaches
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/remotevisit
Membrane Chromatography Solutions for Single-Use, Intensified mAb Purification
Participate in the interactive webinar: http://bit.ly/NatrixChromMSIG
Explore our webinar library: www.emdmillipore.com/webinars
Improve productivity, flexibility, and economics of mAb purification process with intensified, single-use membrane chromatography.
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) Virus
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
Membrane Separation Processes
i am pursuing B.Tech from MIET, Meerut with Chemical Engineering, Meerut.
Implementing a Fully Single-Use, Integrated mAb Biosimilars Purification Plat...
Access the interactive recording here: https://bit.ly/2DONZaQ
Webinar summary:
1000L-scale implementation of fully connected, disposable, advanced DSP platform for next generation mAb production.
Within the biopharmaceutical industry, there is a significant shift toward higher productivity processes resulting in improved economics without compromising robustness. Therefore, integrated continuous production technologies are of greatest interest.
Next Generation Biopharmaceutical Downstream Process is a European-funded collaborative project that aims at implementing a fully integrated manufacturing platform for biosimilar mAb based on continuous chromatography, in combination with single-use disposable technologies for all unit operations of DSP on pilot/small production scale together with incorporation of advanced analytical tools.
In this webinar, you will see:
* new DSP purification template producing > 3.3 kg of mAb in 2.5 days in less than 30m²
* proof of concept for the mAb manufacturing of tomorrow
Single-Use Tangential Flow Filtration for Closed Processing
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Scalability of a Single-use Bioreactor Platform for Biopharmaceutical Manufac...
Increasing adoption of single-use technologies for bioprocessing along with higher titers from cell culture bioreactor processes has allowed clinical and even commercial manufacturing to be successfully performed in 2000 L-scale single-use bioreactors. Several biopharmaceutical manufacturers have successfully adopted single-use bioreactors for production. However, information about process scalability from glass bioreactors to 2000 L single-use bioreactors for different types of CHO cell lines is not widely available. Here we provide an overview of the key
differences between single-use and conventional stainless steel bioreactors, and highlight factors that are employed while scaling-up from small-scale glass bioreactors to 2000 L-scale single-use bioreactors. Several case studies focusing on process performance across scales into single-use bioreactors are provided. This analysis confirms that the 2000 L-scale single-use bioreactorsystem can be robustly employed for biopharmaceutical manufacturing.
Key to Successful Formulation Development for Lipid Based RNA Delivery and Va...
In this webinar, we will discuss:
• The application of RNA therapeutics and the different drug delivery routes used in the clinic.
• Design principles for developing lipids-based RNA formulations.
• Critical parameters to consider for cost effective development and consistent performance of RNA therapeutics and vaccines.
RNA therapeutics are changing the way we address diseases. Applications range from gene therapy, oncology, to vaccines for infectious diseases such as COVID-19.
The performance of RNA therapeutics critically depends on its formulation. Key decisions have to be made early on in the drug development process; choosing the appropriate drug delivery method and novel excipients. Raw material source and judicious choice of chemistry, ultimately determine the quality of novel lipid excipients which, in turn, has a big impact on the performance, reproducibility, costs, and regulatory approval timelines. This webinar will propose solutions to maximize the probability of success while formulating RNA therapeutics and vaccines.
Participate in the interactive webinar now: https://bit.ly/2xXMZlm
Explore our webinar library: www.emdmillipore.com/webinars
Chromatography: Chromatographic strategies for IVIG purification – Part 2
Immunoglobulin G (IgG) is an important plasma-derived product used to treat patients with primary immunodeficiency or auto-immune diseases. Industrial plasma fractionators are increasingly using chromatography as an essential step of the purification of IgG for therapeutic use. Therapeutic IgG should meet quality criteria including a low residual level of contamination with other proteins such as IgA, IgM, proteolytic enzymes, or Factor XI/XIa. We have developed a chromatographic method using our commercially available Fractogel® EMD TMAE(M) resin that allows the purification of plasma-derived IgG in a negative mode, whereby contaminants such as IgA and IgM are adsorbed on the resin and further eliminated by subsequent elution prior to column regeneration and re-use for the next cycle. In this study we show a systematic approach in chromatographic process development to determine the optimal purification conditions for the plasma-derived IgG based on 5%-pH 5.5 caprylic acid treatment (CA-IgG). The reliability and consistency of the resin in IgG purification was evaluated up to 200 chromatographic cycles.
Results show that under worst-case conditions of a crude IgG feed with high linear flow rate, there is powerful removal of both IgA and IgM from the IgG flow-through corresponding to 75-90 mg of proteins/mL of resin. The robustness of Fractogel® EMD TMAE(M) resin at pH 6.0 was confirmed over 10 cycle runs, and the wash fraction was proportionally enriched in IgA and IgM, confirming the adsorption on the resin. The recovery in IgG subclasses was good, and improvement of IgG purity from around 82% to around 97% purity was achieved. Furthermore, there was no generation of thrombogenicity during the chromatography based on several assays including TGA. The optimal chromatographic conditions/parameters were confirmed with the use of a controlled IgG with a loading close to 199 mg of IgG/ml of resin. Finally, in the 200-cycle study, Fractogel® EMD TMAE(M) resin demonstrated excellent resistance for over 201 cycles in its capacity to reproducibly remove IgA and IgM from a crude CA-IgG preparation, showed good recovery of IgG without affecting the IgG sub-class distribution, and even suggested a potential chromatographic removal of thrombogenic factors developing in the CA-IgG feed over time.
In this webinar, you will learn:
- How to systematically set up an IVIG purification strategy.
- How to evaluate the quality of purified IVIG.
- How to confirm the robustness of an upgraded IVIG purification process.
Technology Trends in Bioprocessing Purification
This presentation reviews current trends in bioprocessing purification and includes key considerations for continuous processing and connected polishing for monoclonal antibodies. Topics include:
• Market trends and the evolution of next-generation processes
• Intensified capture processing
• Continuous virus inactivation
• Connected flow-through polishing
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
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- 38. Product Support – Product Use
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