VacChina 2011 Opening Remark
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Dr. Priyabrata Pattnaik discusses the growing global vaccines market, noting vaccines are the most cost-effective healthcare intervention. While each vaccine process is unique, there is scope for innovation. The worldwide vaccines market is growing at 8% annually, with unmet demand in developing countries. Emerging markets are evolving faster, prompting vaccine manufacturers to expand their capabilities to address these new markets. Growth in emerging countries can occur through building local production capacity that meets global quality standards, but vaccine manufacturing remains a complex, capital-intensive process that requires high GMP compliance. Assessing and managing risks while balancing innovation, speed and quality is key.
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- A depth filtration clarification process achieved around 70% DNA clearance while recovering approximately 70
Process development considerations for quality and safety of vaccines
The document discusses several factors that can impact vaccine quality and safety during development, including:
1) Bioburden control is important to control contamination during manufacturing and avoid issues in later stages. Key areas are raw materials, equipment cleaning, and open processing steps.
2) Operating conditions for tangential flow filtration, such as pressure and flow rates, can cause product aggregation or degradation if not optimized.
3) Residual DNA from cell substrates must be removed through processes like nuclease treatment to very low levels due to potential safety concerns.
4) Excipient quality can impact drug product safety, so their selection and control is a critical quality attribute during development.
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...Dr. Priyabrata Pattnaik
Presented at DCVMN 15th Annual General Meeting, 27-October-2014 to 29-October-2014. New Delhi, India. The presentation can be downloaded from the following site.
http://www.dcvmn.org/sites/default/private_files/files/Strategic%20Considerations%20for%20Implementing%20of%20SU%20(Pattnaik).pdfPandemic Vaccine Supply - Challenges & Opportunities: A Raw Materials Perspec...
Pandemic Vaccine Supply - Challenges & Opportunities: A Raw Materials Perspec...Dr. Priyabrata Pattnaik
This document discusses challenges and opportunities for ensuring adequate raw materials supply for pandemic vaccines. It identifies critical raw materials and managing inventory, supply, and communication as key issues. The presentation outlines Merck Millipore's pandemic preparedness plan, which focuses on mapping vaccine manufacturer needs, assessing its own capacity and capabilities, and strengthening internal and external communication to support pandemic response. Close collaboration between vaccine manufacturers and suppliers is emphasized to develop risk assessments, inventory plans, and communication protocols to maximize preparedness.Accelerating vaccine development and manufacturing
The document discusses ways to accelerate vaccine development and manufacturing. It proposes adopting a template and platform approach to streamline process development. A template provides a standardized starting point for each vaccine's development process. A platform accumulates expertise across multiple vaccines using common unit operations, parameters, and facilities. This approach can speed development times, lower costs, simplify supply chains, and facilitate technology transfer and manufacturing.
Merck Millipore holds vaccine technology seminar in South Korea
Merck Millipore holds vaccine technology seminar at Seoul, South Korea.
Overcoming challenges of host cell DNA removal in vaccine manufacturing
Regulatory agencies require residual host cell DNA in vaccines to be extremely low, typically below 10 pg/dose. Various methods are used to remove DNA during vaccine manufacturing, including nuclease treatment, adsorptive depth filtration, chromatography, and tangential flow filtration. Nuclease treatment with Benzonase is widely used to digest DNA but the nuclease then needs to be removed using techniques like anion exchange chromatography, gel filtration, or ultrafiltration with diafiltration to achieve over 99% clearance.
Best Practices in Nucleic Acid Removal from Vaccine Processes
Benzonase is an endonuclease enzyme that can effectively degrade DNA and RNA within 4 minutes. It is recognized for its ability to reduce the size and infectivity of residual DNA in vaccines. Treatment with Benzonase followed by filtration or chromatography can reduce DNA levels in vaccines such as those produced in Vero cells. By digesting cellular DNA, Benzonase prevents the formation of virus-DNA complexes during purification of vaccines such as AAV vaccines.
Pragmatic implementation of single use technologies to deliver clinical supply
Pragmatic implementation of single use technologies to deliver clinical supplyDr. Priyabrata Pattnaik
This document discusses implementing single-use technologies for a clinical drug supply pilot run. It summarizes:
1) A template process and pre-selected operating parameters were used to minimize process development work and reduce timelines.
2) A 100L pilot scale run was conducted using commercially available single-use systems and assemblies to scale up a downstream process developed at bench scale.
3) Comparison of bench and pilot scale runs showed similar impurity clearance, charge variant distribution, and overall yields, demonstrating successful scale up using single-use technologies.Viral-vectored vaccines: a new approach in the vaccine manufacturing process
1. Viral-vectored vaccines use recombinant viruses like adenovirus as vectors to deliver vaccine antigens.
2. Adenovirus is an efficient vaccine vector that can transduce both dividing and non-dividing cells and has a large transgene capacity.
3. While early adenovirus-based vaccines faced challenges, research has improved our understanding of adenovirus molecular biology and immunology.
Use of single-use technology in Aseptic processing of vaccines: Application s...
Use of single-use technology in Aseptic processing of vaccines: Application s...Dr. Priyabrata Pattnaik
This document discusses the use of single-use technologies in aseptic processing of vaccines. It notes the growing adoption of these technologies driven by factors like new facility design, retrofitting existing operations, and a growing range of applications. Some key challenges with balancing product and operator safety are discussed. The document also covers regulatory requirements and considerations for validation of these systems. Examples of using single-use technologies for activities like formulation, filling, filtration and powder handling are provided.More from Dr. Priyabrata Pattnaik (15)
Development of Production and Purification Platformform for Influenza Vaccine
Development of Production and Purification Platformform for Influenza Vaccine
Production and purification of Viral vectors for gene and cell therapy appli...
Production and purification of Viral vectors for gene and cell therapy appli...
Development of a production and purification platform for VLP vaccine candidates
Development of a production and purification platform for VLP vaccine candidates
Production and Purification of Virus Like Particle (VLP) based Vaccine
Production and Purification of Virus Like Particle (VLP) based Vaccine
Process development considerations for quality and safety of vaccines
Process development considerations for quality and safety of vaccines
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...
Pandemic Vaccine Supply - Challenges & Opportunities: A Raw Materials Perspec...
Pandemic Vaccine Supply - Challenges & Opportunities: A Raw Materials Perspec...
Accelerating vaccine development and manufacturing
Accelerating vaccine development and manufacturing
Merck Millipore holds vaccine technology seminar in South Korea
Merck Millipore holds vaccine technology seminar in South Korea
Overcoming challenges of host cell DNA removal in vaccine manufacturing
Overcoming challenges of host cell DNA removal in vaccine manufacturing
Best Practices in Nucleic Acid Removal from Vaccine Processes
Best Practices in Nucleic Acid Removal from Vaccine Processes
Pragmatic implementation of single use technologies to deliver clinical supply
Pragmatic implementation of single use technologies to deliver clinical supply
Viral-vectored vaccines: a new approach in the vaccine manufacturing process
Viral-vectored vaccines: a new approach in the vaccine manufacturing process
Use of single-use technology in Aseptic processing of vaccines: Application s...
Use of single-use technology in Aseptic processing of vaccines: Application s...
Recently uploaded
June Patch Tuesday
Ivanti’s Patch Tuesday breakdown goes beyond patching your applications and brings you the intelligence and guidance needed to prioritize where to focus your attention first. Catch early analysis on our Ivanti blog, then join industry expert Chris Goettl for the Patch Tuesday Webinar Event. There we’ll do a deep dive into each of the bulletins and give guidance on the risks associated with the newly-identified vulnerabilities.
Monitoring and Managing Anomaly Detection on OpenShift.pdf
Monitoring and Managing Anomaly Detection on OpenShift
Overview
Dive into the world of anomaly detection on edge devices with our comprehensive hands-on tutorial. This SlideShare presentation will guide you through the entire process, from data collection and model training to edge deployment and real-time monitoring. Perfect for those looking to implement robust anomaly detection systems on resource-constrained IoT/edge devices.
Key Topics Covered
1. Introduction to Anomaly Detection
- Understand the fundamentals of anomaly detection and its importance in identifying unusual behavior or failures in systems.
2. Understanding Edge (IoT)
- Learn about edge computing and IoT, and how they enable real-time data processing and decision-making at the source.
3. What is ArgoCD?
- Discover ArgoCD, a declarative, GitOps continuous delivery tool for Kubernetes, and its role in deploying applications on edge devices.
4. Deployment Using ArgoCD for Edge Devices
- Step-by-step guide on deploying anomaly detection models on edge devices using ArgoCD.
5. Introduction to Apache Kafka and S3
- Explore Apache Kafka for real-time data streaming and Amazon S3 for scalable storage solutions.
6. Viewing Kafka Messages in the Data Lake
- Learn how to view and analyze Kafka messages stored in a data lake for better insights.
7. What is Prometheus?
- Get to know Prometheus, an open-source monitoring and alerting toolkit, and its application in monitoring edge devices.
8. Monitoring Application Metrics with Prometheus
- Detailed instructions on setting up Prometheus to monitor the performance and health of your anomaly detection system.
9. What is Camel K?
- Introduction to Camel K, a lightweight integration framework built on Apache Camel, designed for Kubernetes.
10. Configuring Camel K Integrations for Data Pipelines
- Learn how to configure Camel K for seamless data pipeline integrations in your anomaly detection workflow.
11. What is a Jupyter Notebook?
- Overview of Jupyter Notebooks, an open-source web application for creating and sharing documents with live code, equations, visualizations, and narrative text.
12. Jupyter Notebooks with Code Examples
- Hands-on examples and code snippets in Jupyter Notebooks to help you implement and test anomaly detection models.
Generating privacy-protected synthetic data using Secludy and Milvus
During this demo, the founders of Secludy will demonstrate how their system utilizes Milvus to store and manipulate embeddings for generating privacy-protected synthetic data. Their approach not only maintains the confidentiality of the original data but also enhances the utility and scalability of LLMs under privacy constraints. Attendees, including machine learning engineers, data scientists, and data managers, will witness first-hand how Secludy's integration with Milvus empowers organizations to harness the power of LLMs securely and efficiently.
Taking AI to the Next Level in Manufacturing.pdf
Read Taking AI to the Next Level in Manufacturing to gain insights on AI adoption in the manufacturing industry, such as:
1. How quickly AI is being implemented in manufacturing.
2. Which barriers stand in the way of AI adoption.
3. How data quality and governance form the backbone of AI.
4. Organizational processes and structures that may inhibit effective AI adoption.
6. Ideas and approaches to help build your organization's AI strategy.
Best 20 SEO Techniques To Improve Website Visibility In SERP
Boost your website's visibility with proven SEO techniques! Our latest blog dives into essential strategies to enhance your online presence, increase traffic, and rank higher on search engines. From keyword optimization to quality content creation, learn how to make your site stand out in the crowded digital landscape. Discover actionable tips and expert insights to elevate your SEO game.
Main news related to the CCS TSI 2023 (2023/1695)
An English 🇬🇧 translation of a presentation to the speech I gave about the main changes brought by CCS TSI 2023 at the biggest Czech conference on Communications and signalling systems on Railways, which was held in Clarion Hotel Olomouc from 7th to 9th November 2023 (konferenceszt.cz). Attended by around 500 participants and 200 on-line followers.
The original Czech 🇨🇿 version of the presentation can be found here: https://www.slideshare.net/slideshow/hlavni-novinky-souvisejici-s-ccs-tsi-2023-2023-1695/269688092 .
The videorecording (in Czech) from the presentation is available here: https://youtu.be/WzjJWm4IyPk?si=SImb06tuXGb30BEH .
HCL Notes und Domino Lizenzkostenreduzierung in der Welt von DLAU
Webinar Recording: https://www.panagenda.com/webinars/hcl-notes-und-domino-lizenzkostenreduzierung-in-der-welt-von-dlau/
DLAU und die Lizenzen nach dem CCB- und CCX-Modell sind für viele in der HCL-Community seit letztem Jahr ein heißes Thema. Als Notes- oder Domino-Kunde haben Sie vielleicht mit unerwartet hohen Benutzerzahlen und Lizenzgebühren zu kämpfen. Sie fragen sich vielleicht, wie diese neue Art der Lizenzierung funktioniert und welchen Nutzen sie Ihnen bringt. Vor allem wollen Sie sicherlich Ihr Budget einhalten und Kosten sparen, wo immer möglich. Das verstehen wir und wir möchten Ihnen dabei helfen!
Wir erklären Ihnen, wie Sie häufige Konfigurationsprobleme lösen können, die dazu führen können, dass mehr Benutzer gezählt werden als nötig, und wie Sie überflüssige oder ungenutzte Konten identifizieren und entfernen können, um Geld zu sparen. Es gibt auch einige Ansätze, die zu unnötigen Ausgaben führen können, z. B. wenn ein Personendokument anstelle eines Mail-Ins für geteilte Mailboxen verwendet wird. Wir zeigen Ihnen solche Fälle und deren Lösungen. Und natürlich erklären wir Ihnen das neue Lizenzmodell.
Nehmen Sie an diesem Webinar teil, bei dem HCL-Ambassador Marc Thomas und Gastredner Franz Walder Ihnen diese neue Welt näherbringen. Es vermittelt Ihnen die Tools und das Know-how, um den Überblick zu bewahren. Sie werden in der Lage sein, Ihre Kosten durch eine optimierte Domino-Konfiguration zu reduzieren und auch in Zukunft gering zu halten.
Diese Themen werden behandelt
- Reduzierung der Lizenzkosten durch Auffinden und Beheben von Fehlkonfigurationen und überflüssigen Konten
- Wie funktionieren CCB- und CCX-Lizenzen wirklich?
- Verstehen des DLAU-Tools und wie man es am besten nutzt
- Tipps für häufige Problembereiche, wie z. B. Team-Postfächer, Funktions-/Testbenutzer usw.
- Praxisbeispiele und Best Practices zum sofortigen Umsetzen
zkStudyClub - LatticeFold: A Lattice-based Folding Scheme and its Application...
Folding is a recent technique for building efficient recursive SNARKs. Several elegant folding protocols have been proposed, such as Nova, Supernova, Hypernova, Protostar, and others. However, all of them rely on an additively homomorphic commitment scheme based on discrete log, and are therefore not post-quantum secure. In this work we present LatticeFold, the first lattice-based folding protocol based on the Module SIS problem. This folding protocol naturally leads to an efficient recursive lattice-based SNARK and an efficient PCD scheme. LatticeFold supports folding low-degree relations, such as R1CS, as well as high-degree relations, such as CCS. The key challenge is to construct a secure folding protocol that works with the Ajtai commitment scheme. The difficulty, is ensuring that extracted witnesses are low norm through many rounds of folding. We present a novel technique using the sumcheck protocol to ensure that extracted witnesses are always low norm no matter how many rounds of folding are used. Our evaluation of the final proof system suggests that it is as performant as Hypernova, while providing post-quantum security.
Paper Link: https://eprint.iacr.org/2024/257
GNSS spoofing via SDR (Criptored Talks 2024)
In the realm of cybersecurity, offensive security practices act as a critical shield. By simulating real-world attacks in a controlled environment, these techniques expose vulnerabilities before malicious actors can exploit them. This proactive approach allows manufacturers to identify and fix weaknesses, significantly enhancing system security.
This presentation delves into the development of a system designed to mimic Galileo's Open Service signal using software-defined radio (SDR) technology. We'll begin with a foundational overview of both Global Navigation Satellite Systems (GNSS) and the intricacies of digital signal processing.
The presentation culminates in a live demonstration. We'll showcase the manipulation of Galileo's Open Service pilot signal, simulating an attack on various software and hardware systems. This practical demonstration serves to highlight the potential consequences of unaddressed vulnerabilities, emphasizing the importance of offensive security practices in safeguarding critical infrastructure.
Dandelion Hashtable: beyond billion requests per second on a commodity server
This slide deck presents DLHT, a concurrent in-memory hashtable. Despite efforts to optimize hashtables, that go as far as sacrificing core functionality, state-of-the-art designs still incur multiple memory accesses per request and block request processing in three cases. First, most hashtables block while waiting for data to be retrieved from memory. Second, open-addressing designs, which represent the current state-of-the-art, either cannot free index slots on deletes or must block all requests to do so. Third, index resizes block every request until all objects are copied to the new index. Defying folklore wisdom, DLHT forgoes open-addressing and adopts a fully-featured and memory-aware closed-addressing design based on bounded cache-line-chaining. This design offers lock-free index operations and deletes that free slots instantly, (2) completes most requests with a single memory access, (3) utilizes software prefetching to hide memory latencies, and (4) employs a novel non-blocking and parallel resizing. In a commodity server and a memory-resident workload, DLHT surpasses 1.6B requests per second and provides 3.5x (12x) the throughput of the state-of-the-art closed-addressing (open-addressing) resizable hashtable on Gets (Deletes).
A Comprehensive Guide to DeFi Development Services in 2024
DeFi represents a paradigm shift in the financial industry. Instead of relying on traditional, centralized institutions like banks, DeFi leverages blockchain technology to create a decentralized network of financial services. This means that financial transactions can occur directly between parties, without intermediaries, using smart contracts on platforms like Ethereum.
In 2024, we are witnessing an explosion of new DeFi projects and protocols, each pushing the boundaries of what’s possible in finance.
In summary, DeFi in 2024 is not just a trend; it’s a revolution that democratizes finance, enhances security and transparency, and fosters continuous innovation. As we proceed through this presentation, we'll explore the various components and services of DeFi in detail, shedding light on how they are transforming the financial landscape.
At Intelisync, we specialize in providing comprehensive DeFi development services tailored to meet the unique needs of our clients. From smart contract development to dApp creation and security audits, we ensure that your DeFi project is built with innovation, security, and scalability in mind. Trust Intelisync to guide you through the intricate landscape of decentralized finance and unlock the full potential of blockchain technology.
Ready to take your DeFi project to the next level? Partner with Intelisync for expert DeFi development services today!
Presentation of the OECD Artificial Intelligence Review of Germany
Consult the full report at https://www.oecd.org/digital/oecd-artificial-intelligence-review-of-germany-609808d6-en.htm
Public CyberSecurity Awareness Presentation 2024.pptx
Cyber security awareness slides for a busisness by TreeTop Security
Digital Marketing Trends in 2024 | Guide for Staying Ahead
https://www.wask.co/ebooks/digital-marketing-trends-in-2024
Feeling lost in the digital marketing whirlwind of 2024? Technology is changing, consumer habits are evolving, and staying ahead of the curve feels like a never-ending pursuit. This e-book is your compass. Dive into actionable insights to handle the complexities of modern marketing. From hyper-personalization to the power of user-generated content, learn how to build long-term relationships with your audience and unlock the secrets to success in the ever-shifting digital landscape.
JavaLand 2024: Application Development Green Masterplan
My presentation slides I used at JavaLand 2024
Building Production Ready Search Pipelines with Spark and Milvus
Spark is the widely used ETL tool for processing, indexing and ingesting data to serving stack for search. Milvus is the production-ready open-source vector database. In this talk we will show how to use Spark to process unstructured data to extract vector representations, and push the vectors to Milvus vector database for search serving.
Skybuffer SAM4U tool for SAP license adoption
Manage and optimize your license adoption and consumption with SAM4U, an SAP free customer software asset management tool.
SAM4U, an SAP complimentary software asset management tool for customers, delivers a detailed and well-structured overview of license inventory and usage with a user-friendly interface. We offer a hosted, cost-effective, and performance-optimized SAM4U setup in the Skybuffer Cloud environment. You retain ownership of the system and data, while we manage the ABAP 7.58 infrastructure, ensuring fixed Total Cost of Ownership (TCO) and exceptional services through the SAP Fiori interface.
Astute Business Solutions | Oracle Cloud Partner |
Your goto partner for Oracle Cloud, PeopleSoft, E-Business Suite, and Ellucian Banner. We are a firm specialized in managed services and consulting.
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Monitoring and Managing Anomaly Detection on OpenShift.pdf
Monitoring and Managing Anomaly Detection on OpenShift.pdf
Generating privacy-protected synthetic data using Secludy and Milvus
Generating privacy-protected synthetic data using Secludy and Milvus
Best 20 SEO Techniques To Improve Website Visibility In SERP
Best 20 SEO Techniques To Improve Website Visibility In SERP
HCL Notes und Domino Lizenzkostenreduzierung in der Welt von DLAU
HCL Notes und Domino Lizenzkostenreduzierung in der Welt von DLAU
zkStudyClub - LatticeFold: A Lattice-based Folding Scheme and its Application...
zkStudyClub - LatticeFold: A Lattice-based Folding Scheme and its Application...
WeTestAthens: Postman's AI & Automation Techniques
WeTestAthens: Postman's AI & Automation Techniques
Dandelion Hashtable: beyond billion requests per second on a commodity server
Dandelion Hashtable: beyond billion requests per second on a commodity server
A Comprehensive Guide to DeFi Development Services in 2024
A Comprehensive Guide to DeFi Development Services in 2024
Presentation of the OECD Artificial Intelligence Review of Germany
Presentation of the OECD Artificial Intelligence Review of Germany
Public CyberSecurity Awareness Presentation 2024.pptx
Public CyberSecurity Awareness Presentation 2024.pptx
Digital Marketing Trends in 2024 | Guide for Staying Ahead
Digital Marketing Trends in 2024 | Guide for Staying Ahead
JavaLand 2024: Application Development Green Masterplan
JavaLand 2024: Application Development Green Masterplan
Building Production Ready Search Pipelines with Spark and Milvus
Building Production Ready Search Pipelines with Spark and Milvus
Astute Business Solutions | Oracle Cloud Partner |
Astute Business Solutions | Oracle Cloud Partner |
VacChina 2011 Opening Remark
- 1. Dr. Priyabrata Pattnaik Biomanufacturing Sciences Network Merck Millipore
- 2. Vaccines is the most cost effective health-care intervention available
- 3. - Each vaccine process is unique - Scope for high degree of innovation
- 4. Worldwide Vaccines market is growing at 8% CAGR
- 5. And…. there is Unmet demand in developing countries
- 6. ….things are changing…… Emerging markets are evolving faster Vaccine manufacturers expanding their capabilities to address need of emerging market
- 7. • Need to increase the immunization coverage rates for both pediatric and adolescents / adults vaccines • Huge demand for traditional/ classical vaccines, low cost but high volume demand
- 8. Growth in emerging countries can happen by - Building production capacity - Matching global quality standards
- 9. The challenge….. • Vaccine manufacturing is - critical and complex - requires capital-intensive capabilities - high GMP standards
- 10. Increasing understanding of - Product - Process - Quality standards - Clinical impact
- 11. Assessing Risk and Managing Risk
- 12. Striking the balance between - Innovation - Speed - Quality
- 13. Bottom line….. Vaccine awareness is key to success.
- 14. Thank You