The challenge:
Can you improve the yield and impurity levels while streamlining the production process?
How we said yes:
Baseline Experimentation revealed impurity and yield problems and an R&D program was launched to address the issues.
Key Considerations & Case Study for Building a cGMP Biomanufacturing FacilityMilliporeSigma
Every biopharma executive must make important decisions early in clinical development. One of these decisions includes defining the commercial manufacturing strategy for their biopharmaceutical and whether it makes business sense to build their own cGMP biomanufacturing facility. We have gained significant expertise throughout the design, build and ongoing operations of the Biodevelopment Center in Martillac, France that could prove invaluable to companies that are considering whether to build their own cGMP facility or outsource to a contract manufacturing organization. In this webinar, our experts share some key considerations for designing, building and operating an agile and flexible cGMP biomanufacturing facility successfully, safely, and profitably.
In this webinar, you will learn:
- How to design and build a flexible and agile facility
- The regulatory requirements for the facility
- How we have converted a stainless steel cGMP bioproduction facility in Martillac, France into a state-of-the-art, fully single-use cGMP facility
The challenge:
Can you improve the yield and impurity levels while streamlining the production process?
How we said yes:
Baseline Experimentation revealed impurity and yield problems and an R&D program was launched to address the issues.
Key Considerations & Case Study for Building a cGMP Biomanufacturing FacilityMilliporeSigma
Every biopharma executive must make important decisions early in clinical development. One of these decisions includes defining the commercial manufacturing strategy for their biopharmaceutical and whether it makes business sense to build their own cGMP biomanufacturing facility. We have gained significant expertise throughout the design, build and ongoing operations of the Biodevelopment Center in Martillac, France that could prove invaluable to companies that are considering whether to build their own cGMP facility or outsource to a contract manufacturing organization. In this webinar, our experts share some key considerations for designing, building and operating an agile and flexible cGMP biomanufacturing facility successfully, safely, and profitably.
In this webinar, you will learn:
- How to design and build a flexible and agile facility
- The regulatory requirements for the facility
- How we have converted a stainless steel cGMP bioproduction facility in Martillac, France into a state-of-the-art, fully single-use cGMP facility
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...MilliporeSigma
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Addressing Raw Material Handling Challenges by Dry GranulationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2NXmi8O
Caking and clumping of pharmaceutical raw materials have a negative impact on manufacturing efficiency. Learn which benefits dry granulation provides and how granulated raw materials facilitate processability, speed up manufacturing processes and increase operator safety.
Buffers, salts and stabilizing chemicals are used in multi-ton quantities during pharmaceutical manufacturing. The handling of such quantities can be challenging: caking and clumping of chemicals, dust formation and laborious weighing have a negative impact on manufacturing efficiency and may even lead to process interruptions, quality deviations and operator safety risks. In many cases, these limitations can be overcome by granulated material.
Learn which benefits dry granulation by roller compaction provides and how granulated raw materials facilitate processability, speed up manufacturing processes and increase operator safety.
In this webinar, you will learn:
• Which effects clumping and caking of pharmaceutical raw materials can have on operations
• How dry granulation of raw materials can help overcome these issues
• Which technical and chemical parameters are key for a suitable granulation outcome
Case Study: Telecom Equipment Manufacturer Enhances QMS to Streamline Returns...Paul Adamson
In order to meet increasing customer demand, a Fortune 500 Telecom Equipment Manufacturer added another remanufactured product line to their Special Customer Operations returns center. Spinnaker, who managed the client’s returns functions, was asked to provide more product processing; including testing and light manufacturing work. They were asked to evaluate the existing Digital Equipment Facility Testing (DEFT) lab protocols and product inspection processes to streamline operations and create new material workflows.
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...MilliporeSigma
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Addressing Raw Material Handling Challenges by Dry GranulationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2NXmi8O
Caking and clumping of pharmaceutical raw materials have a negative impact on manufacturing efficiency. Learn which benefits dry granulation provides and how granulated raw materials facilitate processability, speed up manufacturing processes and increase operator safety.
Buffers, salts and stabilizing chemicals are used in multi-ton quantities during pharmaceutical manufacturing. The handling of such quantities can be challenging: caking and clumping of chemicals, dust formation and laborious weighing have a negative impact on manufacturing efficiency and may even lead to process interruptions, quality deviations and operator safety risks. In many cases, these limitations can be overcome by granulated material.
Learn which benefits dry granulation by roller compaction provides and how granulated raw materials facilitate processability, speed up manufacturing processes and increase operator safety.
In this webinar, you will learn:
• Which effects clumping and caking of pharmaceutical raw materials can have on operations
• How dry granulation of raw materials can help overcome these issues
• Which technical and chemical parameters are key for a suitable granulation outcome
Case Study: Telecom Equipment Manufacturer Enhances QMS to Streamline Returns...Paul Adamson
In order to meet increasing customer demand, a Fortune 500 Telecom Equipment Manufacturer added another remanufactured product line to their Special Customer Operations returns center. Spinnaker, who managed the client’s returns functions, was asked to provide more product processing; including testing and light manufacturing work. They were asked to evaluate the existing Digital Equipment Facility Testing (DEFT) lab protocols and product inspection processes to streamline operations and create new material workflows.
Our in-house compression, coating and encapsulation expertise from pilot to commercial scale allows for a successful tech-transfer process into commercial production. We can consistently provide product with your desired specifications and product performance characteristics.
POWERED BY PERFORMANCE OurTyrone plant has a long history of satisfying customers who demand quick turnaround, superior products, scale-up/scale-down flexibility and a wide range of industry experience. The ISO-9000 and RC-14000-registered facility sits on 120 acres in a small town, employs more than 150 area residents and boasts an excellent safety record.
Aarti Pharmalabs Ltd specializes in the clinical phase and commercial production of APIs and NCEs, intermediates, regulatory starting materials, key building blocks and xanthine derivatives. Our offerings include process R&D, analytical method development and validations, stability studies, scale-up and process optimization, process validations and commercial production. The quality and purity of our products have enabled us to be the leading Active Pharmaceutical ingredients manufacturers in India.
Implementation of Business Process Reengineering in Thermax Ltd.Pramod Patil
Implementation of Business Process Reengineering in Thermax Ltd. to achieve dramatic improvements in critical, contemporary measures of performance such as cost, quality, service and speed by the fundamental rethinking and radical redesign of business processes
We operate in the area of specialised automation engineering, providing automatic parts handling equipment for high volume production in cosmetics, pharmaceutical, electronics, food and metal working industries - anywhere, where there is a need to automate the handling and orientation of component parts.
RNA are at the forefront of automation technology, delivering market leading solution to the world’s most successful manufacturers and aiming to give customers a competitive advantage.
Software Delivery At the Speed of AI: Inflectra Invests In AI-Powered QualityInflectra
In this insightful webinar, Inflectra explores how artificial intelligence (AI) is transforming software development and testing. Discover how AI-powered tools are revolutionizing every stage of the software development lifecycle (SDLC), from design and prototyping to testing, deployment, and monitoring.
Learn about:
• The Future of Testing: How AI is shifting testing towards verification, analysis, and higher-level skills, while reducing repetitive tasks.
• Test Automation: How AI-powered test case generation, optimization, and self-healing tests are making testing more efficient and effective.
• Visual Testing: Explore the emerging capabilities of AI in visual testing and how it's set to revolutionize UI verification.
• Inflectra's AI Solutions: See demonstrations of Inflectra's cutting-edge AI tools like the ChatGPT plugin and Azure Open AI platform, designed to streamline your testing process.
Whether you're a developer, tester, or QA professional, this webinar will give you valuable insights into how AI is shaping the future of software delivery.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Slack (or Teams) Automation for Bonterra Impact Management (fka Social Soluti...Jeffrey Haguewood
Sidekick Solutions uses Bonterra Impact Management (fka Social Solutions Apricot) and automation solutions to integrate data for business workflows.
We believe integration and automation are essential to user experience and the promise of efficient work through technology. Automation is the critical ingredient to realizing that full vision. We develop integration products and services for Bonterra Case Management software to support the deployment of automations for a variety of use cases.
This video focuses on the notifications, alerts, and approval requests using Slack for Bonterra Impact Management. The solutions covered in this webinar can also be deployed for Microsoft Teams.
Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
UiPath Test Automation using UiPath Test Suite series, part 3DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 3. In this session, we will cover desktop automation along with UI automation.
Topics covered:
UI automation Introduction,
UI automation Sample
Desktop automation flow
Pradeep Chinnala, Senior Consultant Automation Developer @WonderBotz and UiPath MVP
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Securing your Kubernetes cluster_ a step-by-step guide to success !KatiaHIMEUR1
Today, after several years of existence, an extremely active community and an ultra-dynamic ecosystem, Kubernetes has established itself as the de facto standard in container orchestration. Thanks to a wide range of managed services, it has never been so easy to set up a ready-to-use Kubernetes cluster.
However, this ease of use means that the subject of security in Kubernetes is often left for later, or even neglected. This exposes companies to significant risks.
In this talk, I'll show you step-by-step how to secure your Kubernetes cluster for greater peace of mind and reliability.
Connector Corner: Automate dynamic content and events by pushing a buttonDianaGray10
Here is something new! In our next Connector Corner webinar, we will demonstrate how you can use a single workflow to:
Create a campaign using Mailchimp with merge tags/fields
Send an interactive Slack channel message (using buttons)
Have the message received by managers and peers along with a test email for review
But there’s more:
In a second workflow supporting the same use case, you’ll see:
Your campaign sent to target colleagues for approval
If the “Approve” button is clicked, a Jira/Zendesk ticket is created for the marketing design team
But—if the “Reject” button is pushed, colleagues will be alerted via Slack message
Join us to learn more about this new, human-in-the-loop capability, brought to you by Integration Service connectors.
And...
Speakers:
Akshay Agnihotri, Product Manager
Charlie Greenberg, Host
JMeter webinar - integration with InfluxDB and GrafanaRTTS
Watch this recorded webinar about real-time monitoring of application performance. See how to integrate Apache JMeter, the open-source leader in performance testing, with InfluxDB, the open-source time-series database, and Grafana, the open-source analytics and visualization application.
In this webinar, we will review the benefits of leveraging InfluxDB and Grafana when executing load tests and demonstrate how these tools are used to visualize performance metrics.
Length: 30 minutes
Session Overview
-------------------------------------------
During this webinar, we will cover the following topics while demonstrating the integrations of JMeter, InfluxDB and Grafana:
- What out-of-the-box solutions are available for real-time monitoring JMeter tests?
- What are the benefits of integrating InfluxDB and Grafana into the load testing stack?
- Which features are provided by Grafana?
- Demonstration of InfluxDB and Grafana using a practice web application
To view the webinar recording, go to:
https://www.rttsweb.com/jmeter-integration-webinar
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
Kubernetes & AI - Beauty and the Beast !?! @KCD Istanbul 2024Tobias Schneck
As AI technology is pushing into IT I was wondering myself, as an “infrastructure container kubernetes guy”, how get this fancy AI technology get managed from an infrastructure operational view? Is it possible to apply our lovely cloud native principals as well? What benefit’s both technologies could bring to each other?
Let me take this questions and provide you a short journey through existing deployment models and use cases for AI software. On practical examples, we discuss what cloud/on-premise strategy we may need for applying it to our own infrastructure to get it to work from an enterprise perspective. I want to give an overview about infrastructure requirements and technologies, what could be beneficial or limiting your AI use cases in an enterprise environment. An interactive Demo will give you some insides, what approaches I got already working for real.
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
3. Albemarle Corporation
2011 Net Sales Distribution - $2.9 billion
• Global provider of value
Fine added technical solutions
Chemistry
25%
• Comprised of three business
Catalysts
38%
segments with balanced
product portfolios
• Proprietary technology and
service-driven business model
• Fundamentally strong margin
and cash flow businesses
Polymer
Solutions Fine Chemistry
37% Services
Go to: www.albemarle.com
3
4. We Offer
• US-based leading cGMP and custom manufacturing production
capabilities
• Full project support (Technical, Regulatory, HSE, Information
Management, Logistics)
• Extensive process development and scale-up capabilities
• Expertise in the development of complex syntheses
• Long Term Relationship / Production Partner
4
5. We Have
• Excellent safety record (top 10% of ACC)
• Innovative technical staff that says YES!
• FDA registered facilities with no 483s in last inspections
• ISO certified custom manufacturing facilities
• State-of-the-art analytical support
• Raw material sourcing assets in China
5
6. We Have – Manufacturing Capability
• Five Commercial Scale Multipurpose Plants
• South Haven, MI (cGMP)
• Orangeburg, SC (including cGMP)
• Tyrone, PA
• Pasadena, TX
• Baton Rouge, LA
6
7. We Have – Manufacturing Capability
• cGMP capability - kilo, pilot and commercial
• 25 L to 16,000 gal Reactors of all MOCs
• Distillation and Wiped Film Evaporators
• Most types of solids handling
• Full Utilities
• Cryogenic to hot oil
• Pressures to 1000 PSI
• Short lead time for Environmental Permits
7
8. We Have – Development Capability
Full Scale
Lab
Kilo Lab Pilot Plant Commercial
Synthesis
Plant
Baton Rouge, LA Baton Rouge, LA Baton Rouge, LA Baton Rouge, LA
South Haven, MI South Haven, MI South Haven, MI South Haven, MI
Tyrone, PA LLN, Belgium Tyrone, PA Tyrone , PA
LLN, Belgium Orangeburg, SC
Pasadena, TX
Customer Driven
8
9. Albemarle Continuous Capability
• Over 40 years of Experience
• World Scale Plants (100’s to >10,000’s TPY)
• Existing processes at Multiple Plants
• Long Term Supply
• Proven Record with Recent Successes
9
10. Ag Chemical
• Long Term Relationship
• Expanding as Customer Grows
• Started <500 TPY
• Debottlenecked existing asset to > 1500 TPY
• Further capacity increase with new asset
• Process Includes
• Hazardous Chemicals
10
13. Pyrophorics
• Multiple Products
• Extremely Exothermic
• Adiabatic Temperature Rise > 2000 °C
• Unique Technical Solutions
• Long Term Supplier
13
14. Custom Lubricant Production
• Albemarle selected as Scale up Partner
• Commercial Plant Operational in 21 months
• 15,000 TPY established in first month
• Scale up from Lab Directly to Commercial
• No Pilot Plant
14
15. Bench Scale Equipment
• We have a Modular Multipurpose Apparatus
• Multiple Reactor Configurations
• Currently up to 3 different feed streams
• CSTR (single or series)
• Tubular Fixedbed
• Tubular Plug Flow
15
16. Bench Scale Equipment
• Temperature range
• –100 to 200 C with circulators
• higher with electric heating
• Pressure range
• Vacuum to 1000 PSI
• >1000 PSI in High Pressure Lab
• Feed rates
• 1 g/min to 100 g/min
16
21. Multipurpose Continuous Assets
• Existing Idle Equipment with World Scale Logistics
Support (rail and ship)
• Distillation Columns (100 PSI, 300 C)
• Continuous Hydrogenation Columns (500 PSI)
• High Pressure Reactors(1000 PSI, 300 C)
21
22. Why Choose Albemarle?
• Successfully Partner with both Small and Large
Companies
• Leading cGMP and Custom Manufacturing Facilities
• Competency in the Development of Complex Syntheses
• Extensive Process Development and Scale-up Capabilities
22
23. Why Choose Albemarle?
• Excellent Safety and Regulatory Record
• Demonstrated Consistent Success
• Large Scale Equipment Available
• Long Term Partner
23
24. Find out how Albemarle
says YES!
to your project.
Americas Europe, Middle East, Africa
• Fine Chemistry Services • EMA Fine Chemistry Services
• Tel: +1 225 388 7402 • Tel: +32 10 48 1711
• ALBSales@albemarle.com • EMASales@albemarle.com
Web: www.Albemarle.com
24