Category Archives: Latest

28May/21

AI-Assisted Automated Visual Inspection: An Amgen Success Story

Latest, Technology, Webinar, ,

By: Sandra K. Rodriguez, Senior Industry Analyst

The team at Amgen’s Juncos, Puerto Rico facility successfully implemented and validated the first AI-enabled visual inspection system in a production line. Hear directly from Amgen’s Jorge Delgado, Process Development Scientific Director and Manuel Soto, Senior Process Development Scientist.

We discuss the differences between AI, Machine Learning and Deep Learning, as well as demonstrating proof of concept and implementing the technology in a GMP environment.

Hear the incredible benefits achieved and much more in this “Straight from the Source” webinar.

20May/21

Reinventing the Value Network with the Factory of the Future

Latest, Research, Technology, , ,

The factory of the future goes beyond the traditional factory walls

By: Sandra K. Rodriguez, Senior Industry Analyst

The need for organizational visibility, control, and resilience has never been greater for the life sciences industry. Executives at forward-thinking companies are addressing the need to solve both present and future challenges. The increasing complexity of designing, sourcing, and manufacturing high-quality medical products under stringent regulations requires a digital factory that supports closed loop manufacturing across-the-product lifecycle. In short, a sustainable factory of the future is needed now.

The factory of the future goes beyond traditional factory walls; it requires digital transformation across the entire medical product value network. Axendia research indicates that 76 percent of digital transformation initiatives are being accelerated by “black swan” events. Digital transformation is a journey, not a project. Life science organizations that have embarked on this journey are modernizing manufacturing and reinventing their value networks.

Building the Factory of The Future, Today

Delivering high-quality, next-generation life-science products is not easy. Stakeholders expect high-quality, complex products manufactured sustainably under stringent regulations. The factory of the future supports closed loop manufacturing and workforce optimization by connecting the following technologies across the total product lifecycle:

  • Product Lifecycle Management
  • Enterprise Resource Planning
  • Manufacturing Operations Management (MOM)
  • Advanced Planning and Scheduling (APS)
  • Modeling and Simulation

Read the entire article in Medical Product Outsourcing

Register to receive your complimentary copy of our Voice of the Customer eBook, presented by Dassault Systèmes: The Life-Science Factory of the Future

Webinar available on-demand: Building the Factory of the Future, Today

14May/21

FDA Guidance on ICH Q12 Will Accelerate BioPharma PLM Adoption

Business, Latest, Quality, Regulatory, Technology

As Bio-Pharmaceutical companies look for opportunities to accelerate innovation cycles, the management of products across the complete lifecycle to support continuous improvement is a strategic imperative.  To fast-track innovation, companies need to be open to new ideas and have awareness of new and emerging systems and technologies. 

This week, FDA issued guidance supporting the use of ICH Q12 to encourage the use of Product Lifecycle Management across the Pharmaceutical.

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13May/21

Driving Digital Transformation in a Connected Eco-System

Business, Cloud, Latest, Quality, Regulatory, Technology, Webinar

Life-Science companies of all sizes are digitally transforming to improve quality, from raw material to patient, while achieving resilience, effectiveness & efficiency.

Hear from Edward Armstrong, Director QA at Mustang Bio, Beth Hayes, VP, BioPharma Strategy at Salesforce, Prashanth Rajendran, CEO at ComplianceQuest and Daniel R. Matlis, President at Axendia in this panel discussion

Take a sneak peak of our candid discussion in this video clip:

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30Apr/21

Infinite Opportunities from Infinite Data in Life-Sciences

Briefing Note, Business, Cloud, IoT, Latest, Quality, Technology

Siemens Announcements at the Hannover Messe 2021 – Event Brief

By Eric M. Luyer – Industry Research Analyst, Axendia Inc.

In these difficult “Corona” times the buzz word is “virtual”. Everything is virtual: meetings, webinars, education and conferences. A major yearly event is the Hannover Messe, Germany.  The event is a showcase and catalyst for the future of industrial transformation …and for 2021 it was virtual.

I had the opportunity to cover the first digital edition of the Hannover Messe from 12-16 April 2021.  According to Dr. Jochen Köckler, CEO of Deutsche Mess AG:  “The Hannover Messe 2021 Digital Edition demonstrates the innovative power of mechanical and electrical engineering and IT companies. At the same time, it showed that the tradeshow of the future is hybrid.”  And mentioned by the event organizers, 90,000 attendees generated more than 650,000 exhibitor and product searches during the five live trade show days.

This event is a showcase for all industries that are part of the industrial evolution.  It highlighted digital transformation processes necessary to meet requirements of sustainability and climate-neutral production, mobility of tomorrow and intelligent production and logistics technologies.  

This Event Brief reviews some of the exciting developments presented by Siemens A.G. during this virtual conference and how they might impact Life Sciences companies’ complex requirements now and in the future.

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