Entering a New Dimension with PAS-X

Körber Business Area Pharma Connext Software Summit 2022 Event Brief

Axendia’s Sr. Industry Analyst, Sandra K. Rodriguez, delivered the keynote address at Connext North America 2022 in Raleigh, NC.  One hundred attendees representing thirty companies attended Körber’s first in-person event in North America in two years.  A full program of customer success stories, regulatory updates, product demonstrations and workshops were on the agenda during October 4 – 5, 2022.

Keynote Recap

Digital transformation is still an imperative for life science companies.  According to Axendia’s latest market research report: The Needle is Moving – Digital Transformation in Life Sciences Manufacturing, 69% of organizations are either piloting, implementing technologies or have completed digital transformation.  Additionally, 50% of companies who are of the opinion that regulatory frameworks support digital transformation strategies are currently undergoing digital transformation in manufacturing.  In contrast, only 7% who are of the opinion that regulatory frameworks do not support digital transformation are current undergoing digital transformation.

To lessen the burden of implementing technology and automation solutions, the FDA released its long anticipated guidance document, Computer Software Assurance for Production and Quality System Software on September 13, 2022.  The guidance discusses specific risk considerations, acceptable testing methods, and efficient generation of objective evidence for production or quality system software.

Werum PAS-X Extended

As of 2022, Werum IT Solutions has officially been renamed to Körber Pharma Software. The Körber Business Area Pharma delivers integrated solutions spanning consultancy, inspection, handling, packaging machines and materials, track and trace, and industry leading software.

With the PAS-X Intelligence suite, the extended Werum PAS-X portfolio now contains data management and analytics, providing for expanded MES capabilities with specific solutions for pharma, biotech and cell & gene companies.  “With the release of PAS-X MES 3.3, we are leading the transformation of pharma manufacturing operations,” said Bonnie Bordeaux, President Software, Körber Business Area Pharma North America.  Additionally, with PAS-X MES 3.3, companies can choose how they want to run their MES – in their own data center, in the cloud or as PAS-X SaaS. 

Pictured left to right: Jens Woehlbier and Bonnie Bordeaux

Jens Woehlbier, CEO Software at Körber Business Area Pharma correctly pointed out what the industry wants: “Our clients need faster MES deployments and access to out-of-the-box functionality.  They want to minimize human intervention and errors while increasing data quality and integrity.” .

Körber Business Area Pharma has also expanded its PAS-X Savvy partner network and announced new partnerships with Sequence and Project Binder, which will allow customers to benefit from data analytics capabilities worldwide. “PAS-X Savvy is a data analytics platform that manages, visualizes and analyzes pharma and biotech data from different data sources, manufacturing sites and stages of the product lifecycle, and automates reporting,” explained Kevin Stembridge, VP of Product Management Software, Körber Business Area Pharma.

Customer Story

Lyell is a US-based, cell therapy biotech.  The company is pioneering novel T-cell reprogramming technologies designed to address major barriers to successful adoptive cell therapy (ACT) for solid tumors. Today, PAS-X MES as a Service is in operation at its GMP production site in Bothell, MA. The solution is fully managed by Körber in the cloud and has enabled digitalization, eliminated manual steps and human errors, sped time to market and boosted manufacturing efficiency and compliance. 

With its ERP already integrated, Lyell is planning for later system integrations using PAS-X standard connectors.  The goal is to drive release times down to get quality products out to patients as quickly as possible.  “It was extremely critical to start our digital journey from the beginning to avoid compliance gaps and the costly effort of switching from paper during the most critical time in our company’s lifecycle – going commercial,” said Joe Maguire, Head of GMP Automation and Data at Lyell.  

Ready2Run

Torsten Isenberg, VP, Global and Regional Business Consulting Software at Körber Business Area Pharma, introduced team members responsible for the company’s MES methodologies including project implementation, learning, MBR studio, validation, software lifecycle, upgrades and migration.  “Our Ready2Run methodology helps companies implement PAS-X MES as is, and out-of-the-box, in a rapid and smooth way,” said Isenberg.

Kristi Korson, Head of Training Academy Software at Körber Business Area Pharma, expressed that a 26% turnover rate in the life science industry today, coupled with the need for people to move around, is creating a perfect storm when it comes to learning needs. “Complexity is everywhere and we’re in the digital age – why should training be any different?” asked Korson.  She also noted that users are looking to take learning into their own hands.  The Pharma Academy now offers web-based training, instructor led training and end user training.  Web-based training is available on-demand and on any device.  To support various training methodologies, Körber is offering gamification and interactive learning tools, plus a live PAS-X environment and exercises users can complete.

Nelly Chankova, Head of Global Consulting Software at Körber Business Area Pharma, began with common questions when it comes to validation such as “How do we do risk-based testing? How can we leverage vendor testing? What’s the best way to make sure traceability works and of course, what are the costs? These are all challenges in validating MES,” said Chankova.  The validation services group helps clients understand the difference between a new implementation and changes to a validated system.  Chankova also suggested that when it comes to functional testing companies should ‘leverage and not test!’  Lastly, Chankova reminded the audience that in case of system changes a process risk assessment has to happen to determine if your process is impacted. If it is not, don’t change SOPs and conduct user acceptance testing.  With this approach companies can finish validation activities in weeks, not months.

Kaushal Popat, Principal Project Manager Software at Körber Business Area Pharma, indicated the magnitude of change from PAS-X MES 3.1 to 3.3 requires a migration, not upgrade. Typical migration challenges include what data to migrate and what data to retire. “We help companies understand the production impact on the migration.  Through our phased fast-track implementation methodology Read, Fit, Build and Run, we offer clients tailored approaches to support a successful migration strategy,” said Popat.

In Brief

Life science companies are continuing to become more cloud comfortable. With PAS-X MES 3.3, MES as a Service or MES in the cloud is now a reality.  Based on Axendia’s interactions with life science executives from companies of all sizes, there is a definite cloud-first approach within the small and medium-sized business market. This trend makes sense as companies would rather focus on their core business rather than building and supporting custom or homegrown solutions. 

After a full day of client success stories and what’s new with PAS-X MES 3.3, we headed to the Drive Shack in Raleigh to continue the conversations that will drive digital transformation in pharma and CGT manufacturing. I hadn’t swung a golf club in many years and would like to personally thank my teammates for their patience and words of encouragement: Pat Tucker, MES Program Steward at Merck; Corby Kassebaum, Business Process Owner of PAS-X at AstraZeneca, Sai Krishnan Vaidyanathan, Senior Business Analyst at AstraZeneca; and Andrew Jacon, Strategic Account Manager Software at Körber Business Area Pharma.

Pictured from left to right: Pat, Andrew, Sandra, Sai and Corby

Contact research@axendia.com to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.

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