New Release: The Digital CMC™ Train Has Arrived

In Season 5 of the QbDVision Software Release Series, we introduced you to an expansion of a number of our newest feature sets, such as QTPP Management, Multiple Process Definitions, and more streamlined Data Management. 

With the release of Season 6, you can put on your dancing shoes as we continue to expand the feature sets to streamline your key workflows and advance the theme of Digital CMC within your organization.

Episode 1: Bringing Data Together With Integrity

Did you know that pharma/biotech companies only use about 4% of their data on average? Yes, it’s true, but probably not surprising to many of you with the prevalence of information silos in many organizations.

In our last release cycle, we featured the new changes to our Data Management module to simplify how your raw material and manufacturing data can be logged and tracked in QbDVision. Key new features include:

QbDVision's Latest Software Updates for CMC
  • New Import Workflow – Getting your batch and raw material data into QbDVision is now easier with new import workflows accessible right from the batch or raw material record created to hold this data.
  • Template Generation – Need a template to get your data imported, access the template generation feature directly from the batch or raw material record as well.
  • Visualization of Imported Data – We have further simplified visualization and tracking of these data by creating lists showing which data is from DS/DP batches and which is CoA data categorized by associated material.
  • Data Integrity – We have always focused on ensuring that our data workflows conform to the best practices of data integrity by design. For any set of data imported into QbDVision, supporting documents such as original batch records can be attached along with the imported data templates to ensure full traceability back to the source data.

Episode 2: Using Your Data, Finally!

So, you have all of this great data coming together in one software platform.  Now what?  Data analytics is all the rage these days.  But, we think that Information Analytics is a lot more powerful. What is Information Analytics? Well, Information = Data + Context and QbDVision brings these two together to facilitate information management.  Maybe the reason that data utilization is so poor is because it lacks context. QbDVision allows you to go one step further and capture the evolution of the information over time so that it becomes institutional knowledge.  Whoa!

  • Manufacturing Analytics – We have always brought context to data within the QbDVision platform and Flamenco has refined this even further. Now you can select specific batches of data on which to run your analyses. Want to see how one subset of batches is performing relative to another for a particular attribute or variable? Now you can do that easily in QbDVision and use that information to adjust the Occurrence risk for the attribute or parameter of interest.
  • Raw Material Analytics – QbDVision gives you the ability to capture raw material attribute data directly from CoAs. As you log data from more and more vendor lots, data from each new lot can be compared against previous lots to flag you if something seems amiss.

Start using Information Analytics so you can evaluate process performance and make intelligent assessments about process risk and characterization within the same environment.

Episode 3: Prime Time for Process Management

One of QbDVision’s key value propositions has always been the management of the evolution of your manufacturing process over the development lifecycle.  In this release, we have added two key feature sets that deepen this capability.

QbDVision's Latest Software Updates for CMC
  • Process Steps – Process management in QbDVision has centered around the definition of Unit Operations to categorize groups of activities. Our users have been asking for the ability to go more granular with the definition of Process Steps within each Unit Operation and now they can. Breakup each Unit Operation into as many Steps as you want.
  • Global vs. Local – Now with the additional layer of Process Steps, materials and process components and their associated attributes, parameters, in-process controls, and quality attributes can be defined globally at the Unit Operation level or locally at the Step level.
  • Keeping It Simple – Say you are baking a cake and you know that oven temperature is important but you don’t know what oven you are going to use? This happens all the time in pharma/biotech manufacturing. QbDVision allows you to define process parameters for Unit Operations and Process Steps without having to define the tangible asset of production associated with the process parameter.
  • Multiple Process Imports – With the ability to define multiple manufacturing processes for each product came the need to import information into each process separately. QbDVision now supports the import of both structural process information and process data into the desired process.

This just keeps getting better!

Episode 4: Audience Favorites

We are big believers in making sure our customers are happy and there is no better way to do that than to show them we are listening.  You can always make a feature request through our customer support portal and we wanted to highlight some of the changes to the QbDVision platform that were requested by our loyal users.

  • Archiving Without Approval – We understand the critical importance of data integrity which is why the archiving of information is a key functionality. In the past, archiving a record required approval by another party in the organization. For records that are approved via electronic routing, this is still the case. But, we all make mistakes, and records still in a Draft state can now be archived without another users’ approval.
  • Failure Modes for Material Attributes – When we designed QbDVision, we included a Failure Modes field for our Process Parameter data type. We knew this would be helpful when automatically generating FMEA reports in the future (yes, there is a better and more compliant option than manually creating and updating FMEA spreadsheets). Our users loved this feature so much, they wanted us to add the Failure Modes field to the Material Attribute data type as well. So we did! In the next release, we’ll add Material Attributes to the FMEA too!
  • Retraining Request – QbDVision also integrates many elements of eQMS such as document management, training management and supplier and risk management. There are times when an employee needs to retrain on a document for which they previously completed training. In this release, we have added the capability to easily request and track the re-training of an employee on a controlled document.

The ramifications for simplifying tech transfer are HUGE! Define all the elements of your process at one site/scale (requirements, variables, materials, equipment, etc.) and then quickly copy and modify for another site/scale. With the click of a button, you will generate future reports comparing the differences and completing in-line risk assessments on these differences. Wow! The process “neighborhood” is starting to look pretty good!

Season Finale: Enabling Digital Tech Transfer

The features highlighted in the previous episodes have an impact beyond their specific functionalities.  In other words, there is a method to our madness.  All of the new features of Flamenco come together to enable a new workflow with significant benefits – digital tech transfer.  Many of you in the industry are familiar with the challenges and frustrations of trying to execute tech transfer in compressed timeframes.  The document-centric approach to transfer information from sending sites to receiving sites is still heavily used but obviously antiquated in today’s digital world.  The structured data framework which is the foundation of the QbDVision platform is a fit-for-purpose architecture for digital tech transfer.  QbDVision is now the first software solution built as a fit-for-purpose solution specifically for the tech transfer needs of the pharma/biotech industry. 

QbDVision's Latest Software Updates for CMC and tech transfer
Key features of this solution include:
  • Digital Initiation – Initiate the tech transfer process by instantly copying the sending site process into receiving site process. Now you have two processes where each element of the sending and receiving site processes are linked together.
  • Process Editing – Modify the receiving site process to record different equipment, process parameters, acceptance criteria, etc.
  • Real-Time Gap Assessment – With two highly structured and linked processes managed within the same environment, automatically generate interactive gap assessment reports. Since your processes may continue to change and evolve, the gap assessment can evolve in real-time as well.
  • Real-Time Risk Assessment – With the gaps identified between the sending and receiving site, perform your risk assessments for each gap within the same workflow in QbDVision and record the next steps to further characterize the gaps and mitigate the risks.
  • Track Supporting Documentation – The ability to attach links and upload documents to any record type is a key feature of QbDVision and this feature displays prominently in the digital tech transfer workflow where large volumes of information are being managed and rapid access to supporting documentation is critical.

This is just the beginning of the digital tech transfer revolution.  The power of this approach will become even more evident as we build more automation into these workflows.  Stay tuned! 

If you are new to QbDVision and interested in trying out our solution, it’s available for a free 30-day trial, or reach out to learn more about exploring the platform’s expanded capabilities.

Diana Bowley

Associate Director, Data & Digital Strategy, AbbVie

Diana is the Associate Director, Data & Digital Strategy in S&T-Biologics Development and Launch leading the organization’s Digital Transformation since October 2021. She joined AbbVie in 2012 in the R&D-Discovery Biologics group focused on antibody and multi-specific protein screening and engineering, leading multiple programs to the cell line development stage. In 2017 she joined Information Research and led a team of IT professionals who supported AbbVie’s Discovery Scientists in Biotherapeutics, Chemistry, Immunology and Neuroscience. She has a PhD in Molecular Biology from The Scripps Research Institute and Bachelor of Science in Chemistry from The University of Northern Iowa.

Robert Dimitri, M.S., M.B.A.

Director Digital Quality Systems, Thermo Fisher Scientific

Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.

Devendra Deshmukh

Global Head, Digital Science Business Operations, Thermo Fisher Scientific

Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.

Grant Henderson

Sr. Dir. Manufacturing Science and Technology, VernalBio

Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.

Ryan Nielsen

Life Sciences Global Sales Director, Rockwell Automation

Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.

Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

Michael Stapleton

Board Director, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

Daniel R. Matlis

Founder and President, Axendia

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Joschka Buyel

Senior MSAT Scientist at Viralgen, Process and Knowledge Management Scientist at Bayer AG

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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