New Release: Digital CMC™ – A New Genre of Software

Grunge Software Release

In Season 6 of the QbDVision Software Release Series, we introduced you to ways of streamlining your key workflows and advancing the theme of Digital CMC™ within your organization.

With the release of Season 7, we see the growing desire to deploy digital technologies in the search for CMC Nirvana. This season, it’s time for more profound character development as we continue to build up the show’s stars.

Episode 1: Smells Like Tech Transfer Spirit

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, we introduced the Digital Tech Transfer capability for the first time, leveraging our structured framework to simplify this workflow. Picking up where we left off last season, tech transfer is at the forefront of this release.

Based on continuous usage and feedback across our customer base, we continued to expand our capabilities to include:

Comparison Customization. The comparison module now lets you customize which fields are tracked for changes. It goes even further to allow different comparison schemes for different variable types. 

Better than Excel. We’ve added new support for sorting and filtering so you can customize your tech transfer views and see what matters to you.

Shareable views. Once you have sorted and filtered your table to focus on the information that matters, share the specific URL with coworkers so they can see the exact same view.

Smart exports. Export what you see on the screen to take it with you, including your filters and sorting.

Teaser: In season 8, we will expand this report customization capability to many other parts of the software. Stay tuned.

Episode 2: Come as You Are, But Go Faster

As with any excellent TV Series in its 7th session, our not so front-and-center but critical characters must get TV time. This episode is all about speed.

Throughout our series, we’ve added hundreds if not thousands of features to our platform. Our users are finding newer and more imaginative ways to use the platform to rapidly digitize their workflows and information. We are excited by the many great ideas our customers share about making QbDVision even more powerful.

That said, now and then, we need to spend the effort to make the platform snappier. After all, one of our primary goals is to save our users time, and thus it’s crucial to make our application both powerful and fast.

We threw the book at performance, achieving gains of up to 70% in load times of specific pages and a 25% gain across the board.

Our improvements include:

  • Introduction of progressive page loading
  • Additional provisioned hardware (CPU & Memory) for physical performance gains
  • Optimized our page loading strategy for fewer network calls
  • Optimized database connection performance

The first improvement, progressive page loading, is where users will see the most prominent benefit. When most pages or reports in the application load, we’re pulling together all sorts of connections about a particular record, looking up – information, risk, related batches, related records, historical updates, etc.  With progress page loading, users can start engaging with the application once the first bit of information is ready. Previously, we waited until all that information was downloaded to your browser, causing some users to have to wait. Each page is ready in a snap, and users can continue using the application while their other data loads. 

There’s, of course, more to this story in future episodes.

Episode 3: Atomic Number 3

In the last season, we introduced Steps into our process model. Steps have been highly adopted as a way to bring more organization to a unit operation. Whether our users call them a “step,” a “phase,” or a “process action,” the feature has been met with considerable fanfare. 

We have upgraded our setup process to allow users to import steps during creation and  when updating their values, making it easier for new projects to get off the ground using steps. 

Now users can:

  • Create steps under unit operations via a separate Excel upload
  • Assign process components, materials, process parameters, and material attributes to a step via the upload process.

QbDVision's Latest Software Updates for CMC

Episode 4: Lounge Act

Building on the last episode, we’ve also upped our game with additional reporting and visualizations for steps.

Remember the joy of generating a Process Flow Map with the click of a button? Now, this map breaks out the linear input to output mapping by steps as well as unit operations.  The Risk Map provides the all-important, nonlinear traceability view from each input to each output. Now, the Risk Map will automatically segregate variables within a unit operation by steps providing more valuable information. 

Finally, take steps into account during tech transfer evaluation as well. Our tech transfer reporting is upgraded to work with the new Step functionality making scale-up and process transfer even quicker. Whether you’re visualizing steps or comparing step differences, it’s now faster and easier for you.

Season Finale: Endless, Nameless

Going further with character development, in this episode, we explored our process analytics module in detail. While we didn’t add any front-end charts and graphs, we overhauled our statistical formulas, chart selection, and error handling for various data scenarios. 

Changes include:

  • A new combined control chart for continuous data intelligently selects the appropriate control chart set based on the underlying data.
  • Updated statistical formulas and constants to better match the needs of pharma and biotechs.
  • Smarter selection of charts based on sample size.
  • Showing sample sizes for your batch data right on the reports for quick reference.

If you are new to QbDVision and interested in trying out our solution, 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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