Track Process Evolution with Digital Process Management

As your team cycles through the development process, there is one constant: change underpinned by learning from each phase.

The acquisition of manufacturing knowledge and execution of activities isn’t always linear. Activities related to a scale-up process may go on in parallel to studies on a development scale process.

We’ve added some significant improvements to our process model to better support the agile workflows of all stages of R&D.

What’s changing

We’re introducing a few significant changes to our process model

  1. The ability to design and manage multiple processes inside one project
  2. Allowing process parameters and material attributes to be defined separately from their associated equipment and materials

Multiple Processes

QbDVision already supports multiple projects and, now, with multiple processes per project, we support a 3-D Process Development Profile.

QbDVision projects can now manage multiple processes within a single project. This change adds significant depth and flexibility to the management of process evolution for complex manufacturing processes.

  • Use Case 1: Track process evolution starting with early recipe management (ingredients, attributes, parameters) into site-specific and scale-specific processes including materials, process components, and equipment.
  • Use Case 2: Start your Upstream process and then add Downstream and Fill/Finish processes to track how they all impact final product quality.
  • Use Case 3: Manage input material preparation (e.g. buffer, media, etc.) as part of overall process management
  • Use Case 4: Manage alternative/derivative processes during process evaluation and characterization for optimization
  • Use Case 5: Compare performance across processes, scales and/or sites

New Process Record

To accomplish this change, we’ve added a new process record as the parent of your process. In this record, you can set properties such as usage, scale, supplier, description, etc. New and existing projects will now see the “default” process titled as such.

Each process has been designed to manage its own unique set of records. So, each process contains unique unit operations, parameters, etc. There are capabilities to copy existing processes, making it quick and easy to create derivations from your existing work. Additionally, the platform is now process-aware, so you can seamlessly choose the process you’re viewing when in a report, or even when making additions to your data uploads.

Variable Decoupling

Versions prior to this release would require the creation of a material or process component record before material attributes and process parameters could be defined. This restriction has now been removed. Going forward, material attributes and process parameters can be defined without a parent object. Decoupling of variables from their associated objects allows for the definition of early recipes where process scientists want to assess risk, evaluate and characterize the variables before considering the specific components and equipment that will be used to execute the process.

Our unassigned category includes the attributes and parameters that don’t yet have a known relationship to materials or components. These relationships can be created via links at any time once the related materials, components, or equipment are known.

Why is this happening?

The changes described here are in keeping with our philosophy of continuous improvement to further simplify tracking the evolution of complex manufacturing processes throughout the lifecycle. As more teams come on to the platform, we continue to focus on creating an information structure that is simultaneously flexible and comprehensive, and consistent with the concepts of ICH and other regulatory frameworks.

How do I use it?

A new process can be created from the process selector drop-down menu in process explorer.

Additionally, right-clicking on a process will give you a context menu with additional options for copying and archiving, amongst other options:

While in the reporting section, you’ll see a new menu option to change your process. The platform will remember your last choice and keep it sticky as you navigate around.

Finally, adding new process parameters and material attributes is as simple as it was before. Simply select the add button in your process tree.

Availability

Multiple processes support is available today in our standard and sandbox environments. Our validated product customers will see them in the Electronica release, expected in February of 2021.

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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