Three Ways Smart Content Authoring Accelerates CMC Workflows

For drug developers, there’s a growing crisis in some of the most critical CMC workflows.

If you work in CMC, there’s a familiar and confounding question you’ve probably asked a few times recently: “Where is everything??” 

CMC programs in general are notorious for fragmented information resources – scattered document troves, siloed historical knowledge, and vast volumes of unstructured data. CMC workflows are no exception: searching for critical results, analyses, or datasets can feel a bit like stepping into an early draft of Inception. Except the impossibly complex dream levels are SharePoints, OneDrives, file storage facilities, and Teams threads.

And now, with exabytes of new data flooding into the industry every year, that long-standing challenge has become something more – a full-blown crisis of tedious data extraction, exhausting consolidation tasks, and project timelines dragged out by laborious reporting, analysis, and compliance tasks. It’s quite the nightmare for many CMC experts and their workflows, one perpetuated by the industry’s reliance on document-centric processes and unstructured knowledge.

But are CMC programs stuck in that nightmare forever? As one legendary “extractor” famously put it, “You mustn’t be afraid to dream a little bigger, darling” – which is exactly what we did with an exciting new addition of the QbDVision platform.

Let me introduce you to Smart Content Authoring and three ways it can turn convoluted, time-consuming CMC tasks into intuitive, modern, data-driven workflows.

Your key to accelerated CMC processes and outputs

Like all QbDVision modules and tools, our approach to creating usable online documents is built on a one-of-a-kind foundation: a structured knowledge and information framework that enables you to harness your CMC data in unprecedented ways. QbDVision itself is more than a SaaS solution for drug developers: it’s a powerful platform that turns structured datasets, data transformation technologies, and individual point solutions into a transparent, integrated knowledge base that enables workflow automation, drives operational efficiency, and enhances lifecycle management.

Here’s a quick look at how Smart Content Authoring through a tool like Doc Builder leverages this unified knowledge base to deliver effective outputs:

Like all QbDVision modules and tools, our approach to creating usable online documents is built on a one-of-a-kind foundation: a structured knowledge and information framework that enables you to harness your CMC data in unprecedented ways.

The secret to these capabilities: the “digital fabric” of CMC data that QbDVision weaves from the millions of data points and volumes of valuable content scattered amongst various programs and people. QbDVision frees this information from dead-end documents, servers, notebooks, and inboxes, and translates it into discrete data objects – individual units of data that can be linked into digital threads and woven into a holistic, comprehensive, application ready-layer of CMC data for the whole organization. 

Doc Builder is one of the most powerful of those applications that we’ve released so far. In just a few months, it has already made a quantifiable impact on customers’ CMC-related productivity, and just as quickly become a user favorite. 

Why? Well, to answer that, ask yourself a different question: how long do you currently spend each day on manually assembling reports or documents to support submissions? 

That shudder tells me all I need to know.

Use case 1: Unifying CMC knowledge

Perhaps the biggest challenge that QbDVision solves is the most fundamental: transforming scattered, siloed, disconnected CMC data resources into one connected, fully integrated information ecosystem. That fully unified system provides an ideal data architecture for specialized tools and applications, giving them the power to automate, accelerate, and de-risk critical steps and tasks across the development cycle.

Here’s what that ecosystem looks like once it’s unified in QbDVision. Every one of these “digital threads” – and the data points each one connects – can be tied directly to a report or submission by a Smart Content Authoring tool.

The beauty of this structure: It stores, links, and builds on work you’ve already done. Once you’ve created it, you never have to re-do it, search for it, or piece it back together – ever. With everything right there, ready to access, and ready to integrate, you can create, review, and finalize your CMC outputs all in one validated environment. No file-chasing, email scouring, or SharePoint diving required. 

So what could that simplicity look like day-to-day in your CMC program? Let’s ask someone who’s currently doing it the hard way – and see what happens when those time-consuming tasks are automated away.

Use case 2: Automating compliance & reporting

If you’re like most scientists, engineers, analysts, or other experts who support CMC initiatives, slogging through another manually generated report probably makes you wonder if it’s really worse to get a root canal. Like all too many CMC workflows, compliance-related reporting can be a time suck big enough to feel like it should have its own event horizon.  

Powering that vortex is the same age-old culprit: the sometimes hundreds of documents, files, and fragmented datasets that often need to be searched, consolidated, and stitched for every report…every time it needs to be produced.

But with digital document generation through QbDVision, a process that can sometimes take months can be completed in minutes. How? By tapping into all the scattered, siloed, fragmented data that has already been created in QbDVision – structured, linked, and ready to push into documents that regulatory agencies require. Once all of your documents, files, and datasets have been translated into searchable, linkable data objects, organizing those objects in a template can be as simple as hitting “generate report.”

How powerful is that? Here’s another way to look at it: In today’s CMC ecosystem, whenever you need money for lunch you have to shake couch cushions, search drawers, check pockets, and look under the bed. WIth QbDVision you have a CMC bank account, flush with every asset you need and ready to tell you exactly what you need to know about your resources. And producing a templated document – whether it’s an IND, a BLA, or your own custom report – can be as simple as downloading a statement. 

In today’s CMC ecosystem, whenever you need money for lunch you have to shake couch cushions, search drawers, check pockets, and look under the bed. With QbDVision you have a CMC bank account.

A recent analysis by a QbDVision user showed the remarkable efficiency this tool can help organizations achieve. By automating their compliance workflows with a tool like Doc Builder, they reduced their overall reporting time by a remarkable 95% by eliminating duplicate work on development reports like FMEA. One key reporting task was even reduced from 3 weeks to just 6 hoursExcited to knock literally weeks of tedious manual reporting tasks out of your year? Wait till you see what Smart Content Authoring  can do for your teams.

Use case 3: Streamlining tech transfers

There are few topics that can spike a drug developer’s diastolic blood pressure like tech transfers (looking at you, Inflation Reduction Act). They’re expensive. They’re time- and resource-intensive. They can have uncomfortable margins for error. McKinsey recently reported that tech transfers alone take an average of 18 months – a painfully long time on the final lap to commercial production. 

Many different factors contribute to these notoriously long runways, but knowledge management is at the heart of the challenge. Document-based information and siloed process and operational knowledge simply take a long time to gather, consolidate, package, and re-implement in a different manufacturing environment.

Today, a typical tech transfer often kicks off with a scramble to capture all the necessary data, methods, processes, and parameters, and then consolidate, review, and approve them in yet another new stack of transfer-related documents. With QbDVision, all that information and knowledge is already captured in QbDVision during the development process – and plugged straight into Doc Builder. Mapping any of that data to new site and/or MES processes is as simple as generating a custom report and sending the recipient a login.

Need that method? Log in and grab it. Want to cross-compare materials, parameters, and specifications at each site? Click. Need to make a recipient aware of an updated attribute? Push.

Equipped with these tools, both sending and receiving sites can realize a stack of benefits across the tech transfer process:

Need that method? Log in and grab it. Want to cross-compare materials, parameters, and specifications at each site? Click. Need to make a recipient aware of an updated attribute? Push. It all happens in real time, with full visibility for both sides, with a fully compliant change log and audit trail. 

So what does it look like for a user when they lift this huge burden from their MSAT teams? For our MENA customer, it looks like tech transfers that happen 3X faster than their typical cycle time. With QbDVision and Smart Content Authoring, they could virtually eliminate the time-consuming process of recalculating their risks at different scales and in different environments. Instead, they could simply set up a custom report in Doc Builder, change parameters as needed, and update the outputs – then share them with any site in their network with one click.

This is what the future of Digital CMC looks like. Except you can start using it today.

There’s a very good chance someone from your CMC department has asked, “shouldn’t we be able to automate this by now?” Well guess what: you can. The best part about this powerful new tool (I mean, aside from the fact that it can save you months of time and significantly improve data integrity) is that it’s ready and waiting to be used now. 

In fact, this approach to content authoring is already changing the game from numerous CMC programs across the industry, where it’s helping users accelerate the transition from document-dependent processes to digital-first processes with streamlined document outputs. The three use cases I’ve offered here are first of many to come – but also the perfect showcase for what’s possible with a unified hub for all your CMC data. 

Centralized knowledge, automated reporting, and streamlined tech transfers are just the beginning. Stick around to see what’s next!

GET IN TOUCH

Ready to take QbDVision for a spin?

We’d love to show you how Smart Content Authoring can help save you time, headaches, and re-work. Reach out to our team of Digital CMC experts to schedule a demo.

Vijay Raju

Vice President, CMC Management, Flagship Pioneering

Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.

Greg Troiano

Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence, Sanofi

Greg serves as Head of cGMP Strategic Supply and Operations at the mRNA Center of Excellence at Sanofi, where he is responsible for all aspects of clinical production and raw material supply chain. He joined Sanofi via acquisition of Translate Bio, where he was Chief Manufacturing Officer and responsible for Technical Operations. Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.

Pat Sacco

Senior Vice President Manufacturing, Quality, and Operations, SalioGen

Pat is a Biotechnology technical operations executive with 30+ years of experience leading and managing technical operations functions at numerous innovative companies in the biotech and life sciences industries. He has a passion for advancing and implementing best practices in pharmaceutical manufacturing.

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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