In this workshop we will present six brief talks on how digital technologies such as AI, Cloud, modular design, real-time monitoring, advanced data analytics, and remote monitoring can maximize process technology efficiencies and advance a digital transformation.
Regulatory considerations of software solutions within biopharma manufacturing will also be discussed.
Each talk will put forward real-world applications and use cases and will be followed by a live Q&A session with the speakers.
*Below times are BST (UTC+1)
Where are you on the Digital Maturity Roadmap?
with Ranjeet Patil
Topic 1: Frontiers in Digital Bioprocessing
Presented by: René Reinbigler and Lukasz Paciorkowski
Digital technologies have had a profound impact on all industrial sectors – Life Science is no exception. Addressing the growing market demand for new therapeutics and vaccines, reducing cost and time to market, and managing regulatory expectations requires a paradigm shift in how biotech companies operate.
Digital technology is a necessary building block for next generation bioprocessing and the Facility of the Future. Technologies like artificial intelligence (AI), machine learning (ML), Cloud, modular design, and automation are great enablers, but true transformation requires going beyond implementing new technology.
At Merck, we firmly believe that the convergence of process technologies and digital technologies is the key to success. This synergy will enable multiple frontiers of Bioprocessing 4.0.
In this talk we will dive into 2 digital technologies: modular design and Cloud. Both areas have the potential to accelerate the critical aspects of the Facility of the Future through modularity, increased regulatory compliance, integrated user experience, efficiency of operations and finally, quality of the product. We believe that investment in these technologies today will benefit our customers in their digital transformation through new business models, collaborative organizational structures, and agility to respond to customer’ needs.
Topic 2: Process Analytical Technology (PAT) Using Next Generation Raman for Real-Time Bioprocess Monitoring
Presented by: Hemant Garg and Kevin Grollier
Cell culture processes are complex and highly variable in nature and yet only a handful of key parameters such as temperature, pH, and dissolved oxygen (DO) are typically controlled in real time in upstream development.
While the measurement and control of these parameters is necessary for successful bioprocess monitoring, they do not provide a direct indication of the culture’s content itself, but only rough assumptions on the culture’s true state and limited process and cell growth understanding.
Critical process parameters (CPP) such as glucose, lactate, or ammonium and key performance indicators (KPI) such as total cell density (TCD) and viable cell density (VCD) provide a direct indication of the culture’s content and state but are generally measured off-line and therefore, not in real time.
Similarly, mammalian cell culture feeding strategies lack real-time measurement and rely on daily manual sampling which increases the risk of contamination and batch failures.
In this presentation, we will explore how to implement in-line and real-time monitoring of upstream cell cultures using Raman technology. We will discuss how in-line Raman can improve processes, save time, and reduce the risk of contamination and batch failure. We will also present a use case on how to implement a nutrient control loop strategy, a first step towards automation.
Topic 3: Smart Bioprocess Data Utilization for Advanced Analytics and Near Real-time Monitoring
with Data Analytics Tools Purpose-built for Bioprocessing
Presented by: Nishant Gupta
Throughout the biopharmaceutical manufacturing life cycle from process development to commercial production, end–to–end knowledge management is required for QbD, PAT, and CPV initiatives. As the industry evolves towards Bioprocessing 4.0, the wide range of data generated is an important resource for process understanding and operational control. Systems and platforms which speed up data acquisition and its analysis for real-time monitoring and faster decision making are needed. In this talk, I will share my experience working with organizations as they adopt solutions for automated data acquisition, aggregation, visualizations, and statistical analysis.
Topic 4: Orchestration for Remote Access and Monitoring of Bioprocess Unit Operations:
Benefits, Considerations, and Use Cases
Presented by: Aniruddha Bose
If checking on the status of a process, collecting data, reporting, or managing user permissions and passwords requires being on the plant floor and logging into and using each system’s HMI –normally multiple systems – than process understanding and management is limited to the plant floor.
In this talk we will describe how orchestration software can provide remote visibility and access to plant unit operations and thereby improve process monitoring and visualization, improve data collection and data integrity, and reduce manual tasks and operating costs.
We will provide real-world orchestration use cases including centralized and consolidated user management, automated reporting across multiple systems, and improved technology transfer
Topic 5: Regulatory Guidance on GMP Software
Presented by: Sujatha Gopi
In this talk we will present regulatory requirements for software systems in a GMP environment. Topics covered will include:
• How software can facilitate 21 CFR Part 11 compliance
• Data integrity’s ALCOA+ characteristics and why in making data easily searchable, accurate, and difficult or impossible to alter software can support data integrity
• Improving continued process verification or ongoing process verification programs with automated monitoring of parameters against set limits
Topic 6: The Evolution of AI – Accessibility for Everyone – How Will Artificial Intelligence Help Biotech Scientists?
Presented by: Philippe Eberhard and Hemant Garg
Digital technology innovation is transforming the life science and biopharma industries. Data generated, captured, analyzed, and used in real time is the industry’s new asset. A key differentiator for companies is the extent to which they can generate insights and evidence from complex and multiple data sources. Data is a key element to increase bioprocessing product and process understanding.
The biomanufacturing industry is evolving from a standard batch processing paradigm to a more continuous operation supported by in-line sensors and process analytics to enable real-time product release. Data-driven continuous operations will help to significantly improve product quality, reduce production costs, and shorten the time to market.
Companies can tackle these technical challenges by leveraging data science including artificial intelligence (AI). To benefit from the promises of AI, manufacturers must learn how to maximize the utilization of the datasets already at their disposal and to identify, access, and integrate new data sources.
Considering the complexity of bioprocessing combined with the industry’s inherent “data siloes” we will focus on how companies might best use the power of smart data to leverage AI and drive additional insights.
with Ranjeet Patil
Senior Director, Head of Innovation Management for BioContiuum™ Platform
Heading a global team of engineers, scientists, and product leaders to execute the convergence of process technologies, software & automation, and analytics to deliver on the promise of Bioprocessing 4.0.
Ranjeet Patil heads a global team of bioprocessing experts for the Vaccine and Viral Therapy Segment. In his current role, he and his team provide consultative expertise to address process challenges and guide the development of innovative solutions. For the past 10 years, he has been working in various technical functions across both North America and Asia. His previous roles included: early-stage bioprocess development, virus clearance validation and process optimization and troubleshooting. Ranjeet is a Bioprocess Engineer and holds a post-graduate degree from Northeastern University in Boston.
Bioprocess Automation Consultant, Merck KGaA, Darmstadt, Germany
Aniruddha is a passionate marketer with over 14 years of experience in global biotechnology markets focusing on research, bioprocessing and biomanufacturing. At Biocon, he managed molecule screening and process development projects for mAbs. Later at GE Life Sciences (presently Cytiva), Aniruddha moved into Business development, Applications support and later into Product management. In his current role as Bioprocess Automation Consultant at Merck KGaA, Darmstadt, Germany, Aniruddha oversees the global market for software and automation products in the Bio4C™ Software Suite. He earned degrees in biotechnology from Bangalore University (B.S.) and Vellore Institute of Technology (M.S.) and a postgraduate degree in business management from Narsee Monjee Institute of Management Studies.
Bio4C™ ProcessPad Product Manager
Hemant Garg is on a digital mission to help the biopharmaceutical industry grow and evolve in a data-driven world. Trained as a business analytics engineer, he has 13 years’ professional experience working across multiple roles within biopharma manufacturing. Hemant’s expertise in complex industry research, long-term forecasting, data analytics and process modeling enable him to identify, create, and capitalize on unmet market needs. At Merck Life Science, Hemant leads the strategy and launch of digital and analytics products for biopharmaceutical customers.
PAT Implementation and Support Engineer
Kévin graduated from the Lyon Pharmaceutical Industry Institute (IPIL), with a master’s degree in pharmaceutical production specializing in biotechnology. This diploma was augmented by a training at the Management School of Lyon.
At Merck Life Science Kévin is a PAT Implementation and Support Engineer in charge of executing Raman projects, training, and providing technical support on hardware, software, and data analysis topics.
Before joining Merck, Kévin worked at Merial (now BIAH) as a QA validation engineer where he worked on various validation activities including cleaning, process, analytical methods, decontamination.
Lukasz is a digital practitioner focusing on Industry 4.0, IoT, Cloud, and digital strategy building. He combines his passion for technology with business and industrial insights to design the Facility of the Future for the biopharmaceutical sector. Lukasz’s background is in digital transformation projects, technology implementation programs, innovation and R&D initiatives. He gained his experience working at IBM, Accenture, and Merck. Lukasz is the founder of Architects for Business a company which focuses on delivering meaningful innovation across industrial sectors.
Associate Director – BioContinuum™ Platform
With of over 12 years’ experience in the life sciences industry, Nishant Gupta has held various roles in core manufacturing operations, MSAT, tech-transfers, and consulting. He has a strong background in process technologies and process data analytics and works with biopharma companies around the world to understand their current challenges and needs for digital maturity. He leads Merck’s commercial development and customer engagement efforts for the Bio4C™ Software Suite. Nishant holds a bachelor’s and master’s degree in Biochemical Engineering and Biotechnology from the Indian Institute of Technology, Delhi.
IT Architect at Merck KGaA, Darmstadt, Germany
With over 20 years’ experience, Philippe Eberhard is a Senior IT Innovation Manager in Software & Automation at Merck KGaA, Darmstadt, Germany. He worked in the highly regulated in vitro diagnostics at Johnson & Johnson. Philippe’s current role focuses on the supplier side of the biopharma industry finding innovative ways to solve business problems using the latest technologies. He has a passion for bringing user-centric solutions that solve the toughest technical and analytics challenges whilst maintaining the highest level of compliance to industry standards.
Software Regulatory Subject Matter Expert
Sujatha Gopi is a Software Regulatory Subject Matter Expert at MilliporeSigma supporting software and medical device portfolios. Prior to joining MilliporeSigma, she worked as senior verification and validation software engineer. Sujatha earned her bachelor’s and master’s degrees in computer science from Dr MGR Educational and Research Institute and University of Missouri.
Head of Digital Technologies
René Reinbigler is a Software Architect within the BioContinuum™ Platform. He has 30 years of experience in the biopharma industry designing upstream and downstream equipment and supporting customers around the world in setting up, qualifying and troubleshooting the production process of monoclonal antibodies. René is the co-author of 25+ patents in the area of bioprocessing and is currently working on innovative solutions which have the potential to transform how the bioprocess is being executed.