Name: Intelligent Biomanufacturing Systems: From Design to Control in Industry 4.0
Start: 2026-11-05T14:30:00Z
End: 2026-11-05T14:32:00.000Z
Location: BrightTALK

BioPharma Webinars aims to keep its global audience abreast of all developments in the areas of Drug Development, Manufacturing, Quality Assurance, Outsourcing and Regulatory Affairs, with only the highest quality webinars, presented by the most respected people, working with companies in Pharmaceutical, Biopharmaceutical, Biologics and Biotech Industry.

AAV-based gene therapy samples are heterogeneous and can be composed of capsid monomer, aggregate, and fragment species. Tracking the relative abundance of these size-variant populations in the product and manufacturing process allows for greater control in delivering a consistent product to patients, and characterizing these species by size, shape, and composition provides a greater understanding of aggregation assay readouts. This study describes a framework for selecting fit-for-purpose aggregation assays based on assay context, including product release, in-process testing, characterization, and discovery/early-stage development, by carefully weighing assay parameters including specificity, precision, accuracy, software compliance, selectivity, sensitivity, turnaround time, throughput, platform compatibility, and sample requirements. This study also describes a reproducible forced-aggregation protocol for generating small, soluble capsid aggregate controls that can be used to assess assay performance across a wide variety of assays, including TEM, AUC, SEC, SEC-MALS, and FFF-MALS. Finally, this webinar summarizes results from a case study evaluating eight aggregation assays to empirically determine which assays are best suited for each assay context.

Aggregation Analysis in AAV: Selecting Fit-for-Purpose Assays

• Macro mass photometry (MMP) was used for the first time to analyze the mass and
size of lipid nanoparticles

• MMP revealed the effects of PEG-lipid concentration, mRNA encapsulation, and
antibody conjugation on LNP size and mass

• The study demonstrated MMP’s utility in monitoring LNPs under various stress
conditions

Characterization of Lipid Nanoparticles Using Macro Mass Photometry Insights into Size & Mass

The strategic necessity of data enablement has never been clearer; without a solid data footprint, organizations cannot enable advanced technologies like AI. Importantly, and encouragingly, the data enablement of people using effective skilling approaches is receiving significant industry energy and interest. This presentation specifically outlines work by the Life Sciences Advisory Board representatives at a 2026 Data Enablement workshop held at Fujifilm Biotechnologies, Holly Springs, NC, USA that had seven organizations represented and carefully discussed the impact, activities, and skilling journeys of those working as business data stewards.

This presentation will present the business data steward profile produced by the advisory board representatives and bring greater awareness to the work that leading organizations have been doing during 2026 to advance the skilling of their people who have either part time or full time responsibilities as data stewards.

Pharma Industry 4.0 Will be Advanced by the Data Enablement of People

Plasmid DNA is a fundamental starting material for cell and gene therapy products, where quality attributes, such as topology, directly impact production. DNA topology measures the distribution of DNA isoforms, including supercoiled, open circular, linear, and other isoforms. Common analytical methods for topology assessment include agarose gel electrophoresis (AGE), capillary electrophoresis with laser-induced fluorescence (CE-LIF), and anion exchange chromatography (AEX). Topology assessment remains challenging due to method-dependent bias, limited harmonization, and a lack of well-characterized reference materials.
The United States Pharmacopeia (USP) has developed plasmid DNA analytical reference materials to assist in the characterization of plasmid DNA. These reference materials range in size from 4.1 kb – 8.8 kb to align with the different plasmid sizes used during production. The plasmids were predominantly supercoiled but also contained other isoforms to capture capabilities of each analytical method. Herein, we will share data from a multi-laboratory study and highlight differences between the three techniques.
These reference materials provide a standardized tool for improving topology assessment, supporting method development, qualification, and cross-platform comparability. Combined with USP documentary standards, they help enable more consistent and reliable testing practices, advancing the overall quality and characterization of plasmid DNA used in therapeutic manufacturing.

Enhancing Plasmid DNA Quality Through Robust Topology Measurement

Endotoxin Testing of Pharmaceutical Products using Synthetic Reagents describes AstraZeneca’s approach to evaluating and adopting synthetic reagents for product endotoxin testing. As industry interest in alternative methods continues to grow, this presentation will explore the scientific, regulatory, and practical considerations involved in implementing synthetic reagents within a pharmaceutical development environment. The session will outline AstraZeneca’s journey toward adoption, including the drivers for evaluating synthetic reagent technologies and the steps taken to assess their suitability for pharmaceutical product testing. It will discuss current regulatory perspectives relating to the use of synthetic reagents and how these considerations influence validation strategies and implementation plans. The presentation will also describe the validation approach used to demonstrate method suitability, with attention to product-specific considerations, comparability, and data generation.

Endotoxin Testing of Pharmaceutical Products using Synthetic Reagents

Particulate contamination in parenteral drug delivery devices poses significant risks to patient safety, including embolism, phlebitis, and granuloma formation. Multiple regulatory standards establish requirements for particulate matter control across different device types and administration routes. ISO 11040 series address prefilled syringes for pharmaceutical use with specific requirements for container closure integrity, extractables and leachables, and particulate contamination limits aligned with pharmacopeial requirements. ISO 11608 series cover pen injectors and autoinjectors for self-administration with general requirements including particulate control during device operation, including design features to minimize particle generation from device components and during activation. ISO 8536-4 addresses infusion sets for single use with requirement for particles. This framework ensures comprehensive particulate control across various drug delivery platforms, protecting patient safety while maintaining product quality throughout the supply chain.

Particulate Control in Parenteral Drug Delivery Devices

Particulate matter control is a cornerstone of biologic drug product quality, yet the analytical methods used to characterize it are not without limitations. Light Obscuration (LO), the compendial standard under USP <788>, has been widely adopted across the industry; however, accumulating evidence suggests it may systematically underestimate proteinaceous particulate burden in complex biologics including monoclonal antibodies and insulin formulations and may lack the sensitivity needed to detect subtle manufacturing variability in protein therapeutics.

Flow Imaging (FI) has emerged as a powerful complementary technique, offering not only particle count data but also rich morphological information encompassing particle shape, size distribution, and compositional features that can be critical when characterizing heterogeneous particulate populations such as protein aggregates, silicone oil droplets, and morphologically diverse contaminants.

This webinar will provide a data-driven, case study-based comparison of Light Obscuration and Flow Imaging analytical performance in the context of biologics development and quality assessment. Attendees will gain practical insight into method selection considerations and the scientific rationale for deploying Flow Imaging alongside or as an alternative to Light Obscuration in specific biologic contexts, as well as the product quality implications of method choice including the risk of underdetection and its downstream regulatory and patient safety consequences. The session will also address validation strategy and acceptance criteria development for particulate matter testing in biologic drug products, with an emphasis on fit-for-purpose method design. Professionals working in analytical development, quality assurance, and regulatory affairs will find this webinar relevant, as it aims to share practical perspectives and considerations that may inform particulate matter characterization strategies in biologics programs.

Navigating Particulate Matter Analysis in Biologic Drug Products

This presentation explores the use of solid phase cytometry for in process bioburden, short shelf-life product and water testing. Solid phase cytometry is being looked at as the new frontier for pharmaceutical microbiology especially for cell and gene therapy. The presentation looks at the practicality, use and limit of detection of these methods in a GMP QC environment and determines what further work might be required. It focuses mainly on low bioburden and in process testing for small molecules. Other new technologies are discussed such as solid phase real time imaging and real time imaging for pharmaceutical development.

Assessing the Use of Solid-Phase Cytometry for Rapid Bioburden Testing

Process Analytical Technology (PAT) has evolved significantly since the FDA’s 2004 PAT Guidance, transitioning from a conceptual framework into a cornerstone of modern pharmaceutical manufacturing. Today, a robust and converging regulatory landscape, spanning the U.S. Food and Drug Administration (FDA), International Council for Harmonisation (ICH), United States Pharmacopeia (USP), European Pharmacopoeia, and ASTM International, strongly supports PAT adoption as a key driver of quality, efficiency, and innovation.

Despite this progress, implementation across the industry remains inconsistent, highlighting a persistent gap between regulatory vision and operational reality. The complexity of navigating multiple regulatory frameworks and integrating advanced analytical tools into manufacturing environments presents significant practical challenges.

This presentation provides a roadmap to bridge these gaps by aligning regulatory expectations with practical implementation strategies. It focuses on best practices for PAT tool selection and validation, offering actionable insights to support compliance while enhancing product quality, manufacturing efficiency, and driving innovation in pharmaceutical manufacturing.

PAT Evolution and Implementation: Navigating Regulatory Guidelines, and Best Practices for Tool Selection and Validation

The value of PAT is underscored through its ability to enable real-time monitoring, enhance process understanding, improve product quality, and accelerate development and tech transfer.  However, successful deployment requires improvements in industrial systems and data infrastructure to support scalable, reliable use of PAT at manufacturing sites. This includes strengthening data integration, ensuring robust data pipelines, and enabling seamless transition of lab-developed PAT solutions to shopfloor execution environments. The presentation will address the critical need to develop scalable systems that simplify the integration of Process Analytical Technologies (PAT) into routine manufacturing while ensuring data integrity and regulatory compliance. It will emphasize that successful PAT deployment in a GMP environment requires a truly multidisciplinary approach, bringing together R&D CMC, MSAT, Quality Control, Quality, Regulatory, Operations, Engineering, Maintenance and Data Science functions. The talk will start on how to ensure a successful PAT continuum from R&D CMC toward Commercial Products and will deep dive on the adoption of standardized architectures, the implementation of robust PAT data and model management platforms, and the establishment of validated workflows aligned with GMP requirements. It will highlight practical strategies to enable sustainable PAT adoption and accelerate digital transformation in biopharmaceutical manufacturing.

Overcoming Bottlenecks in PAT Deployment: Bridging the Gap Between Lab & Manufacturing

This webinar will discuss considerations for building characterization assays to support early-stage saRNA development and alignment across CMC and quality functions. Emphasis will be placed on establishing fit-for-purpose assays to help define product quality and inform key development decisions.

Using potency as a case study, the session will outline the approach to method development, including efforts to establish stability-indicating capability. Key observations from method refinement will be highlighted, along with challenges encountered in ensuring robustness and interpretability of results across development stages.
Overall, the session aims to provide practical perspectives on developing and evolving assay strategies in support of early-stage programs, including considerations for analytical consistency, data integrity, and alignment with regulatory expectations.

Building Characterization Assays to Support Early-Stage saRNA Development and QC Alignment

Full title: Managing Analytical Procedure Lifecycles: Resolving Longstanding Mass Spectrometry Challenges for Emerging Nitrosamine and NDSRI Impurities

The nitrosamine crisis began in July 2018 when N-nitrosodimethylamine (NDMA) was discovered in valsartan products. The potential carcinogenicity of nitrosamines and nitrosamine drug substance-related impurities (NDSRIs) triggered recalls, global regulatory action, and a significant overhaul of drug quality control to prevent future contamination. In response, FDA laboratories rapidly developed and validated analytical methods for NDSRIs and nitrosamines, primarily using liquid chromatography-mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS/MS) techniques.         

The pharmaceutical industries are still facing significant analytical challenges in quantifying NDSRIs and nitrosamines due to their trace-level presence, chemical diversity, and matrix complexity. Additionally, mass spectrometry has not been routinely used in QC environment until recently and the ICH Q2(R1) Validation of Analytical Procedure guideline (2005) did not provide detailed recommendations for mass spectrometry methods. The presentation will discuss best practices for mass spectrometry based on analytical procedures for NDSRIs and nitrosamines based on FDA laboratories’ experience. These best practices and case examples of troubleshooting common analytical challenges shared in this presentation might help industries navigate the complex technical requirements while ensuring patient safety and product quality

Managing Analytical Procedure Lifecycles: Resolving Longstanding Mass Spectrometry Challenges...

In this presentation, the evolving landscape of aseptic manufacturing for advanced modalities including mRNA therapeutics, and Antibody-Drug Conjugates (ADCs) will be explored. The session will emphasize phase-appropriate process validation strategies tailored to the unique challenges of early-stage development. Drawing from recent regulatory guidance and practical experience, the talk will dissect the scientific and risk-based approaches to validation, including:

Aseptic Process Simulation (APS) as a cornerstone of sterility assurance

Bracketing and matrixing strategies for batch validation under constrained development timelines

Validation expectations for ATMPs and investigational biologics, referencing EMA and PIC/S

Annex 13 principles

Attendees will gain insights into: 

How to balance regulatory expectations with development agility.

The role of risk assessments in defining validation scope.

Strategies to ensure robust sterility assurance while enabling innovation in formulation and delivery technologies.

This session is designed for professionals involved in quality assurance , regulatory affairs, and technical operations, offering a pragmatic framework for navigating aseptic validation in the dynamic field of biopharmaceutical development.

Aseptic Manufacturing for mRNA, ADCs, and Novel Biologics

Biological drug products (biologics), such as therapeutic proteins, vaccines, and gene- and cell-based therapies, are produced through multi-step processes involving multiple materials that contact intermediates and introduce numerous leachables into the final drug product (DP). These steps include (i) purification of intermediates using chromatography, centrifugation, dialysis, filtration, and filling into final container closure systems; (ii) shelf-life storage; and (iii) in-use preparation of the DP. The respective materials include chromatography resins, filtration/dialysis membranes, tubing, collection bags/tanks, gaskets, valves, final container closure systems, and in-use preparation components. Consequently, assessing leachables risk in biologics is the most challenging compared to other types of DPs.

However, current guidances focus on assessing leachables only from single manufacturing components that are scored as high-risk for leachables and underestimate other components. Following these recommendations, manufacturers often design studies incorrectly by performing assessments only for selected components and not assessing the overall (cumulative) leachables in the final DP. Other issues involve using non-validated analytical methods that result in potentially high quantitation errors for compounds whose actual levels may exceed safety thresholds. Such issues usually cause multiple communications between the FDA and sponsors during application reviews, typically resulting in requirements to perform post-marketing assessments that burden both parties.

This presentation overviews the FDA’s approach and experience in reviewing information for leachables assessment and includes recent examples of representative review cases, aimed at facilitating proper leachables assessment. Our review experience has contributed to writing the ICH Q3E guidance draft, which is currently in the final stages of completion.

Analytical Assessment of Leachables in Biological Drug Products

ISO 10993‑18 is entering a new phase as several technical specification (TS) documents are developed to address long‑standing gaps and confusion in chemical characterization. These TS efforts aim to bring greater clarity to extraction design, identification confidence, quantitation strategies, and quality for better alignment with ISO 10993‑17 for toxicological risk assessment.

This presentation summarizes the TS documents currently in development, outlines their intended scope, and highlights how they may reshape expectations for E/L study design and reporting. Attendees will gain a concise view of where ISO 10993‑18 is heading and practical insight into how these evolving documents may influence regulatory submissions and laboratory practices in the future.

Followed by Rising to the Standard: How Advanced Analytics and Machine Learning Meet the New E&L Standards

Future Path for E&L per ISO 10993‑18: A Look at Emerging Technical Specifications

Full title: Are We There Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing.

Digital transformation promises to revolutionize biopharmaceutical manufacturing, yet most organizations leverage only a fraction of their process data — and the challenges are paradoxically increasing with digitization and globalization. Digitization does not automatically deliver analytics-ready data. New AI capabilities, from multivariate methods through foundation models and agentic systems, demand data infrastructure that most sites have never been asked to provide.

This webinar introduces BioMetre, a practical maturity framework serving as a GPS for process monitoring readiness, developed and deployed across a global biologics manufacturing network. The model scores data readiness along two axes: what process data exists across six categories, and how well it flows across six delivery dimensions — freshness, frictionlessness, accessibility, authenticity, structure, and availability. Assessments across 25+ products revealed scores ranging from 30–80%, with organizations excelling at collecting critical data but struggling to make it analytically accessible.

Drawing on nearly four decades applying AI to biologics manufacturing, Jack Prior will share practical lessons for identifying the specific data gaps standing between current operations and effective AI adoption — and why getting the data foundation right is the highest-leverage investment a manufacturing organization can make.

Are We There Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence...

Bringing biosimilars to market efficiently means making smart decisions early—especially around when to intensify your process and when to scale. In this webinar, you’ll explore how to confidently navigate those choices and set your manufacturing strategy up for long‑term success.

In this webinar with Cytiva we will walk you through practical approaches to process intensification and scale‑up, tailored to different facility footprints and portfolio goals. Whether you’re working within limited space or planning for multiple biosimilars, you’ll gain insight into strategies that can accelerate development while keeping costs under control.

You’ll also learn how to think proactively about cost of goods from the very beginning—so you’re ready to scale production smoothly, respond to market demand, and avoid costly rework down the line. Most importantly, this session will empower you to build efficient, flexible processes that help get high‑quality biosimilars to your target markets.

Designed for More Than Launch: Accelerating Biosimilar Manufacturing at Scale

Industry 4.0 is redefining the foundations of manufacturing, yet biopharmaceutical production remains one of the least digitally transformed industrial sectors. Despite major advances in artificial intelligence, mechanistic modeling, and data infrastructure, the industry continues to operate largely in conservative, segmented workflows where design, control, and manufacturing are only weakly connected. This talk challenges that status quo and argues for a shift toward truly intelligent biomanufacturing systems, where process design, modeling, and control are unified within a continuous digital framework. At the core of this transformation lies the integration of first-principles understanding with modern data-driven approaches, enabling predictive and adaptive decision-making across the entire product lifecycle. However, the path to Industry 4.0 in biomanufacturing is not blocked by technology availability, but by risk aversion, regulatory complexity, and the high perceived cost of failure. As a result, progress toward closed-loop, autonomous manufacturing is inherently incremental rather than disruptive.

This presentation explores how hybrid modeling, digital twins, and advanced control strategies can bridge this gap, enabling stepwise but sustained transformation. It argues that the future of biomanufacturing will not be defined by a single leap to autonomy, but by a deliberate re-engineering of how data, models, and decisions interact—ultimately reshaping how biological products are developed and manufactured.

Intelligent Biomanufacturing Systems: From Design to Control in Industry 4.0

Industry 4.0

Artificial Intelligence

mechanistic modelling

biomanufacturing

hybrid modeling

digital twins

data infastructure

advanced process modeling

smart manufacturing

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Intelligent Biomanufacturing Systems: From Design to Control in Industry 4.0

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