Name: Effective Extractable & Leachable Study Design
Start: 2025-10-08T14:00:00Z
End: 2025-10-08T14:02:00.000Z
Location: BrightTALK
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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.

Detection of bacterial endotoxins is a critical quality attribute of parenteral pharmaceuticals and medical devices.  Bacterial endotoxins are cell wall components of Gram-negative bacteria, ubiquitous in nature, difficult to destroy and can cause pyrogenic responses or worse.

We are at a generational change in bacterial endotoxins test method options.  Creating the infrastructure to enable broader use of recombinant reagents advances the science while maintaining the safety and quality of medicines.  Recombinant reagents are derived from established biotechnology principles which begin with the same mechanism of action as the natural protein derived from horseshoe crabs; the detection of bacterial endotoxins by the Factor C protein.  Recombinant reagents also afford improvements in quality, supply chain, and sustainability.

The USP Microbiology Endotoxin and Pyrogens Subcommittee developed a recombinant reagent bacterial endotoxins test chapter which is based on the underlying science, and data from the peer-reviewed literature, sponsor and supplier validations, and ring study trials.

The presentation will provide a general overview of the Subcommittee work, and detailed information regarding the recombinant bacterial endotoxins chapter, associated guidance, and the public health reference standard endotoxin.

An Overview of Recent USP Bacterial Endotoxins Standards Development

Conjugate vaccine development is a complex, complicated and lengthy process comprising of multiple antigenic vaccine components. The Serum Institute of India, a global leader, employs advanced data analytics and Design of Experiments (DoE) principles to develop and optimize Vaccines R&D and manufacturing. By integrating tools like Advanced Data Analytics, we've significantly enhanced yield consistency and process robustness from the initial stage of development.

This presentation will explore how advanced analytics and smart manufacturing are revolutionizing our vaccine development and production approach. We'll discuss addressing complex scientific challenges, scaling up early-stage data for commercial manufacturing, and leveraging real-time data analytics through high-performance online sensors.

I will also share insights into the application of Online Data Analytics platforms in establishing flexible QbD frameworks. Join us to discover how data-driven decision-making is driving impactful advancements in vaccine manufacturing using Predictive & Prescriptive analytics.

Vaccine Development using DoE and its Manufacturing Technology with the application of Advanced Data Analytics

Full Title: Potency Assays and Functional Characterisation—Going Hand-in-Hand during Product Development up to Commercial Licensing

The potency assay is a highly critical assay for cell and gene therapy products and is one of the assays on the release specification. The potency assay needs to reflect the main mechanism of action/s of the product and the CQA. Using cellular function characterisation assays during development provides critical insights which help to establish the most relevant and appropriate potency assay for the product.

Potency Assays and Functional Characterisation

The demand for Advanced Therapy Medicinal Products (ATMPs) to treat diseases continues to grow, and, for many patients, ATMPs represent the last treatment option. As a result, it is crucial for manufacturers to produce and deliver these therapies in a timely manner while ensuring they meet all required safety and efficacy standards.

With the introduction of new manufacturing and testing methods, such as automation, decentralized models, and rapid testing; adopting a risk-based approach for testing and releasing ATMPs is no longer optional—it is essential.

This webinar will examine the potential risks involved in enabling just-in-time or real-time release of ATMPs. We will assess each stage of an example traditional autologous manufacturing process and identify potential risks and the factors that could allow for more efficient, timely release of these therapies.

While the webinar will focus on autologous manufacturing as an example, the insights shared can also be applied to other manufacturing methods.
The views and opinions expressed during the webinar are those of the presenter and do not reflect those of Adaptimmune or its affiliates.

Just in Time Release of CAR T Cell Therapies

Conjugate vaccine development is a complex process. The Serum Institute of India, a global leader, employs advanced data analytics and Quality by Design (QbD) principles to optimize biologics R&D and manufacturing.

By integrating tools like Data Analytics and Online data acquisition from Reactors or bioreactors leading to Advanced Data Analytics software, we've significantly enhanced yield consistency and process robustness.

This presentation will explore how advanced analytics and smart manufacturing are revolutionizing our vaccine production approach. I will discuss addressing complex scientific challenges, scaling up early-stage data for commercial manufacturing, and leveraging real-time data analytics through high-performance online sensors.

Vaccine Development & its Manufacturing using Integrated High Throughput Technology

This presentation will cover the current sustainability challenges for biopharma industry and how biopharma industry should prepare to solve for this looming sustainability challenges. This talk will also indicate on some aspects of future of manufacturing processes through technological evolution.

Finally, the audience will also hear on a case study which stresses on how a technology evolution and process development can enhance the sustainability issues of Biomanufacturing. 

The second presentation will cover guidance of adopting Phase appropriate orthogonal high-end tools in early-stage product development and Selection of analytical tools for expedited biopharmaceutical development. This talk will provide overview on Significance of High throughput and sensitive analytical tools from Clone to Formulation ranking. This talk will also cover the contemporary challenges in HCP by ELISA and approach to defeat these challenges by alternate approach.

Enhancing Sustainability in Biopharmaceutical Drug Development and Manufacturing

Andrey Sarafanov; PhD., Principal Investigator at U.S. FDA, Center for Biologics Evaluation and Research
Presenting: Analytical Assessment of Leachables in Biological Drug Products: FDA Approach in Reviewing Information

Sandi Schaible, Executive Director, Analytical Chemistry and Regulatory Toxicology at WuXi AppTec

James Hathcock, Sr. Director, Regulatory and Validation Strategy at Cytiva

Analytical Assessment of Leachables in Biological Drug Products: FDA Approach in Reviewing Information

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

Presented by Yana Chervona, Drug Safety Team Lead in Drug Safety Research and Development at Pfizer

Read Across Assessment for Potential Leachables Without Toxicological Data

Cell and gene therapy (CGT) is particularly well-suited for the application of big data analytics.  Although our understanding of these complex therapies remains limited, CGT manufacturing processes and analytical methods generate substantial datasets that can be analyzed using artificial intelligence and machine learning algorithms. These advanced computational tools are instrumental in identifying critical characteristics of novel CGT products, optimizing manufacturing and analytical methods, and defining predictive biomarkers, among other applications. This presentation will discuss the role of big data in the development and manufacturing of CGT products and will explore opportunities for crowdsourcing data in the precompetitive space.

Big Data Strategies for Cell Therapy Manufacturing

Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters.  The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing for early-stage products that do not have the quantity of material required to easily and efficiently perform such testing.  Process and product parameters were varied to determine their effect on microbial retention.

A Quality by Design (QbD) Approach to Microbial Retention Validation of Sterilizing Filters

Continuous capture chromatography is a chromatographic technique promising higher efficiency through higher resin utilization, higher productivity and lower buffer consumption compared to batch chromatography capture processes.

Designing cSMB processes is more challenging than designing standard batch processes because each chromatographic phase is influenced by the previous phase. An iterative approach can be used to identify optimal conditions.

Our traditional process design approach was based on single column breakthrough curves and feeding the breakthrough data into a model. However, this concept leads to a sub-optimal process as it is based on a single loading flow rate during all phases, while effectively, flow rates and volumes in interconnected and parallel load phases should be different for an optimal process. In this webinar, I will present an approach where different flow rates and different breakthrough curves are used as model inputs together with pressure-flow dependencies for the resin of interest. Using the improved process design, significantly higher productivities were achieved compared to the standard procedure. The effect was confirmed for a given in-house model process with approximately 50% higher productivities which has been confirmed at laboratory scale. Finally, implications of the new cSMB design approach for large-scale manufacturing are discussed.

Optimisation of Continuous Capture Chromatography Processes

There has been much speculation and discussion of the universe of organic extractables; its size, its constituents, the nature of those constituents, etc. Knowledge about the universe is critical to establishing best practices for E&L.

In an effort to at least start the process of charting the organic extractables universe, Nelson Labs addressed the question of “what do we know about the universe from experience within that universe?” by performing a retrospective review of the many extractables studies that it has performed in the last several years. Study results were reviewed to establish what organic extractables had been reported in the studies performed over that period of time and how often the individual extractables were reported. Additional information about these extractables, including the methods they were detected with and their key analytical characteristics [e.g., relative response factors, retention indices (for GC/MS compounds) were abstracted from the compiled data and physiochemical characteristics of the extractables were collated from various sources.

The results of this data collection and analysis process will be discussed and the use of the information to establish best practices will be considered.

Charting the Universe of Organic Extractables

USP <86>, “Bacterial Endotoxins Test Using Recombinant Reagents” states, “Regulatory authorities may require supplemental data prior to acceptance…An example of supplemental data may include a comparative study of the material tested by techniques described in this chapter and those in 〈85〉.”  The term, “supplemental data” may refer to the use of a statistically robust analysis of test results obtained from a single sample containing assayable levels of endotoxins activity, using both the predicate assay (<85>) and the candidate recombinant assay (<86>) .

This webinar discusses the difference between 50-200% acceptance testing and statistical equivalence.  In addition, using data in the public domain as examples, the speakers will stress the importance of using a split sample containing assayable levels of contaminating or potentially contaminating endotoxins activity as the test article for these studies.

Beyond USP <86>:  Supplemental Testing

Full title: Advancing Biomanufacturing Quality Control with GMP Next Generation Sequencing (NGS): Regulatory Insights and Industry Case Study 

This webinar focuses on the established role of GMP-compliant Next Generation Sequencing (NGS) in Biomanufacturing Quality Control. With evolving regulatory guidelines addressing advanced therapeutic products, NGS offers a robust and highly sensitive approach to ensure compliance and product safety.

Key topics include an overview of the regulatory landscape, insights into GMP standards for BioPharmaceuticals, and a real-world industry case study demonstrating the practical application of NGS. The session will address common challenges, implementation strategies, and best practices for integrating NGS into quality control workflows.

Amina Cherif Louazani, PhD, Viral safety and Regulatory affairs at PathoQuest, will offer a deep dive into the evolving regulatory landscape for advanced analytical methods, providing clarity on expectations and best practices for implementing NGS in a GMP environment.

Complementing the regulatory perspective, Dave Briggs, PhD, Principal Scientist MS&T at Avid Bioservices, will present a compelling industry case study from a leading CDMO, illustrating the real-world application of NGS for product safety, and regulatory compliance.

Designed for professionals in quality control, regulatory affairs, and biopharma manufacturing, this session provides valuable guidance on leveraging NGS for enhanced safety in biopharmaceuticals.

Advancing Biomanufacturing Quality Control with GMP Next Generation Sequencing (NGS)

Using risk management to design aseptic process simulations:

Annex 1 states that “QRM (Quality Risk Management) applies to this document in its entirety”. Does this mean we can use QRM to justify non-compliance with Annex 1 requirements? The answer here is obvious: No.

So when and where can we use QRM? And for what purposes?

During this webinar we will go through several real and practical examples for using QRM to design Aseptic Process Simulations (media fills): 1) When using QRM is not allowed, 2) When it is permitted; and 3) When it is mandatory.

Using Risk Management to Design Aseptic Process Simulations

Establishing a personnel monitoring (PM) program requires a risk-based approach per the current EU Annex I. Presently, there is no specific industry or regulatory guidance on how to establish sample locations and sampling frequencies using Quality Risk Management (QRM) for personnel monitoring and the methodology behind a risk-based approach can vary greatly from site to site. Implementing a global risk-based methodology is desirable for consistency.  Takeda has developed a global personnel monitoring risk assessment tool that can be used across a range of production facilities.  This tool applies to both gowning qualification sample site determination and routine personnel monitoring associated with batch production.  Utilizing QRM principles, contamination hazards and sources were identified and assessed to inform risk scoring criteria.  The personnel monitoring assessment takes into consideration the process understanding of both gowning and manufacturing operations. A case study for the application of the risk-based tool will be presented.

Design of a Global Risk-Based Personnel Monitoring Assessment for a Multi-Production Operation Company

The topic will focus on the various aspects of study designs in order to perform for Medical device and Pharma product in a general view. The main focus will be on sample preparations, extraction techniques and quantifications approach in a systematic approach. This will enable to design the studies with scientific rationale. Also, I would like to discuss the aspects of dealing with Identification and classification of compounds observed in the E & L studies. The presentation is focused on approached to be followed while working with various categories of Identification level of compounds.

Effective Extractable & Leachable Study Design

EandL

Extractable and Leachable Study Design

Pharmaceutical Products

Medical Devices

LC-MS

Liquid Chromatogaphy

Pharmaceutical Packaging

Extraction Techniques

Mass Spectrometry

GC-MS

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