Name: Read Across Assessment for Potential Leachables Without Toxicological Data
Start: 2025-08-13T14:00:00Z
End: 2025-08-13T14:02:00.000Z
Location: BrightTALK
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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

Specific risks of production cell lines will be discussed, in particular rodent cell lines often used for the production of recombinant proteins and human cell lines for the production of viral vectors for use in gene and cell therapy.

The topics covered will include virus and TSE risk of a cell line considering its nature and origin and its exposure during generation and culture to materials of concern, but also implications due to cell line clonality and homogeneity issues.

Depending on the outcome of a cell line risk assessment, possible mitigation strategies and risk-based analytical quality strategies are proposed to ensure the safety of a cell substrate for production of biological drug substances for use in humans.

Risk Assessment and Mitigation Strategies for Production Cell Substrates

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

Presented by Therese Choquette, PhD. Head of Analytical and Translational Sciences at Tigen Pharma, Ulrike Herbrand, Scientific Director Global in vitro Bioassays and Head of the Bioassay Research & Development team at Charles River Laboratories and Felix Montero Julian, Vice President of Scientific Affairs at Accellix

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.

Adressing the CQA Potency for ATMPs: A Risk-Based Phase-Appropriate Approach

Determining which attributes are critical to the quality of the product and the safety of the patient is individual to each product. During the lifecycle of an ATMP managing CQAs evolves through the different phases of development (early phases might focus on identifying potential CQAs and understanding their impact, while later phases involve more rigorous control and validation). Potency assays are a major challenge since often the mechanism of action (MoA) of the product is not fully understood in early phases. In those cases, a matrix approach with incremental development using less complex methods in the beginning can help to ensure avoiding delays on the path to market. Alignment with regulatory guidelines is crucial at any stage.

Potency Assays and Functional Characterisation

Ensuring viral safety in oncolytic virus manufacturing can be particularly complex when neutralizing antibodies interfere with traditional biosafety assays.

In this session, we will explore how GMP NGS enables accurate detection of adventitious agents and supports risk mitigation when antibodies threaten viral safety assessment. You’ll gain insight into regulatory expectations, case studies, and how integrating NGS-based biosafety into your workflow can de-risk development and accelerate timelines.

Key takeaways:

Addressing antibody neutralization in oncolytic virus GMP manufacturing
Enhancing biosafety with validated NGS approaches
Real-world applications and regulatory insights

Secure your place today and explore how GMP NGS empowers oncolytic virus manufacturers to ensure viral safety and, speed up timelines.

Oncolytic Virus GMP Manufacturing: Solving Antibody Neutralization Challenges with Next Generation Sequencing

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

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

Organic extractables & leachables surfaced by GC/MS are often identified by mass spectral matching (MSM) in which the experimental mass spectrum is matched to reference spectra contained in a spectral library.  The compound is “identified” as being the compound whose reference mass spectrum best matches the experimental spectrum, which often leads to flawed identifications.  

A compound’s Retention Index (RI) is an independent means of corroborating the proposed MSM identities.  A compounds’ analytical RI can be matched to reference RIs contained in a RI database (e.g., NIST23).  The identity secured by MSM is corroborated when the experimental RI acceptably matches the reference RI of the compound proposed by MSM.

Practical use of RI matching requires that acceptance criteria be established to define when an acceptable RI match has been achieved.  Acceptance criteria for RI for supporting, rejecting, or accepting proposed identities were established (based on a confusion matrix) using experimental values for RI for 3140 compounds, secured by Nelson Labs and reference RI values found in the commercially available NIST23 library.

For 71% of the 3140 compounds, the difference in Retention Index (between the NIST reference RI-value and the experimental RI-value) was less than ΔRI≤20. 96% of the candidate structures, obtained via mass spectral matching, were rejected correctly when applying a rejection criterion for the difference in Retention Index (between the NIST reference RI-value and the experimental RI-value) of ΔRI>50.

In addition, some other very interesting conclusions could be drawn from this large data set which will be an eye opener to many GC/MS-practitioners. The above conclusions will be applied to 10 case studies showing how these “general rules” can be put in practice and how they can help securing the right identity of a compound using Mass Spectral Matching.

Consideration how to use Retention Index information to support Mass Spectral Matching based identifications in GC/MS

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

Monitoring Downstream Purification with Raman Spectroscopy using the Procellics™ Raman Analyzer
Presented by Greg Voyta, Senior Engineer, Upstream Process Development at MilliporeSigma
Raman spectroscopy is a process analytical technology (PAT) with broad use in the biotech industry for its high selectivity and ability to monitor a variety of components simultaneously without impacting product quality. Traditionally, Raman spectroscopy has been focused on upstream processes to monitor nutrients, metabolites and cell composition, but significant interest has arisen in recent years in applying the technology in downstream unit operations such as tangential flow filtration. Raman spectroscopy offers in-line sensing and frequent measurement, enabling rapid decision making required for downstream process parameter adjustment. This webinar outlines the workflow of developing chemometric models for Raman spectroscopy and two case studies supporting implementation in TFF applications: Monitoring DMSO solvent clearance to below the 5000 ppm ICH guideline target following an antibody-drug conjugation reaction; and measuring highly concentrated mAb drug substance such as in final UF where high frequency intervals, low relative error and flow independence are key enablers.

ProCellics™ Raman Analyzer for ADC Solvent Clearance Monitoring during TFF
Presented by Dr. Kim Nguyen, Senior Scientist at the ADC Bioconjugation template Innovation department in MilliporeSigma

ProCellics™ Raman Analyzer Supports Rapid Decision Making With Highly Concentration Drug Substance
Presented by Alexander Farris, Bioprocessing Engineer at MilliporeSigma

Monitoring Downstream Purification with Raman Spectroscopy using the Procellics™ Raman Analyzer

Exploring the Impact of Transfection Complex Size on Productivity and Product Quality in AAV Manufacturing.

Reviewing Benefits and Limitations of Current Methods for Controlling Transfection Complex Size.

Implementing Scale-Independent Transfection through Strategic Control of Complex Assembly.

Enhancing Process Robustness through Automation and Process Analytical Tools.

Why Transfection Complex Size Could Make or Break AAV Manufacturing

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

Over the past few years, the mass spectrometry-based Multi-Attribute Method (MAM) has gained traction due to its potential to streamline lab work and decrease development time. However, several barriers to adoption remain, one of which is evaluating performance of MAM vs. conventional methods.  

To evaluate the performance of MAM vs conventional methods, adalimumab and etanercept were procured from multiple sources, and subjected to forced degradation to generate a range of modifications. Samples were analyzed using both conventional and MAM approaches to evaluate size variants, charge variants, glycosylation, sialic acid content, and other molecular variants like oxidation, deamidation, and glycation.

The ability of each technique to detect differences between nominally similar products and forced degradation-induced changes was evaluated. Physiochemical differences were compared to functional and structural changes detected using cell-based assays, binding assays, and circular dichroism. The knowledge base from this study can help lower the barrier to adoption of MAM, enabling greater efficiency and reducing costs.

Enabling Broader Adoption of MAM: Comparison of MAM vs. Conventional Methods

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, Associate Vice President, Global Analytical Services at NAMSA

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

Main title: Quality by Design: Enhancing Biopharma Validation and Microbial Retention Assurance in Sterilizing Filters

Quality by Design and its Impact on Biopharma Validation
Presented by Gregory S. Blank, Ph.D. Independent Consultant and retired Director, Late Stage Purification Department at Roche Genentech

Assuring performance in sterilizing filters: a supplier’s perspective
Presented by Annie Leahy, Senior MSAT Manager at MilliporeSigma

A Quality by Design (QbD) Approach to Microbial Retention Validation of Sterilizing Filters
Presented by Jennifer Juneau, Senior Principal Scientist at Pfizer



A Quality by Design (QbD) Approach to Microbial Retention Validation of Sterilizing Filters
Presented by Jennifer Juneau, Senior Principal Scientist at Pfizer

Quality by Design: Enhancing Biopharma Validation and Microbial Retention Assurance in Sterilizing Filters

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

Toxicology

Extractables

Leachables

toxicological assessment

computational tools

single use technology

single use aseptic connectors

toxicological data

pharmaceutical manufacturing

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Read Across Assessment for Potential Leachables Without Toxicological Data

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