Name: RFC Implementation Strategy For Endotoxin Testing
Start: 2023-11-07T18:00:00Z
End: 2023-11-07T20:00:00.000Z
Location: BrightTALK
Rating: 0

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.

Full title: A Systematic approach to define operating space and MRT for continuous manufacturing ER tablets: Opportunities and Challenges

Twin-screw wet granulation is an emerging continuous manufacturing (CM) technology for solid oral dosage forms. Compared to batch operation, this technology offers several advantages including reduced processing time, uniform granule size distribution and shape, and real time process control. Continuous granulation process has been successfully employed for commercial manufacture of IR tablets. However, the high polymer content in the ER formulations has poised challenges by narrowing the design space of screw configuration and operating parameters. This design space defines the flow dynamics within the barrel and plays a crucial role in determining the granule properties. This work pursues a systematic approach for defining the optimum operating space and mean residence time (MRT) through understanding the interaction effects of the screw design and processing parameters on the critical characteristics of granules and tablets. The study identified further the opportunities and challenges of using CM granulation for manufacturing of ER formulations containing high load of swellable polymers.

This presentation will showcase a systematic approach for optimizing the operating parameters and process understanding of a twin-screw granulation to manufacture ER tablets. Examples of failure modes will be discussed, along with the implementation of quality-by-design coupled with PAT tools to monitor the critical quality attributes of granules.

A Systematic approach to define operating space and MRT...

Variability, Limits, and Other Considerations for the Next Generation of Pyrogen

Full title: Insights into Practical Issues Associated with Extractables Testing of Medical Devices

It is a well-known adage that “the devil is in the details.” As authoritative texts and regulatory guidelines that address the chemical characterization of medical devices usually present concepts and generalities and lack granularity, sponsors seeking to design and implement extraction studies for medical devices occasionally struggle to establish and justify critical experimental details that are scientifically sound, practical, achievable, and regulatorily compliant.

This presentation provides insights into several of these critical experimental details, addressing concepts that include:

The “It all comes out at Once” Paradox

Exhaustive Extractions as a Source of Kinetic Release Data

Predicting Exhaustive Extractions with a Minimum Number of Extraction Steps

A Rational (?) Approach to Quantitation and Managing the AET

Accurate versus Protective Quantitation

What exactly is a “Semi-polar” Solvent?

Insights into Practical Issues Associated with Extractables Testing...

Presented by Clare Blue, Director of Biologics / Gene Therapy Development at Biogen, Ryan Smith, British Pharmacopoeia Specialist at Medicines and Healthcare products Regulatory Agency and Franz Schnetzinger, lead analytical development and QC at Gyroscope Therapeutics, A Novartis Company

The British Pharmacopoeia Commission is producing non-mandatory best practice guidance for analysing advanced therapy medicinal products (ATMPs). This guidance ensures regulatory compliance, patient safety, and industry innovation. Non-mandatory best practice guidance can enhance industry practices, especially in technical fields such as biotech. Vector copy number and empty capsid ratio analysis are crucial in gene therapy development, and accurate analysis is essential for safety and efficacy. Best practice guidance can provide a standardised approach for consistency and encourage innovation. Organisations can learn from each other and improve the quality of research and development. The webinar will cover two guidance documents: Vector Copy Number and Characterisation of the Vector Particle Population of AAV Products.

British Pharmacopoeia’s ATMP Guidance

Endotoxins, otherwise known as lipopolysaccharides (LPS), are non‑infectious pyrogens associated with the cell membrane structure of Gram‑negative bacteria. This presentation outlines endotoxin detection challenges encountered during the development of a novel virus-like particle (VLP). Furthermore, this presentation provides a review of current methodologies accepted within industry to measure both endotoxin (i.e., LPS) and non-endotoxin pyrogens (NEPs).

Endotoxin Detection Challenges Associated With The Development Of A Novel VLP

This presentation will cover The Opportunity Landscape & Methodology utilized at Biocon to drive OE, The Group Level Structure & glimpses of The OE Framework.

Opportunities Landscape & Methodology

At Biocon, we believe that the most fundamental way of identifying Opportunities is by virtue of “The 3Ms.” These being Mura, Muri & Muda. These are Japanese terms that stand for as Un-evenness or variability, Overburden or Under-capacity and Wastes, respectively.

The Group COE (Center of Excellence) Structure

The purpose of The COE Structure is to identify, exploit and translate the opportunity landscape into viable improvements under the umbrella of Business Excellence Framework providing Centralized Governance and driving Institutionalization of OE Leveraging Digital Transformation.

Operational Excellence Framework – An Introduction

The OE Framework is an Agile, Scalable, Holistic yet Flexible Model with a capability to Balance, Integrate and Assimilate all existing and any future initiatives under One Umbrella including Digital Interventions. This encompasses the Strengths of tried and tested International Excellence Frameworks with high internalization & contextualization to The Biocon Group in totality. The individual elements of The Framework will enable seamless delivery of Business Objectives with a strong linkage to robust Business Processes.

Leveraging Digital Transformation To Deliver Operational Excellence

Full title: Development of a blending design space model to control uniformity in a Mini-Batch Direct Compression line

Blending is a common manufacturing unit operation for oral solid forms that is typically evaluated during formulation and process development with the aim to ensure proper distribution of the drug substance in the formulation, which is ultimately assessed during drug product release by means of the uniformity of dosage units by content uniformity. A common approach on how blend uniformity is controlled (but not tested) during commercial manufacturing consists in establishing appropriate blending conditions during the scale up from pilot to commercial scale. Those conditions are determined with a reduced number of experiments that usually do not provide the necessary process understanding on blending. 

Another alternative is to define the Design Space for blending, where a surface response curve allows setting the boundaries of the critical process parameters and critical material attributes by means of a multivariate process model.

The current webinar explores the development and verification of a design space model around blending on a Mini-Batch continuous Direct Compression line. This approach allows ensuring blend uniformity within specification for all Mini-Batches that are blended within the obtained design space. The approach brings flexibility to adjust changes in API particle size or fill level while ensuring proper blend uniformity.

Development of a blending design space model to control uniformity...

Full title: Navigating The Complexities of AAV Scale Up to Keep Pace with the Increasing Demand For these Viral Vector Delivery Systems

Modalis’ epigenetic editors are designed to efficiently target genes and control chromatin conformation by coupling an engineered Cas9 variant with epigenetic effector domains; referred to as GNDM (Guide Nucleotide Directed Modulation), which is delivered via a single AAV vector.

Most AAV capsids used for systemic treatments require high doses,

leading to safety concerns. To overcome such obstacles, Modalis has evaluated numerous novel AAV capsids allowing for reduced dosing, increased safety margins, and higher

therapeutic efficacy. These novel capsids do not always play nicely with standard manufacturing techniques and available reagents, so creative process development and analytics are needed to bring these promising therapeutic molecules to patients.

Navigating The Complexities of AAV Scale Up to Keep Pace with the Increasing...

Full title: Advanced Technologies for Media and Process Optimization for Biologics Manufacturing

Cell culture media composition and upstream bioprocess conditions are crucial factors affecting protein yield in the production of biologics and biosimilars. Recently, advanced new techniques were developed that use IT approaches, including computer simulation of bioprocesses, AI tools and ‘multi-omics’ methods for analysis of cellular metabolic pathways. These techniques allow optimization of both process and media composition for maximizing culture performance and protein production. In my talk, I will discuss the importance of cell culture media optimization and feeding conditions for achieving the most out of biologics pipelines. I will also discuss about other supplements that can help achieve faster cell growth and higher productivity.

Main topics of my talk:

DoE approaches for media formulation and feeding optimization

‘Digital Twins’ bio-simulations for reducing wet data requirements and allowing rapid optimization of feeding manner

Multi-omics and metabolic flux analysis for identification of metabolic bottlenecks and critical media components, for development of enhanced basal and feed media

Supplements for productivity enhancement

Advanced Technologies for Media and Process Optimization for Biologics Manu...

Full title: Application of Low Field Bench Top NMR for Upstream and Downstream Stages of Biomanufacturing Process

The development of applications using the low field bench NMR equipped with the flow cell will be discussed for selected process steps at upstream and downstream stages. In scope will be metabolite concentration measurement during fermentation, and concentration of residuals and excipients during antigen purification.

Application of Low Field Bench Top NMR for Upstream and Downstream Stages...

Presented by Dr. Wei Xue, Sr. Scientist at Ultragenyx Pharmaceuticals

Developing an Intensified AAV Production Process to Reduce CoGs

Full title: Evaluation of Optimal Extraction Conditions for Polypropylene, PBT Resins, and Chlorobutyl Rubber Elastomer - Using a Variety of Solvents and Extraction Conditions

Chemical safety assessment is one necessary step to demonstrate that the polymer used is free from harmful chemicals. The assessment should start with adequate material characterization using state-of-the-art analytical methods, including various chromatography techniques most often hyphenated with mass-spectrometric detection. Since polymers are usually incompatible with direct analysis using chromatography-based techniques, an extraction step is required prior to analytical testing. This paper provides information for practitioners who need to understand how to develop science-based extraction conditions that enable the determination of the polymer composition with respect to volatile compounds. Analytical data sets for three types of polymers (polypropylene, polycarbonate, polybutylene terephthalate, and a rubber elastomer) are presented using three different solvents and three different extraction techniques. The extracts were collected at different times during extraction and analyzed by GC-MS. The differences observed between extraction techniques, conditions, and solvents are discussed to better understand the impact of these parameters in extractable studies.

Evaluation of Optimal Extraction Conditions for Polypropylene, PBT Resins...

This presentation will outline Quality and Compliance Requirements For Cell and Gene Therapy Products which incudes”:

- Facility compliance

- GMP quality Management system

- Consideration in IPQA checks and batch release procedure

- Consideration in “ Patient to product tracking system”

- Temperature-controlled clinical trial supply chain

Quality and Compliance Requirements For Cell and Gene Therapy Products

Full title: Medical Device Chemical Toxicological Risk Assessments: Applying Toxicological Principles to Meet the Challenge

Medical device chemical toxicological risk assessment is challenging because the risk assessor often needs to consider the many types of device intended uses, many types of materials used in design and manufacturing, and many types of intentional and unintentional chemicals that are or could be present in the final finished device. Medical device intended uses include the type of tissue contact, the contact frequency and duration, and susceptibility of the device user to chemical exposure. Material factors include the material type (e.g., alloy, polymeric, ceramic, or natural), material properties (e.g., alloy surface characteristics, polymer plasticity, or polymer manufacturing process) and material chemical composition (e.g., chemical formulation, potent toxicants (if present), and the rate and duration of release). How to apply these considerations is described in the U.S. Food and Drug Administration (FDA) 2020 guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”, International Standard Organization (ISO) 10993 series, and ISO 14971. This presentation will describe how chemical toxicological risk assessment fits into the overall medical device biological risk management process (i.e., risk analysis, risk evaluation, or risk control). Additionally, what medical device chemical toxicological information to consider from the U.S. FDA 2020 guidance and ISO documents when estimating chemical toxicological risk will be covered, such as: approaches for estimating an exposure dose, deriving a tolerable intake (TI), and other critical factors to consider that could be useful in the determination of whether exposure to a medical device chemical presents a tolerable risk or could present a possible toxicological risk.

Medical Device Chemical Toxicological Risk Assessments...

Digitalization has been used in a lot of biopharma processes. A lot of data are collected through sensor and process measurement and already used in Machine Learning model. However, regarding Incoming material that may have a huge impact on final drug products not much has been done. Historically this was due to the fact that exchange of data with interfaces was quite difficult. This is changing. Through this Webex we want to show advantages of collecting such critical material data from supplier. We will discuss standard and tips on  how to collect data and interact with supplier regarding incoming material. Concrete examples on how GSK use such tools will be shown. Future trends on how digitalization could be applied to more specific  Incoming material such as Single Use will be developed. Example in the field of extractable and leachable, design or investigation will be explained with expected benefits. This will show you that a new world is opening to all of us with digitalization tools.

How Digitization Can Improve Bioprocessing and Make Manufacturing More Robust

During biopharmaceutical development large data volumes are generated in many stand-alone devices. Furthermore, with increasing projects and requirements to compress development timelines, high throughput and automation systems are being increasingly implemented. The resulting high pace of data generation augments error rates thereby risking data integrity.

This presentation will provide insights into the strategies and tools for data collection, storage and visualization to transform data into knowledge ensuring leaner, more efficient and integral data generation.

An assessment for each process step and equipment connectivity was performed to map, categorize and highlight gaps during data generation. Based on this preliminary assessment, a data architecture composed of multiple tools was designed to close gaps associated to data traceability, integrity & amp; extractability. Moreover, to support decision-making, multiple modelling tools were developed to focus on specific needs during process development, including process optimisation.

Through increasing instrument and system automation & amp; interconnectivity, data traceability, extractability and searchability are improved, and lab efficiency is increased by >20%. Moreover, with the use of mechanistic models, prediction of culture performance becomes a reality uncovering optimized feeding strategies to significantly increase productivity. In summary, our combined data architecture and process modelling techniques provide better insights thus improving process understanding while accelerating process development.</p>

The road to digitalisation of a research Lab

Presented by Johannes Scheiblauer, Associate Scientific Fellow for Digital CMC at Takeda and Sean Bermingham, Head of Formulated Products at Siemens

Several enabling technologies change the way we do pharmaceutical development: automation & digitalization, advanced analytical methods, modeling & simulation. But especially the latter are not silver bullets, and it is important to have a closer look why and when one might use them.

In this presentation, we focus on the real-time applications of modeling & simulation in the context of process monitoring & control: how to leverage the underlying technologies to better visualize current process data, improve process control decisions and anticipate future process trajectories.

We discuss factors and prerequisites supporting a successful and sustainable implementation, from the “digital maturity” of the processes over the necessary technical building blocks (like robotics & high-throughput experimentation) to aspects of people mindset and change management: what it means for an organization to embrace these new ways of work.

Deploying Modeling & Simulation to Enable Advanced Process Monitoring & Control

Presented by Lindsey Silva, Ph.D. Director, Microbiology in Analytical Sciences at Genentech, Evelyn Der, Senior QC Scientist at Genentech and Kevin L. Williams, Endotoxin Sr Scientist at bioMérieux

The webinar will provide insight into the regulatory landscape for recombinant Factor C (rFC) implementation as a sustainable endotoxin test method. A range of considerations for method validation activities to ensure health authority acceptance will be covered in the webinar including rFC method validation requirements as an alternative non-pharmacopeial method, rFC method implementation considerations for pharmaceutical water and product testing, and rFC method transfer strategy for QC network adoption.

RFC Implementation Strategy For Endotoxin Testing

Endotoxin Testing

Quality Control

Validation

Recombinant Factor C

Microbiology

(RFC)

Analytical Sciences

Biologics

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RFC Implementation Strategy For Endotoxin Testing

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