Name: New Drying Processes for Biopharmaceuticals
Start: 2020-05-05T14:00:00Z
End: 2020-05-05T14:01:30.000Z
Location: BrightTALK
Rating: 5

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: Validation of Test Result Equivalence for Alternative BET assays, Including Recombinant Methods

Both FDA’s 2012 Guidance for Industry and USP <1223> specifically use the term, “equivalence” as a requirement for validating an alternative test. Traditional methods, such as the Limulus amebocyte lysate (LAL) assay, are widely accepted and have a proven record of assuring parenteral drug and device safety, but they have limitations, including reagent variability and sustainability concerns. As a result, new methods using a number of innovative platforms, including recombinant technology (rFC and rCR), have emerged. The concept of test result equivalence bridges the gap between old and new technologies, offering cost-effective, environmentally friendly, and reproducible means of endotoxins detection, advancing the industry's ability to ensure continued product quality and patient safety.  This webinar will explore the concepts of equivalence, comparability, and statistical methods used to evaluate them.

Validation of Test Result Equivalence for Alternative BET assays...

It is a regulatory requirement (ICH Q5A Revision 2) to demonstrate viral safety of biotechnology product derived from in vitro cell culture, including viral-vector derived products like recombinant Adeno-Associated virus used as a delivery medium for gene therapy products. Viral clearance in gene therapy product poses different challenges from the other non-viral biotechnology product in the viral removal strategies. In this webinar, we will present a case study with a clinically relevant AAV8 downstream process:
1 The rationale of the study design: the choices of virus panel, surrogate and the unit operation for demonstrating viral clearance.
2 Present the clearance achieved in a scaled down model of the process

The Importance of Viral Clearance and Characterization in Gene Therapy Products

Presented by Pallavi Karnik, Analytical lead, Cell and Gene Therapy, Intas Pharmaceuticals Ltd.

Analytical Characterization of Viral Vectors and Plasmids

Full title: Current State of PAT Applications for a Reliable and Effective PCM Equipment Operation

PAT is an integral part of every Pharmaceutical Continuous Manufacturing (PCM) control strategy. On the other hand, PAT sensors can cause equipment and process inefficiencies due to the complex nature of those instruments. Sensor technology, data volume, sensor maintenance or the interface to the process contribute to operational complexity.

Nonetheless, PAT is required to measure Critical to Quality product Attributes (CQA), on-line or at-line and is enabling Real Time Release strategies. Furthermore, PAT sensors are also used during process and predictive model development, CQA monitoring, diverting Out of Specification (OOS) material and thus are essential for Real time Release testing applications.

Consequently, the selection of PAT applications is a critical step in every PCM business case assessment and during the entire engineering phase of a PCM system. This presentation will provide an overview of commonly used PAT sensor technologies and their selection criteria. Furthermore, it will revisit process design criteria for the optimal positioning of those sensors within the given process flow.

The overall control strategy defines what level of PAT implementation is necessary to run a successful continuous operation. All examples will be supported by real world PAT applications in operating PCM installations. 

Finally, this presentation should provide confidence in available PAT technologies. Innovation will aim for new even more sophisticated sensor technologies and new analytical software tools, but today PCM drug substances and drug product applications are covered and allow lead users to achieve the expected Overall Equipment Effectiveness (OEE) and required Net Present Value (NPV).

Current State of PAT Applications for a Reliable and Effective PCM...

Full title: Navigating the Digital Transformation for Biopharmaceutical Process Development: Harnessing the Power of Microbial Systems and Innovative Technologies

In this webinar, we will explore biopharmaceutical process development using microbial systems, such as bacteria and yeast. Key aspects include optimization of target protein expression, downstream process development, and high throughput approaches for rapid parameter screening.

The innovative smart Process Design platform will be central to the webinar, streamlining workflows and considering capacity limitations during process development. The importance of automation, parallelization, and integrated process models will be highlighted, enhancing efficiency, and facilitating data-driven decision-making for continuous improvement in bioprocess development.

The webinar will emphasize the unwavering commitment to leveraging advanced technologies and data-driven strategies in delivering innovative bioprocess solutions. This dedication drives the digital transformation of the biopharmaceutical industry, ensuring its position at the forefront of scientific and technological advancements.

Attendees will gain insights into the latest trends and best practices in biopharmaceutical process development using microbial systems. The webinar will underscore the significance of adopting a forward-thinking approach to process development, leading to more efficient, cost-effective, and sustainable solutions for the biopharmaceutical industry.

Navigating the Digital Transformation for Biopharmaceutical Process...

Full Title: De-bottlenecking Challenges in Large Scale Viral Vector Manufacturing for Gene Therapy Applications

The rush to develop an affordable and accessible COVID-19 vaccine not only accelerated research and development of therapeutic modalities like viral vector, mRNA and pDNA based vaccines but also challenged the bioprocess community to solve for unique scale-up related challenges to manufacture these important life-saving medicines. 

Adenoviral vectors are attractive vectors for delivering genes for other gene therapy applications. These vectors can accommodate large transgenes, transduce quiescent and dividing cells, and do not integrate into the host’s genome. Adenoviral vector technology using HEK293 host cells has been around for a long time and the manufacturing process includes upstream processing (HEK293 cell culture and viral infection), followed by series of clarification, filtration, and chromatography steps to produce drug substance with high purity. Although, the process unit operations seem uncomplicated, manufacturing at large scale in single use systems has remained a major challenge due to poor and inconsistent cell growth in suspension culture during scale-up, low viral titers, product aggregation, inefficient separation of empty and filled viral capsids, as well as complexities related to handling large volume viral infection. Hence, there is a strong requirement to build robustness and scalability in early process development to minimize unnecessary late-stage process changes, as well as design cGMP facility and strong quality culture to handle operational complexities and reduce risks associated with viral vector manufacturing. The webinar will illustrate key questions and challenges in large -scale manufacturing of viral vectors from a process robustness, facility design and product quality standpoint as well as our experiences in debottlenecking these challenges to scale adenoviral vector technology at 2000L and beyond.

De-bottlenecking Challenges in Large Scale Viral Vector Manufacturing...

Full title: A systematic approach to deliver data science solutions for bioprocess development leveraging digital infrastructure and data management solutions

A streamlined approach to analytics can play a crucial role in optimally using digital infrastructure and data management solutions to realize the full potential of advanced analytics for process development. We will discuss our systematic approach to develop scalable advanced analytics solutions including multivariate statistics, digital twins based on AI/ML, mechanistic or hybrid approaches, and more.  Emphasis will be laid on the strategy to democratize and decentralize development efforts and empower citizen data scientists to use these methods to bring new medicines to patients. A diversity of skill sets required to deliver these solutions, including collaboration with our IT partners will be presented. We will also share our experience in employing cloud-based analytics platforms to build an eco-system of data science products that are widely accessible for end-user consumption as well as to inspire other potential citizen data scientists.

A Systematic Approach to Deliver Data Science Solutions for Bioprocess...

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

Presented by Ahmed Zidan, Senior Staff Fellow (Pharmacologist) Center for Drug Evaluation and Research at FDA, Owen Rehrauer, President of Sentronic US Corp and Rodolfo J. Romañach, Ph.D. Center for Structured Organic Particulate Systems (C-SOPS) at the University of Puerto Rico

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...

Full title: Applications of Next Generation Sequencing for Viral Safety in Light of ICH Q5A R2

Applications of Next Generation Sequencing for Viral Safety...

Solvent Selection for Controlled Extraction Studies of Pharmaceutical Packaging Components: An Experiment-Based Approach

The 2006 recommendations from the Product Quality Research Institute (PQRI), Leachables and Extractables Working Group stated that extraction studies accomplished on pharmaceutical container closure/delivery system components should include “multiple extracting solvents of differing polarity”. This recommendation was later incorporated into USP General Chapter <1663>.  The intent of the recommendation was to ensure that extraction studies were comprehensive, and therefore had the greatest opportunity of discovering all potential leachables that could accumulate in a drug product over its shelf-life.  Since the laboratory studies accomplished by this PQRI working group focused on inhaled drug products and particularly on metered dose inhalers, the solvents used were dichloromethane, isopropyl alcohol, and hexane.  A second PQRI working group studied injectable and parenteral drug products which are aqueous-based, and therefore their laboratory work included water (with bracketing pHs) as an extracting solvent.  This presentation will summarize the scientific basis for extracting solvent selection for packaging components for all drug product types, including a discussion of the use of polarity index and other physical-chemical parameters.  Data obtained from extraction studies on various plastics and elastomers will be discussed. The possibility of developing standard methods for extraction studies will also be explored.

Solvent Selection for Controlled Extraction Studies of Pharmaceutical Packaging

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza

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

Presented by John F. Cipollo, Ph. D. Team Lead and Senior Principal Scientist, Global Biologics and Khaled Yamout, Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies.

mRNA Quality Assessment and USP Guidelines

Full title: A Digital Transformation Journey in Process Development – Building Automated Data Flows, from Equipment to eLN to Advanced Analytics
Sanofi CMC/Process Development is implementing a comprehensive Digital Transformation program to improve our productivity and reduce our development timelines. We are deploying a standardized digital workflow across our development sites globally (target: 2,000 users) and building automated data access to ensure scientists can document, visualize, and analyze their experimental work. We will discuss the progress, successes, and pain-points encountered by the development teams as we progress towards our digital ambition.

A Digital Transformation Journey in Process Development...

Full title: The use of AI and ML in pharmaceutical manufacturing - the evolving regulatory environment in the GMP and CMC Reg space in the US and Europe, illustrated with some application case studies.

The use of Artificial Intelligence (AI) and Machine Learning (ML) models in the GMP space has been discussed for a couple of years as one important element of an Industry 4.0 approach for Pharma. More recently, both the FDA - via a discussion paper on “Artificial Intelligence in Drug Manufacturing” - and EMA - as a topic for their Quality Innovation Group Listen & Learn Focus Group event -have shown interest in developing a regulatory framework or guidance for the use of these types of models.

This presentation will start with the larger evolving legislative framework on AI in Europe and the US, and then move on to describe the FDA discussion paper topics, as well as the EMA interest and potential next steps. The interplay between existing topics of regulatory interest, such as the use of modeling, and AI/ML-specific new aspects will be discussed. The presentation will also show some internal case studies and use cases that span the spectrum of potential applications (from knowledge management to process monitoring to more direct quality control), which many pharma companies are known to work on towards implementation in commercial manufacturing.

The Use of AI and ML in Pharmaceutical Manufacturing...

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals

Toxicological Risk Assessment on Extractables and Leachables

Full title: Leveraging Development and Commercial Knowledge for Root Cause Analysis of Commercial Near-infrared Methods

Bristol Myers Squibb manufactures a high-volume drug product which is tested for release primarily by Near-infrared spectroscopy (NIR) assay and content uniformity analytical methods. Due to the large testing volume, the performance of these NIR methods has been challenged with respect to system suitability, reference method comparability, statistical control limits, and release specifications. These events trigger investigations or proactive initiatives, which require root cause analysis. The determination of root cause for these NIR based methods is very different compared to the deviations and investigations typically encountered with traditional HPLC release methods. For example, NIR method performance events are rarely associated with laboratory error. Also, the multivariate calibration models and associated diagnostic metrics are abstract mathematical concepts, which can be difficult to interpret or assign to specific risk factors. However, within the appropriate context, the additional details available from these multivariate models can be leveraged to determine root cause. Appropriate context can be adopted from historical knowledge available either from the quality by design strategy used for NIR method development or from method robustness trends during commercial operations. This talk will discuss actual examples of leveraging these knowledge sources for root cause analysis of atypical NIR method performance events.

Leveraging Development and Commercial Knowledge for Root Cause Analysis...

HCP Analysis in Biopharmaceuticals by Mass Spectrometry 
Best Practices for HCP Analysis in Biopharmaceuticals by Mass Spectrometry Presented by Annu Uppal PHD. Director-Scientific Affairs & Strategy at USP 
And
Mass Spectrometry based Qualitative and Quantitative Profiling of HCP. Presented by Anita Krishnan, Head of Analytical Sciences at Biocon Biologics 
Mass spectrometry has become an increasingly common approach for identification and quantitation of Host cell proteins (HCPs) to support risk assessment and process development, as well as characterization and quality control. This presentation will provide an overview of the proposed general chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry. The best practices for instrument selection, sample preparation, LC separation, MS data acquisition, MS data analysis and reporting, with particular attention to the orthogonality of MS and traditional methods will be discussed. Additionally, there will be an update on the development of physical reference materials to support identification and quantitation of HCPs of particular concern.

HCP Analysis in Biopharmaceuticals by Mass Spectrometry

Presented by Dr. Parthasarathy Sampathkumar, Head, Group Center for Operational Excellence at Biocon Biologics and Sara Jane Bresee, Managing Director of APAC at MasterControl

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

Presented by Sune Klint Andersen, Principal Scientist at Janssen Pharmaceutical Companies of Johnson & Johnson

Sune Klint Andersen is Principal Scientist for Spray Drying at the Janssen Pharmaceutical Companies of Johnson & Johnson. He has a Ph.D. in Chemical Engineering. He has worked with pharmaceutical spray drying for 17 years within process development for R&D and commercial scale, application of Quality-by-Design and PAT, particle engineering, drying kinetics, aseptic spray drying and advantages and disadvantages of spray vs freeze drying processes. He previously worked at Novo Nordisk for 7 years.

and followed by Lars Markwort, co-founder and CEO of Bioinicia SL


Lars Markwort is co-founder and CEO of Bioinicia SL. He holds a Ph.D. in Chemistry and worked for 20 years in the analytical and process equipment industry, supplying mainly the semiconductor and pharmaceutical industries. At Bioinicia he is guiding the scaling up of electrohydrodynamic processes to industrial production with a focus on drying, micronization and encapsulating of labile bioactives for applications in pharmaceuticals and nutraceuticals.

New Drying Processes for Biopharmaceuticals

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New Drying Processes for Biopharmaceuticals

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