Name: Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum
Start: 2020-08-20T04:30:00Z
End: 2020-08-20T05:36:00.000Z
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.

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

Downstream protein purification and product concentration is known to be the most challenging part of the process development. It is also known that the Downstream process development is critical to ensuring protein drug quality, safety & efficacy meet regulatory expectations. When initiating the development, the Chemistry, manufacturing and controls considerations for process development and manufacturing must include molecule complexity. Raw materials, process development. Equipment and manufacturing, Quality and Regulatory Affairs

The critical factors for development and manufacturing is performing a stage-wise assessment on Product development, analytical and process development and not least, the manufacturability assessment. The expected qualities of a superlative process shall include increased capacity, flexibility, cost-effectiveness, controllability, scalability, and efficiency

However, general challenges exist in downstream process development involving,

Balancing higher cost chromatography resins and solvents
Constrained purification space for molecules prone to degradation at a wide range of pH and temperature
Process fit to multi-product facility,
PAT availability to accelerated processing
Adaptation of new technologies is one of a smarter way to address the challenges:
Non-Protein A process
use of next-generation chromatography resins
Continuous processing for capture, intermediate purification, Viral clearance

Best Practices of Downstream Protein Purification and Product Concentration

This webinar will outline elements to consider in the ruggedness and robustness of methods of analysis for nitrosamine from elastomers used in pharma. It will present a review of sources of nitrosamines in elastomers, together with how these have changed over time. It will give a chronology of the concerns and regulatory interest in nitrosamines over the last forty years. It will review choices that need to be made for methods of analysis during development of a method, and it will explore how those choices might influence the quality of the method produced. The webinar will present key factors to consider when creating a robust and reliable method and how analysis of pharmaceutical elastomers must consider the sample preparation considerations which may be specific to this application. The webinar will also illustrate the validation of a method for nitrosamines and show each element of the validation to consider together will hints and tips to ensure any method is both robust and rugged when challenged and operated in routine use.

Ruggedness and Robustness in Nitrosamine Analysis from Pharmaceutical Elastomers

Full title: Technologies and Platform Approach for Optimizing Downstream Purification of Viral Vectors

The promising success stories and advancement of viral vector-based gene therapy are emblematic of the future of Gene therapy. With the promising future, we still see multiple setbacks and technological challenges towards manufacturing and the higher cost of drug products, which makes it clear that technological challenges must still be overcome, working together with the Gene Therapy industry.

The viral vector production and purification processes are widely divided through the use of different technologies and tools available across industries. Therefore, a platform approach will be beneficial for harmonizing production processes for multiple viral vectors, which will help in optimized manufacturing efforts, thus reducing the cost of goods for manufacturing.

Adeno-associated virus (AAV) and Lentivirus (LV) are two major viral vectors being used for in-vivo and ex-vivo gene therapies respectively, which have unique manufacturing challenges of their own. Based on the multiple serotypes of AAV or multiple pseudo-typing strategies for Lentivirus, the process development is challenging. In this webinar, we will provide an overview of technologies available for the production and downstream purification of AAV & LV vectors and how utilizing the platform approach can help in optimization and reducing the cost of manufacturing.

Technologies and Platform Approach for Optimizing Downstream Purification...

In this webinar, Lawrence De Belder will give an overview of the history, present, and expected future of continuous manufacturing for drug product, drug substance, and biologics. This talk will cover the evolution of equipment design where simplification and modular design are increasingly important. To reap the benefits of continuous manufacturing, business strategies have evolved differently in various areas of the world, while support from worldwide health authorities has shifted over time. Initial thoughts about benefits have adjusted now that more data from industry is available and assumptions can be based on reality instead of estimations. Science has helped to build the rationale behind robust control strategies; valuable knowledge is being shared through clusters of consortia – to be combined in a central repository in the future. Will this evolution help to reduce the barriers of widespread adoption? What might trigger exponential growth of the amount of approved continuous processes? This webinar will describe the aspects that are critical in an integrated continuous manufacturing approach and discuss the logical consequences of market demand and quality control that will assure the future.

Followed by CM re-invented: A novel solution for Continuous Direct Compression (CDC)

Presented by Jan Vogeleer, Managing Director at Fette Compacting

Trends and Future of Pharmaceutical Continuous Manufacturing

-Migrating Bioprocessing into the Existing Infrastructure with Carefully Controlled Risk Management Systems

-Addressing The Opportunities and Challenges Associated with Continuous Bioprocessing and The Importance Data Integrity and Management

-Discussion On The Challenges Specific To Continuous Manufacturing Such as Process Optimization, Process Characterization, Automation, In-Line Process Analytics

-Emergence Of Continuous Manufacturing As The Preferred Manufacturing Platform

Challenges And Opportunities Of Continuous Bioprocessing And Risk Management

The counterfeit business is booming. Counterfeit goods account for a whopping 27 billion EUR revenue lost annually in the Pharma industry due to counterfeits. Moreover, it has an extensive negative impact, leading to product recalls lawsuits, consumer illness or death, and eventually, long-term reputational harm. Blockchain helps tackle counterfeiting by identifying the provenance (i.e., proof-of-origin) of a product because blockchain provides a secure and trusted tracking system from one end of the supply chain (the creation or mining of raw materials) all the way to the other end of the supply chain (where the end user enjoys the finished product). Because blockchain can identify provenance, legal enforcement agencies can more conclusively establish the counterfeit nature of suspect products, and pharma companies can protect their bottom line, ultimately stabilizing and creating a more resilient supply chain

Stabilising The Biologics Supply Chain with Blockchain

Full title: Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture: Updates from a CDER Microbiologist's Perspective

During this webinar, Dr. Metcalfe will:

Provide a short background regarding FDA concerns pertaining to Burkholderia cepacia Complex (BCC) and the manufacture of non-sterile drug products

Provide reference to pertinent areas of the 2021 FDA Draft Guidance for Industry-Microbiological Quality Considerations in Non-sterile Drug Product Manufacturing

Present recent events in the US pertaining to BCC

Explore recent FDA Warning Letters to address common industry questions regarding BCC and the manufacture of non-sterile drugs

Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture...

Continuous processing is being explored in various ways throughout the biopharmaceutical industry.  New process technologies and business considerations are driving process design towards more agile, modular, and highly productive paradigms.  Continuous manufacturing provides potential benefits such as reduced process scale and the implementation of single-use technologies.  However, these benefits may come at the cost of complexity.

This presentation will review a case study analyzing the conversion of a traditional GMP process into a continuous manufacturing paradigm. Discussion will include the development of integrated continuous operations, control strategy, and process design considerations.  The outcomes of the process conversion will also be discussed.

GMP Implementation of Continuous Manufacturing: A case study

The presentation aims to provide an overview of challenges that can be faced with the knowledge that a one size fits all approach cannot be taken. While individual challenges may not be unique to cell therapies. They way they can impact cell therapy facilities can be unique with additional considerations given the nature of cell therapy products and production methods. Each process and facility is unique with some processes far removed from a traditional biologics facility and others that may be closely aligned with traditional production methods. Challenges outlined in the presentation related to some aspects that are related to process and materials that can be presented during cell therapy manufacturing. These include:

Shelf life considerations for starting materials and finished product

Contamination Control Schemes for Facilities and it’s importance in facilities.

Control of personnel and the “human aspect” of cleanroom control.

Manual nature of cell therapy production.

Risk Reduction measures.

Criticality of right first time

Benefits and Drawbacks of isolator Technology.

Contamination Control Challenges Facing Cell Therapy Facilities

Full title: Points to consider when defining a microbial control strategy for individualized ATMPs

How are individualized ATMPs different from traditional drugs and off-the-shelf ATMPs?
Regulatory background
Microbiological testing: be smart and keep it simple
The importance of raw material control
ATMPs: A mindset challenge for Microbiologists

Points to consider when defining a microbial control strategy...

Full Title: Adaptation of the analytical control strategy of a commercial vaccine using the principles of QbD. Challenges, lessons learned and improvement perspectives.

The principles of Analytical Quality by Design (AQbD) were applied in the context of revisiting the control strategy applied to a recombinant protein antigen used in a commercial vaccines. Tools and approaches that were initially designed for applying AQbD on the development of analytical methods for new products were used. The objective of this presentation is first to advocate that QbD and AQbD principles can be advantageously applied to the lifecycle of commercial products and corresponding analytical methods. Second, to share the specific difficulties encountered on some items; but also, sometimes the surprising easiness on other items; and this precisely because we were working on a commercial product. Finally, we want to discuss the pro’s and con’s of applying (A)QbD principles, approaches and tools on commercial products and what would be the best route(s) between a systematic & dogmatic application of these principles and a conservative omission.

Adaptation of the analytical control strategy of a commercial vaccine...

Production of data is a costly business for Biopharma, always under scrutiny, and this is highly unlikely to change.  On the other hand, AI/ML is de facto data hungry and its success, by any metric, predicates on an abundance of data. It may thus seem paradoxical that in a world evangelizing a “do more with less” mentality, the future of labs in Biopharma is intertangled with that of AI/ML. But this is precisely what a Realpolitik analysis yields, taking into account cost, productivity, capacity and Director’s law. In this webinar, we will start by providing a sketch of this analysis and corroborate our assertion with empirical evidence from the bioprocessing sector. We will then move to drafting a roadmap for building the lab of the future as an amalgam of wet and dry labs. In so doing, we will deal with different aspects that naturally arise including, but not limited to, the automation vs augmentation and the insourcing vs outsourcing dilemmas. A central part of this roadmap concerns culture and change management. In the Industry 4.0 era, and owing to the omnipresence of social media, traditional psychological distance mechanisms have been demolished. In turn, this manifests as an overspread fear of robotization which triggers a “Newtonian” appeal to tradition response. Change management, an ominously perceived task in general, becomes even more arduous. While silver bullets for change management do not exist, we will provide some escape stratagems stemming from the newly defined concepts of integrated innovation and “back-to-the-future” perspectives.

Building the Lab of the Future Through AI, ML & Cultural Change

Presented by Presented by Melanie Dumarey, Product and process design engineer (associate principal scientist) at AstraZeneca

Advanced digitalization plan for AstraZeneca's CDC line

The commercial success of monoclonal antibodies has made biologics become attractive to pharmaceutical companies . The approval pathway is often required to extensive chemistry, manufacturing and control (CMC) study to ensure the long‐term safety and efficacy of biologics. However, the CMC studies remains labor intensive and time consuming. Reduction of CMC time has become one of the most important technological advantages for a biological therapeutic developer. Therefore, the ability to develop a biologically active molecule at the short duration via cell culture platform has become the key of successful biologic development. The priority of biologic companies is to acquire and develop cell culture technology platforms that enable them to speed up their CMC process; and to reach clinical trials quickly. Hence, we will discuss current cell culture technologies that are relevant to CMC development.

Platform Technology To Speed Up CMC Process

Full title: End-to-End Single-Use Manufacturing at Pilot Plant for Early Development Clinical Material

The Single Use Item within the Pharmaceutical industry is becoming more and more popular. What it is about to run End to End Single Use Facility? What challenges it brings with it and what opportunities? How can we make sure that we create this safe environment to have open dialog between the pharm industry and the supplier?

End-to-End Single-Use Manufacturing at Pilot Plant for Early Development...

The webinar will provide an insight into a global deployment program for an automated solution for Endotoxin testing. A range of implementation aspects will be covered in the webinar including the change management approach for a global platform technology, technical implementation challenges and how they were overcome and harmonization of business processes and best practices within a global company.

LESSONS & BENEFITS GAINED FROM THE IMPLEMENTATION OF AN AUTOMATED BET SOLUTION

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: Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).

Followed a Presentation by David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering

Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum

Biologics

Data Driven Models

Data Analytics

Machine Learning Process Controls

Process Intelligence

Process Development

Bioprocessing

Process Modelling

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Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum

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