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A risk based approach to continuous processing

The article considers the opportunities for risk based change in facility design through quality by design (QbD) and advances in PAT. It suggests that the inclusion of a mix of biopharmaceutical products alongside oral solid dose products could work based on a manufacturing dancefloor concept. Further that both upstream and downstream may be considered in a new light with the potential for in-process real-time testing and approval significantly reducing or withdrawing entirely the need for work-in-progress (WIP) inventory and quarantine storage needs as supply chain management processes integrate.
Recorded May 14 2015 60 mins
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Presented by
Rob Bowen
Presentation preview: A risk based approach to continuous processing
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  • Challenges in the Development of Continuous Processes for Vaccines Jun 27 2018 3:00 pm UTC 75 mins
    Danny Vellom
    The development and application of continuous manufacturing processes for vaccines presents both great opportunity as well as significant challenges, both technical and cultural, for the global industry. The key drivers are manufacturing capacity and flexibility, speed to market, and improved quality through the application of Quality-by-Design and Process Analytical Technology (QbD/PAT). Given the diversity of immunogens (toxoids, conjugate and subunit vaccines, live-attenuated and inactivated viruses, VLPs, etc.), and the variety of unique processes currently utilized to produce either single- or multi-component vaccines, it is unlikely that the transition to continuous processing will happen overnight. Additionally, cultural challenges are faced whenever a new mode of operation appears to some as “too different”, especially in a traditionally conservative sector like the developed-world vaccine industry. That said, market forces, global climate change, and Nature’s propensity to fill unoccupied niches with emerging infectious diseases will undoubtedly induce a first round of pioneers to explore this exciting new design space, ultimately leading to a more nimble industry and more and better opportunities for protection for the global population.
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production May 12 2018 2:00 pm UTC 75 mins
    Sune Klint Andersen, Janssen Pharmaceutica
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
  • Key components of a comprehensive program for the management of single use techn Apr 19 2018 2:00 pm UTC 75 mins
    Mark Maselli
    As a result of the increased adoption of single-use technologies (SUTs) in biotech manufacturing, companies need to develop and implement programmatic approaches for the management of these systems under regulatory compliance. This article discusses the key aspects of such programs, with emphasis on collaboration with suppliers, cost management, as well as practical insights about the use of SUTs.
  • SUS Leachable Testing: Leachable Study Design for Single-Use Components Mar 20 2018 2:00 pm UTC 75 mins
    Kathryn McGohan
    The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharmaceutical and Vaccines Manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the Best Practices for Leachables Study Design by end users and will include a case study to highlight the importance of the study design.
  • Project and Portfolio Management as a key tool to manage continuous improvement Mar 14 2018 2:00 pm UTC 75 mins
    Gloria Gadea-Lopez, Ph.D.and Melvin Santos
    Continuous improvement, risk mitigation and adherence to compliance rely on the successful execution of key initiatives aligned with an organization’s strategic imperatives. This article summarizes the Project and Portfolio initiatives at Shire’s Biologics manufacturing facility at Shire, Lexington, MA site. In addition to practical advice, the authors discuss the need for sound business processes, alignment with Finance and budget cycles, and play special attention to the importance of resource allocation and management.
  • Process analytical Technology for Upstream Bioprocessing Mar 5 2018 3:00 pm UTC 75 mins
    Erica Fratz-Berilla & LCDR Agarabi
    In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence (COE) in Manufacturing Science and Innovation, studies Process Analytical Technology (PAT) for upstream bioprocessing, focusing on the production of monoclonal antibodies. These capabilities are being leveraged to study continuous bioreactor cell culture production and compatible PAT tools. Case studies are presented that illustrate collaborative laboratory research being conducted on PAT tools for upstream bioprocessing to support regulatory decision making.
  • Environmental Monitoring Trend Analysis Tools Feb 28 2018 3:00 pm UTC 75 mins
    Steve Walton
    Qualitative analysis of environmental monitoring data is vital for pharmaceutical quality groups. Essential to identifying evolving microbial trends are the means to effectively parse and analyze EM results. To make the best use of the tools available, they must be used with a full understanding of their value and limitations. In this paper, the pros and cons of several EM trend analysis tools will be presented to aid microbiology experts to qualitatively evaluate EM performance data.
  • Efficient execution of biologics manufacturing – The role of Finite Scheduling Feb 14 2018 3:00 pm UTC 75 mins
    Gloria Gadea-Lopez, Ph.D., John Maguire and Gerry Glennon
    The success of manufacturing relies on the availability of all the resources –personnel, materials, equipment, work instructions - , orchestrated in such a way that the operations proceed in an efficient and predictable manner. This article describes the implementation of a finite scheduling system for biologics production, the foundational work required prior to project launch, lessons learned, and benefits achieved from this deployment.
  • Do Extractable Protocols Truly Help- An End User Perspective Feb 5 2018 3:00 pm UTC 75 mins
    Ekta Mahajan, Genentech/Roche
    Single Use technology is being used more each year in the biotechnology industry. However, extractables and their potential impact on product and patients continue to be one of the biggest challenges. The challenge is augmented by the lack of standardized methodology for suppliers to execute extractable studies that meets end user requirements. The end users are responsible and required by law to assess the impact of extractables and leachables on overall Product Quality and Safety. Due to lack of a standard, customized data had to be generated for/by each end users. This resulted in long lead times, higher costs and inefficient utilization of resources. Typically, the data generation and qualification of single use component can take up to a year, which can impact implementation of single use. BioPhorum Operations Group (BPOG) developed a standardized protocol9 for generating extractable data that would meet user requirements and simplify/reduce implementation time within industry. A standardized protocol gives confidence to suppliers that testing performed by them would meet end user requirements and enable faster implementation. Some suppliers shared the BPOG vision and proactively tested their single use components using BPOG protocol, which has helped expedite the use of their products.
  • Enabling comprehensive data analytics and process monitoring in Biomanufacturing Jan 17 2018 3:00 pm UTC 75 mins
    Robert Dimitri, Hugo Guerra and Gloria Gadea-Lopez, Ph. D
    Technical teams rely on the availability of meaningful data and effective tools to perform process monitoring, to conduct root cause analysis and investigations and, most of all, to obtain new insights into their operations. In this article, the authors discuss the implementation and management of a comprehensive system for data analytics at Shire –Lexington, MA site, the lessons learned, and practical advice towards the successful deployment of these key applications.
  • Current and future applications of Near-infrared in Pharmaceutical and Biopharma Jan 10 2018 3:00 pm UTC 75 mins
    Dr Erik Skibsted
    Nearinfrared has a long tradition as analytical technology in pharmaceutical industry. In this article/webinar new applications, technology and improvements in regulatory guidances will be presented which will support further growth of nearinfrared in the pharmaceutical and biopharmaceutical industry.
  • Approaches for Dissolution Prediction of Tablets made by Continuous Manufacturin Nov 21 2017 2:00 pm UTC 75 mins
    Pallavi Pawar
    Approaches for Dissolution Prediction of Tablets made by Continuous Manufacturing
  • Can the New generation of perfusion technology compete or replace the convention Nov 15 2017 10:00 am UTC 75 mins
    Ankur Bhatnagar
    Recently, there has been a renewed interest in the field of continuous processing. Some key factors driving this interest are – availability of better cell retention devices, improved cell lines and culture medium capable of supporting high cell densities.

    These factors have contributed mainly in reducing the batch duration for making the required quantity of product, thus reducing the medium requirement and chances of batch failures significantly. With the continuous processing being considered as ‘back-in-the-game’, the question remains: Can the current perfusion technology compete or replace the conventional and widely preferred fed-batch technology?

    Two cases are discussed to compare the performance features of fed-batch and perfusion processes. In both the cases, the product output from perfusion process is significantly higher (2 to 5 folds) than that from fed-batch, due to combination of factors like higher cell density, higher cell specific productivity, lower accumulation of toxic metabolites etc. These cases demonstrate the potential of perfusion process in significantly increasing the product output. However, there are certain challenges and points to be considered before a company decides to switch to a perfusion platform. Some of these are highlighted in the article.
  • Single-Use Stainless Steel BioReactors: Quality Factors for Consideration When S Nov 8 2017 3:00 pm UTC 75 mins
    Dr Trevor Deeks, Principal and Consultant of Deeks Pharmaceutical Consulting Services, LLC
    Single-use (SU) systems are now in common use in pharmaceutical bioprocessing, as well as in other related technologies such as the manufacture of diagnostics and other biological products, and their popularity is increasing. Some types of SU systems have been in use for many decades now. The earliest SU systems being disposable filter cartridges that do not require a stainless steel (SS) filter housing. This present article seeks to focus in particular on SU bioreactors for cell culture and bacterial fermentation for the purpose of producing therapeutic proteins, monoclonal antibodies and vaccines. SU bioreactors are of particular value in early phase (Clinical Phases 1 and 2) GMP manufacturing. In some cases their use has now stretched through into commercial processing, albeit that the scale of operation is currently limited and in general the largest commercially available SU bioreactors are around 2000L working volume (WV). However, the small footprint that they require, and the reduction in investment needed for support services and utilities, means that the scale limitations can be overcome to a significant degree by having multiple SU bioreactors operating in parallel within a facility. The harvest from multiple bioreactors can be pooled for downstream processing, or each harvest can be processed as a separate batch, based upon considerations of the risks versus the economies of pooling.
  • Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing Nov 1 2017 2:00 pm UTC 75 mins
    Dr Joachim Walter
    Since the introduction of disposables and gaining popularity of Single-use Technology (SUT) for biopharmaceutical manufacturing there is nevertheless an ongoing controversial discussion on the advantages and disadvantages versus a conventional stainless steel environment.

    In a “classical” facility design any validation cost effort can easily be distributed to a considerable number of production runs thus contributing only to a non-decisive amount to the overall production costs. The scale for such plant is nearly unlimited as is the scale of operation. The “flexible” approach using disposables and single-use equipment offers significant advantages regarding changeover work and time thus a high throughput of different processes will definitely take profit as any cleaning and related validation and costly analytics doesn’t apply to a larger extent.

    Despite the potential benefits loudly advertised by the respective industry, these potential advantages derived from single-use equipment and disposables can be significantly diminished by lack of detailed process cost analysis, missing economic analysis and cost comparison between conventional and SU technologies as well as underestimating the cost of long term dependency on consumables. Due to missing appropriate standards, there is a widely non-compatibility between the equipment and consumables of the various suppliers, resulting in a strong dependence on the consumables of a single supplier once a single-use equipment has been purchased, curiously leaving some customers with surprise that they hardly have any room for price negotiations on the required consumables.
    This paper’s focus is on the very different arguments for the application of SU equipment and consumables, including advantages and limitations of SUT, understanding improvement of process robustness, contribution to lean production as well as environmental impact of disposables.
  • Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Oct 31 2017 2:00 pm UTC 75 mins
    Dr Li Zang
    Common mammalian cell lines used for biopharmaceutical production include Chinese Hamster Ovary (CHO), NS0 and Human Embryonic Kidney (HEK) cells. Each of these cell lines has been found with over 20,000 genes coded in their genome, which can result in over 10,000 proteins expressed at the same time in these cells. These proteins can be secreted from the living host cells or released to the cell culture supernatant upon lysis of the host cells during the cell culture. Biopharmaceuticals produced using these cell lines can be co-purified with a subset of the host-cell proteins (HCPs) in the cell culture supernatant.

    These co-purified HCPs are considered process-related impurities for biopharmaceuticals. The HCPs can cause potential safety risks by introducing anti-HCP response in the patients. Depending on the biological functions of the residual HCPs, other potential impacts reported include lowering the biopharmaceutical protein stability and affecting the efficacy of the biopharmaceutical protein by exacerbating the symptoms.
  • The Future of Pharmaceutical Manufacturing: Flexibility and Sustainability throu Oct 10 2017 2:00 pm UTC 75 mins
    Daniel O. Blackwood & Jeffrey Moriarty of Pfizer, Inc.
    Following a decade (or more) of concerted effort by industry, regulator, and academic groups, recent technology investments are now beginning to shape how medicines are being developed and manufactured for the global marketplace. While significant focus has highlighted the emergence of continuous manufacturing processes, three additional trends have also influenced and served as underlying drivers for these technology investments. First, the emergence of scientific advances in targeted biology has created high-value personalized medicines with smaller manufacturing volumes (doses/annum). Second, new regulatory pathways, such as the FDA’s Breakthrough Therapy designation, have accelerated the development and commercialization timelines for these new medicines. Finally, manufacturing localization has extended supply chain networks to serve globally-distributed patient populations throughout the world. Together, these drivers have served to shape the future of pharmaceutical development, manufacturing, and distribution of a variety of different dosage forms. The increasing need for product development speed and commercial supply flexibility through small-footprint, modular equipment trains will be highlighted within this paper, using an immediate-release solid oral dosage form example.
  • Advances in Mass Spectrometry for the Analysis and Bioanalysis of Antibody-Drug Sep 12 2017 2:00 pm UTC 75 mins
    Arnaud Delobel, PhD
    ADCs are complex compounds resulting from the coupling of cytotoxic small molecules to a monoclonal antibody. Their characterization as well as their bioanalysis (quantification in biological fluids) remains challenging. Mass spectrometry at different levels (intact, middle, peptide) can be a valuable tool, and can now be used in a regulated environment thanks to advances in both hardware and software.
  • New Paradigm of Building Quality during Manufacture - Challenges with Biologics Recorded: Aug 23 2017 75 mins
    Dr Rajesh K. Gupta
    Historically, quality of biological products has been ensured through testing representative samples. Shift in quality paradigm started with implementation of Good Manufacturing Practice (GMP) regulations with current focus on building quality during manufacture. Inherent variability and complexity of biological products pose challenges in implementing Quality by design (QbD) concept. This presentation discusses ways to build quality during manufacture of biological products.
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  • Title: A risk based approach to continuous processing
  • Live at: May 14 2015 8:00 am
  • Presented by: Rob Bowen
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