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NIR In-Line Monitoring for Drug Product Continuous Process: From Understanding t

During the past decade, continuous processing has steadily gained traction within pharmaceutical industry. The smaller footprint, the reduction or minimization of technology transfer and overall flexibility of these systems generate the economic drivers for change. The advancement of technology, such as integration of process equipment and process analytical technology (PAT) enables concentrated process understanding and effective process control for these systems. There are an increasing number of joint efforts from industries, academia and regulatory agencies in this area. Continuous manufacturing implementations for commercial products are beginning to emerge as companies begin to turned this vision into reality.
Among all the process analyzers, NIR is still one of the most widely used platform PAT tools in continuous processes. Some critical aspects should be considered for NIR (or other common PAT tools) implementation in continuous processes.
Recorded Jan 19 2016 59 mins
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Presented by
Yang (Angela) Liu
Presentation preview: NIR In-Line Monitoring for Drug Product Continuous Process: From Understanding t
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  • Functional collaborations required to successfully validate a Mab process at a C Feb 28 2018 3:00 pm UTC 75 mins
    Harish Santhanam
    Technology transfer leading to a successful validation of a Monoclonal Antibody process at a CMO site is a complex task that would need seamless interaction between various functions of the sending and receiving organizations. The success of the process is very much dependent on the technical depth, personal trust and the strength of the relationships established between the team members across the various functions in both organizations. The interactions begin with the due diligence process and builds through laboratory scale technology transfer leading to engineering/GMP campaigns and ends with a successful validation.  Depending on the stage in development of the molecule being technology transferred, the sending organizations could have personnel involved from both development and manufacturing making the process more complex. This write up will outline the role played by the various functions starting from Technical Services to Quality Assurance and will include functions like Shipping and Supply Chain.
  • 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.
  • Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing Jan 24 2018 3:00 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.
  • 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.
  • Towards Real Time Release testing: Dissolution prediction of tablets made using Jan 10 2018 3:00 pm UTC 75 mins
    Dr Erik Skibsted
    After 50 years of near-stagnation, pharmaceutical manufacturing is experiencing unprecedented scientific and technological innovation. There is a paradigm shift from testing product quality using lengthy off-line (and after-the-fact) assays to quality being tested during the process using online/ at-line measurements. This ability to evaluate and ensure quality of final product based on process data, geared towards making batch release decisions, is known as real time release testing (RTRt). A case study for predicting dissolution profiles of tablets made using CDC is presented. The methodology enables real-time release testing. Four different parameters were varied in the CDC line; API concentration, blender speed, feed frame speed, and compaction force, and their effect on tablet dissolution was investigated. Model dependent and model independent approaches were used to extract information from dissolution profiles. Multivariate regression was built between the information obtained from the NIR as the predictor variables and the dissolution profile parameters as the response. This enabled prediction of dissolution profiles for test samples made using CDC. Alternative RTRt approaches towards dissolution prediction will also be discussed.
  • Approaches for Dissolution Prediction of Tablets made by Continuous Manufacturin Recorded: Nov 21 2017 48 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 Recorded: Nov 15 2017 76 mins
    Ankur Bhatnagar & John Bonham-Carter
    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 Recorded: Nov 8 2017 76 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.
  • Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Recorded: Oct 31 2017 60 mins
    Dr Li Zang, Dr Chongfeng Xu and Dr Stephen Tate
    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 Recorded: Oct 10 2017 68 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 Recorded: Sep 12 2017 34 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.
  • Modernizing Biopharmaceutical Manufacturing: From Batch to Continuous Production Recorded: Jul 19 2017 66 mins
    Dr Robert Dream & Dr Peter Levison
    The importance and value of continuous bioprocessing, both upstream and downstream has economic and sustainability advantages and due to the modular nature of continuous bioprocesses means that industry is able to adapt more rapidly to changing market demands. Continuous biopharmaceutical manufacturing in the context of other industries that have already successfully adopted continuous processing. Factor other than scientific ones, are the barriers to change from batch to continuous production. an excellent example of the manufacturing strategies of the steel industry in the 20th century, when this industrial sector incrementally switched from batch to continuous operations. biopharmaceutical industry has reached a stage that requires a change in the production paradigm. For a certain class of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in the culture broth. In order to obtain a high quality product, the residence time in the reactor must be minimized. This can only be achieved with continuous cultivation and preferably with perfusion reactors. a brief overview on the types of cell retention devices currently used in biopharmaceutical industry.
    Furthermore, this is a universal production platform that can be extended to other classes of products, such as antibodies, which are relatively stable molecules. continuous manufacturing is as productive and with a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. In essence, the investment for a continuous plant is much smaller compared to a batch-operated one.
  • Implementing Single-Use PAT at seed stage to simplify cell culture operations Recorded: May 24 2017 35 mins
    Dr Jose R. Vallejos
    Single-Use Process Analytical Technologies (PAT) tools have a great potential to not only increase process understanding at the seed stage but also simplify cell culture operations. By utilizing PAT, the risk from bioburden or contamination can be significantly reduced and the overall operating efficiency increased. In fact, PAT also provides a data-driven platform to integrate Process Development and Manufacturing Operations that can mitigate risks associated with technology/process transfer.
  • Developing Practical Single-Use Processes for New Vaccine Formulations Recorded: May 16 2017 76 mins
    Kirsten Strahlendorf
    New vaccine process designs – and all the kinks that go with them – are typically hammered out in a small scale capacity, for example, prior to manufacturing for early phase human clinical trials. They are then upsized and further defined for industrial scale to supply the vast market. Single-use technologies (SUTs) have been a hot topic for several years now and their advantages well-known: easy product changeover, processing in lower classification areas, reduced CAPEX, elimination of glass, sterility assurance, to name a few. In vaccine manufacturing, SUTs are used throughout the processing stages, from cell culture all the way to filling. SUTs are quickly and conveniently designed, purchased and implemented for short-term manufacturing of clinical trial phase materials. Here a large percentage of new vaccines in Research and Development do not even make it to market.

    As the final production stages are critical as they are the last stages before patient injection, the scope of thisarticle covers SU applications involving drug substance formulations, adjuvant processing, final bulk formulation and filling. The actual process itself may include some or all of the following: filtration, pumping, ingredient addition, mixing, adsorption, filling, labelling, sampling and and storage.

    In this presentation only liquid formulations (“presentations”) will be discussed.
  • Single Use Systems in Biologics Manufacturing & their Impact on Operational Tech Recorded: Apr 4 2017 62 mins
    Gloria Gadea-Lopez, John Maguire, Mark Maselli & Ken Clapp
    The increased interest and adoption of single use systems (SUS) or disposables require that organizations rethink their operational business processes and the design and configuration of manufacturing execution systems (MES). Drawing from their previous experience implementing MES and SUS for biologics manufacturing, the authors discuss the key areas of impact of SUS on operational technology, outline new user requirements, and propose practical solutions for successful MES implementation.
  • Analytical Strategies for Comparability in Bioprocess Development Recorded: Mar 28 2017 71 mins
    Christine P. Chan, Ph.D & Joe Barco, Ph.D.
    Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the product remains highly similar (not necessarily identical) before and after the change in terms of quality and stability and have no adverse impact on safety and efficacy predicted for the patients. This assessment requires product-specific knowledge gathered through drug development, taking a totality-of-evidence approach. The different levels of information are obtained from analytical studies for characterization of the molecule, animal studies for toxicity, pharmacokinetics and pharmacodynamics for pharmacological activities, and clinical studies for safety/tolerability, immunogenicity and efficacy. This Webinar discusses strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration.

    Sponsored by Unchained Labs

    Presentation Title: Limber up your lab with better tools for comparing biologics

    There’s no magic bullet when it comes to characterizing a protein by structure or function. Specific tests may work for one molecule but not the next. Instrumentation that provides a high degree of flexibility, balanced with low sample consumption and faster time to result, is crucial to keep up with ever changing laboratory needs. Unchained Labs puts biologics characterization front and center for our instrumentation development. We will discuss how our instruments let researchers be more flexible and efficient, while also providing clear data to help make comparability assessments.
  • Subvisible Particle Identification & Characterisation by Multi-Technique Methods Recorded: Feb 23 2017 61 mins
    Dr Jonas Hoeg Thygesen & Colin Merrifield
    Observable foreign and particulate matter has for a long time been recognized as a critical quality attribute for production of injectable protein formulations. Recently, a focus shift towards these particles and even smaller particles (particulate matter or subvisible particles) has been seen from the pharmaceutical industry, academia and the different regulatory bodies. Two of the central documents in this context are:

    1. The FDA Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products1 and

    2. United States Pharmacopia Chapter 2
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