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BioPharma Asia Magazine

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  • Viral Safety by Design for Cell and Gene Therapy Products
    Viral Safety by Design for Cell and Gene Therapy Products
    Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS Recorded: May 24 2019 68 mins
    Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C&GT) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C&GT product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.
  • Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and C
    Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and C
    Dr. Michael J. Miller, President of Microbiology, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieux Recorded: May 23 2019 75 mins
    Full Title: Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products

    Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.
    This webinar will focus on recent regulatory policy changes, compendial recommendations and industry best practices for alternative approaches to sterility testing of gene and cell therapy products. A review of Ph. Eur. 2.6.27 (Microbiological Examination of Cell-Based Preparations), USP informational chapter (Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach), EU Guidelines on Good Manufacturing Practice Specific to ATMPs and FDA’s Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications will be provided.The information provided will be supported by case studies on selecting a relevant sterility test sample and an appropriate sample size for the release of gene and cell therapy products.
  • Characterization of Subvisible Particles in Protein and Viral Vaccines
    Characterization of Subvisible Particles in Protein and Viral Vaccines
    Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein Simple Recorded: May 21 2019 53 mins
    Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur

    The topic of this presentation is characterisation of visible and subvisible particles in protein and viral vaccine formulations. Visible and subvisible particles were found to be inherent to the product, and were analyzed by several methods including MFI, DLS and PALS.

    Followed by Characterizing Sub-Visible Particle Populations with Micro-Flow Imaging

    Presented by Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple

    Accurate determination of sub-visible particles and protein aggregates is important to ensure safety and efficacy of biopharmaceutical formulations. As such, biopharmaceutical manufacturers are expected to characterize, monitor, and control sub-visible particles and protein aggregates in their products. Traditional techniques such as light obscuration often lack the sensitivity to distinguish translucent and potentially harmful protein aggregates. With imaging-based, direct particle detection, Micro-Flow Imaging (MFI) offers several advantages over traditional techniques, enabling the ability to detect and identify protein aggregates as well as other sub-visible contaminants. In this presentation, we will discuss how MFI provides particle count, size, and other morphological information in order to provide novel and unique insights into particle characterization and quantification in protein formulations.
  • Do Extractable Protocols Truly Help- An End User Perspective
    Do Extractable Protocols Truly Help- An End User Perspective
    Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for E & L at Merck KGaA, Darmstadt Germany Recorded: May 8 2019 48 mins
    Presented by Ekta Mahajan, Technical Regulatory Program Director at Genentech

    Extractables and their perceived impact on product and patients continue to be a challenge. The challenge is augmented by the lack of standardized extractable data from suppliers. BioPhorum Operations Group (BPOG) developed a standardized protocol for generating extractable data that would meet user requirements. This paper will discuss case studies where data from a supplier using the BPOG protocol significantly reduced the time for implementation.

    Followed by Standardized protocols for generating extractables data on Filtration and Single Use Systems – An analytical perspective

    Presented by Dr. Saskia Haehn, Laboratory Manager for E & L at Central Analytics of Merck KGaA, Darmstadt Germany

    The Biopharmaceutical industry has always been aware of the risk of using disposable technology such as filters and Single use systems in their processes despite their several unique advantages. The ability to control and mitigate the risk from extractables and leachables to a product and the patient safety highly depends on the availability of the complete extractables profile for these products. In the recent years, tremendous efforts have been made towards standardization of the Extractables test methodology both from the perspective of using the right extraction methods and the enhancement of analytical techniques. This discussion will focus on the challenges and advantages using the various model solvent streams in the standardized test methods and their relative comparison. In addition, the focus would also be on the unknowns arising from the analysis using such model solvent streams.
  • Pharmaceutical Hot Melt Extrusion A Cost Effective Method to Increase Solubility
    Pharmaceutical Hot Melt Extrusion A Cost Effective Method to Increase Solubility
    Dennis Douroumis, of University of Greenwich and Dr.-Ing Margarethe Richter, Pharma Application Specialist at Thermo Fisher Recorded: May 7 2019 59 mins
    Full Title: Employing Hot Melt Extrusion As a Cost Effective Method of Increasing Solubility Of Water Insoluble API’s
    • Identifying the appropriate excipients for HME processing of water insoluble drugs
    • Using novel excipients to achieve increased dissolution rates (Granulation)
    • Extrusion with polymeric carriers for the development of solid dispersions
    • Co-crystallisation of water insoluble drugs

    In the last 20 years Hot Melt Extrusion (HME) has seized the attention of pharmaceutical industry for the development of pharmaceutical solid dispersions. It is a versatile processing technology, which can effectively increase the solubility/dissolution of water insoluble active pharmaceutical ingredients (APIs). The processing of a wide range of materials including inorganic excipients, hydrophilic polymers or cocrystal formers renders HME advantageous compared to conventional formulation technologies. In this review article we discuss recent trends for increased solubility/dissolution of water insoluble actives by using HME and predictive tools for process optimisation.

    As a well-known process in polymer industry hot melt extrusion (HME) is approaching pharmaceutical manufacturing. HME allows innovative formulations of solid oral dosage forms. Its main advantage in pharmaceutical applications is the possibility to enhance bioavailability of a drug, i.e. to produce solid dispersions of the active pharmaceutical ingredient (API) in the polymer matrix. The main concern of the formulator is to achieve the appropriate release profile (immediate or sustained release) or improved bioavailability of the API. The presentation gives an introduction into HME technology as an alternative to spray drying. It includes several case studies related to HME for solid oral dosage forms. In addition to solid oral dosage forms hot melt extrusion (HME) can be used for novel delivery methods. The presentation gives an overview on possible applications including examples and case studies.
  • PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry
    PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry
    Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Ro Recorded: May 3 2019 71 mins
    Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices commonly used for biologic formulations and certain therapeutic proteins. LER is defined as the inability to recover >50% activity over time when endotoxin is added to an undiluted product. LER is a temperature-and time dependent process, which usually does not occur immediately but after several hours to several days. Compendial LAL method qualification (Bacterial Endotoxin Test = BET per USP /EP 2.6.14/JP 4.01) does not include defined hold time conditions, which may explain why LER has not been detected by following compendial BET guidance. Because of the potential impact to patient safety and complex nature of the LER issue, the Parenteral Drug Association (PDA) published a Technical Report (TR) on LER. This TR was authored by subject matter experts from academia, U.S. FDA, biopharmaceutical companies, and reagent suppliers/testing contractors. The PDA Technical Report on Low Endotoxin Recovery provides a science-based and data-driven strategy in dealing with the LER phenomenon. The author of this article, who acted as co-lead of the TR authoring team, provides first hand information that allows companies to develop product specific solutions to the LER problem.
  • Analysing Complex Data in the Pharmaceutical Industry: The Case for Multivariate
    Analysing Complex Data in the Pharmaceutical Industry: The Case for Multivariate
    Mike Tobyn, Research Fellow at Bristol-Myers Squibb Recorded: May 2 2019 50 mins
    The Pharmaceutical Industry has a strong need to develop knowledge from data. Although the latter is not at a premium in the Pharmaceutical Industry the former is, as always, at a premium. Multivariate data analysis (MVA) is a set of statistical data analytical methods which has  been widely adopted within the Pharmaceutical Industry, and it has pre-eminence within the discipline.

    The ability of MVA to provide validatable solutions within a Regulated Pharmaceutical environment has arisen because of its transparency and reproducibility, across a wide field of data sources. An ecosystem of software providers, allied with hardware solutions, means that the  techniques are becoming widely understood and applied.

    Key to this adoption has been the ability of MVA techniques to meet not only direct Regulatory Guidance, but also Industry Standards such as ICH Q8 and initiatives such as Quality by Design.

    A wide body of literature is now available which explains how to use the technique appropriately, so that these Guidances can be met, leading to robust solutions
  • Applying Low Frequency Raman to QbD in Pharmaceutical Development
    Applying Low Frequency Raman to QbD in Pharmaceutical Development
    John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb and James Carriere, Product Line Manager at Coherent Recorded: Apr 26 2019 65 mins
    Low frequency Raman spectroscopy has been used to study various polymorphs and can be applied to the design of crystallization control strategy. Extending the low frequency spectral region to include the fingerprint region, provides access to collective vibrations of molecules in the amorphous and crystalline states and yields valuable insight when differentiation of various forms is quintessential. Whether during process development or production, low frequency Raman bands provide greater sensitivity for detecting the onset of crystallization and has allowed differentiation of crystal types when multiple forms are possible. Applying this to Quality by Design (QbD) studies brings an increase in process understanding leading to developing optimal control strategy and avoid the many pitfalls that can occur when scaled-up to the production environment. A recent applications of in-line crystallization processes provided insight into establishing the ideal crystallization control parameters. The parameters evaluated include temperature, mixing rate, seed levels and solvent variable. In-line and off-line QbD studies demonstrated both ideal and non-ideal conditions, ultimately yielding critical process knowledge. As a results of our studies, low frequency Raman has proven to be a valuable tool for at-line and on-line monitoring of active pharmaceutical ingredient crystallization and paves the way for robust production in a large scale facility.
  • New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical...
    New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical...
    Presented by Friedrich von Wintzingerode Global QC at Roche Followed by Mathilde Arnault, Research Scientist at Merck KGaA, Recorded: Apr 9 2019 62 mins
    Full Title: New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process

    Large scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic or inflammatory responses in humans.

    Monocyte Activation Test: a powerful tool to assess pyrogenic risk in pharmaceutical process

    Microbial risk in pharmaceutical process is not limited to viable microorganisms. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps. According to the European Pharmacopeia, chapter 5.1.10, a risk assessment has to be performed to justify the method to be used for pyrogen detection: bacterial endotoxin testing is not sufficient if the presence of non-endotoxin pyrogens in the production process cannot be excluded.The Monocyte Activation Test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one test. Supported by many regulatory bodies, the robust MAT assay provides sensitive results based on the human immune reaction and can be a powerful
  • Introducing Chromassette®, a modular chromatography platform enabling next-gener
    Introducing Chromassette®, a modular chromatography platform enabling next-gener
    Ping Huang, Director, Head of DS BioProcesses, OED, Abbvie at Redwood and Masayoshi Nagaya, Sr. Global Technology Manager Recorded: Apr 5 2019 48 mins
    Title: Introducing Chromassette®, a modular chromatography platform enabling next-generation bioprocess purification.

    We will introduce Chromassette® and an application example of an integrated rapid single pass process from harvest to purified bulk, a concept demonstrated by AbbVie. Chromassette is a stackable, single-use and pre-packed chromatography cassette with a supported bed, addressing the current key challenges in manufacturing. Chromassette enhances the separation capabilities of chromatography resins and combines it with the convenience of a modular cassette.

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