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          Tuesday January 14, 2020
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          BioProcess International

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          • Upstream
            Processing
            Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.
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          • Downstream
            Processing
            Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.
            • Filtration
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            • Viral Clearance
            • Chromatography
            • Downstream Contract Services
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          • Manufacturing
            Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.
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          • Analytical
            Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.
            • Culture Development
            • Cell Line Development
            • Downstream Development
            • Downstream Validation
            • Laboratory Equipment
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            Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.
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          Biosimilarity Assessments: The Totality of Evidence Framework

          SponsoredThis article describes biosimilarity assessment approach applicable to comparability of lifecycle assessments and compliant with the US FDA’s totality of evidence concept.

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          eBook: Bioreactor Scale-Up: From Pilot to Commercial Scale in the Modern Era

          This online exclusive reviews the science and technologies affecting upstream process development, with a focus on bioreactors and flow geometry.

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          Emerging Treatments for Spinal Cord Damage

          This article explains why nerves damaged by spinal cord injury don’t regenerate and explores emerging treatments for spinal cord damage.

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          Pfizer unveils biosimilar launch plans and shares view on US market

          Pfizer set out a busy programme of biosimilar launches in its Q3 call and shared its thoughts on challenges facing the US market.

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          CMC Considerations for Commercial-Ready ADC Manufacturing Processes to Enable Accelerated Timelines

          SponsoredAt the CPhI Theater in May 2019, Courtney Morgret, PhD, senior scientist at ABBVIE, shared some key CMC considerations for antibody-drug conjugate products.

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          Streamlined Serum-Free Adaptation of CHO-DG44 Cells: Using a Novel Chemically Defined Medium

          This article details a streamlined protocol for serum-free adaptation of CHO-DG44 cell lines from adherent, serum-supplemented culture to suspension culture in a fully defined chemical medium.

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          A Faster Solution to Hybridoma Screening

          SponsoredIn this special report ModiQuest Research applies Intellicyt? iQue technology in its hybridoma screening process. The iQue3 system expedites the discovery of antibodies through improved screening of antigen presentation during stable cell line generation, sera evaluation, and hybridoma selection.

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          Control of Protein A Column Loading During Continuous Antibody Production: A Technology Overview of Real-Time Titer Measurement Methods

          This technology review explores ways to control protein A column loading by using real-time titer measurement during continuous antibody production.

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          Ask the Expert Webcasts

          On-Demand Webcasts

          • GMP Flow Cytometry: Applications, Considerations and Challenges
          • China’s GMP Strategies: Dealing with Quality Management Issues, to Compete with the West

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          Upstream Processing

          Matrix: The Highly Automated Multibioreactor Solution That Fits to Your Bench Space, Bioprocessing Needs, and Budget

          Innovative Strategies for Cell Culture Media Preparation

          See all in Upstream Processing

          Downstream Processing

          Monoclonal Antibody Aggregate Polish and Viral Clearance Using Hydrophobic-Interaction Chromatography

          Adenovirus Downstream Process Intensification: Implementation of a Membrane Adsorber

          See all in Downstream Processing

          White Papers

          Why Characterizing Protein Stability Matters For Drug Development

          Ten important lessons the cell and gene therapy industry can take from the bioprocessing industry

          BioContinuum? Buffer Delivery Platform

          New Features for Single-Use Pumps in Biopharmaceutical Manufacturing

          Analytical Power Tools Open Upstream Bioprocessing Bottlenecks

          Streamlining the Antibody Discovery Workflow at ModiQuest Research

          Single-Use Systems: Globalization Best Practices and Technology Specifications

          A Strategy to Remove Formulation Development from the Critical Path During Biologics Development

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          Manufacturing

          eBook: Viral Vectors for Vaccines — A Virtual Conversation on Production and Analysis

          The Proof Is in the Data: Extractables and Leachables

          See all in Manufacturing

          Analytical

          Trends in Data Analytics As Organizations Undergo a Digital Transformation

          Detection and Clearance of Viruses in the Biopharmaceutical Industry

          See all in Analytical

          Posters

          High Titer Recombinant Lentivirus and Adeno-associated Virus Production for Therapeutic Applications

          New Approach for Qualifying Liquid Handling in Single-Use Bags

          Antibody Affinity Extraction Enables Identification of Host Cell Proteins by Mass Spectrometry

          Step-wise strategy to address process characterization and late phase development – toward the definition of a standardized approach

          Characterization and Lot Release Assays for Antibody Drug Conjugates

          Keeping Host Cell Protein ELISAs Covered

          Removal of Isoagglutinins from IVIG and Plasma Using Affinity Chromatography

          Expansion, Recovery and Characterization of hMSCs on Dissolvable Microcarriers for Bioprocess Applications

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          Webinars

          Best Practices for Aseptic Sampling from Stainless Process Equipment

          A CDMO’s Perspective on the Development of Bioprocesses for Clinical Manufacturing Success

          Case Study in Conducting Chemical Safety Assessments for Single- and Multi-Use Manufacturing Components

          Closed, Single-Use TFF Assembly Makes Performance-Leading TangenX Cassette Technologies Even Easier to Use

          Asahi Kasei Bioprocess’ Planova SU-VFC: Realizing Single-Use Technology in Virus Filtration

          Blue capsules on a white background

          Discover Capsugel Dry-Powder Inhalation Capsule Portfolio

          Aseptic Filling for Gene Therapies and Next-Generation Biologics Within Closed Robotic Workcells

          Accelerating Timelines by Integrating Cell Line Development and Manufacturing Programs

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          Trending

          • Manufacturing

            eBook: Viral Vectors for Vaccines — A Virtual Conversation on Production and Analysis

          • Manufacturing

            eBook: Biologics Stability — Lifecycle Management of Drug Products

          • Analytical

            Trends in Data Analytics As Organizations Undergo a Digital Transformation

          • Downstream Processing

            Monoclonal Antibody Aggregate Polish and Viral Clearance Using Hydrophobic-Interaction Chromatography

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