DOWNSTREAM PROCESSING FEATURED ARTICLES
Taiho Pharmaceutical Co., Ltd. announced on May 31 that a global Phase III clinical trial (RECOURSE) for the novel combination antimetabolite TAS-102 will start in June this year.
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Lonza And OncoMed Pharmaceuticals Sign A Process Development And Manufacturing Collaboration And Multi-Product GS License Agreement For Anti-Cancer Therapeutics
Lonza, a global leader in biological manufacturing and OncoMed Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to improving cancer treatment, announced recently an agreement for the development and manufacture of OncoMed’s pipeline of anti-cancer stem cell therapeutics.
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![bert_headshot]( "Abcentra Chief Looks Beyond The Clinical Horizon")
Abcentra Chief Looks Beyond The Clinical HorizonWhy Bert Liang, M.D., Ph.D. obsesses over at-scale manufacturing and regulatory challenges from the outset of clinical trials.
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NeoStem's Subsidiary, Progenitor Cell Therapy, Enters Into A Cell Therapy Manufacturing Services Agreement With Adaptimmune
NeoStem, Inc. and its subsidiary, Progenitor Cell Therapy LLC ("PCT"), together with Adaptimmune Limited and Adaptimmune LLC (collectively, "Adaptimmune"), announced recently a Services Agreement under which PCT will provide services to support Adaptimmune's NYESO-1c259-T cell therapy product being developed for multiple oncology indications (for more information with respect to Adaptimmune's clinical trials, see clinicaltrials.gov, identifiers NCT01350401, NCT01343043 and NCT01352286).
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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An Automated Profiling Application For G9a Histone Methyltransferase And Bromodomain Proteins
Due to several findings, G9a and BET bromodomain proteins have become the target for numberous drug discovery projects. In this study, we describe a novel, cell-based assay platform that uses the robust, yet simple Enzyme Fragment Complementation (EFC) Technology.
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Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
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Sani-Tech® Ultra White Paper
For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.
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Turning Data Into Information
As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.
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Proven Long Life Lasers™ In Optical Particle Counters Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.
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![CPC AQ variety (feature)]( "Single-Use Connections Advance Aseptic Processing")
Single-Use Connections Advance Aseptic ProcessingJohn Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.
DOWNSTREAM PROCESSING PRODUCTS
Storage of pharmaceutical compounds is a function of the storage process and not a specific containment driven requirement per se. This is the case whether you are processing in a contained fashion or performing non-contained processing into open kegs with simple drum liners.
CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.
DOWNSTREAM PROCESSING MULTIMEDIA
Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.
Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.