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Top Stories
Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.
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The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.
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Industry News
NJII and Pall collaborate to address biomanufacturing technology and workforce development challenges.
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The partnership will enable the Applied Process Company (APC) and the National Institute for Bioprocessing Research & Training (NIBRT) to provide increased access to R&D and analytical services.
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Biopharma News
Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis' gene-therapy manufacturing capacity.
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XenTech and the Gustave Roussy Cancer Center have signed a collaboration agreement to develop a collection of tumor explant models from patients with acquired resistance to targeted therapies.
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Supplier News
The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.
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The BioContinuum Buffer Delivery Platform offers streamlined buffer management and delivers "contiGuous" bioprocessing.
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Advanced Lipid-Based Delivery Systems
ABITEC develops innovative techniques in the delivery of Active Pharmaceutical Ingredients (APIs). They continue to explore and advance into new and novel formulations that experience the most challenging issues around solubility, bioavailability, and permeability. With expertise in a range of dosage forms ABITEC delivers unique solutions across a range of applications in the pharmaceutical market.
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Regulatory News
From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.
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Novartis' Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.
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REGULATORY BEAT
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
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BIOPHARMACEUTICAL ANALYSIS
Fluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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CPhI NORTH AMERICA 2019 EXHIBITOR GUIDE
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BioPharma Solutions, a business unit of Baxter, collaborates with pharmaceutical companies to provide contract manufacturing form/fill/finish for sterile injectables.
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Catalent Biologics' Bloomington, Indiana facility provides sterile formulation and extensive biomanufacturing and drug product fill/finish capacity across a number of biological drug product formats.
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As a member of Eurofins Scientific's BioPharma Product Testing Group, Eurofins Lancaster Laboratories provides comprehensive laboratory services for the world's largest pharmaceutical and biopharmaceutical companies.
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EZ BioPac®–ILC Dover's EZ BioPac® single-use systems allow faster powder transfer and higher recovery rates.
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Lonza Pharma & Biotech provides global contract development and manufacturing services that enable pharma and biotech companies to bring medical innovations to patients in need.
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UPCOMING WEBCASTS
Characterizing CQAs of Biopharmaceutical Products: A Comprehensive Workflow Approach to Common Biopharmaceutical Tests
US and Europe: Wednesday, April 24, 2019 at 9am EDT | 2pm BST | 3pm CEST
US: Wednesday, April 24, 2019 at 2pm EDT | 1pm CDT | 11am PDT
Asia-Pacific: Thursday, April 25, 2019 at 8:30am IST | 11am CST | 12pm JST
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Approaches to Analyze and Understand 1–100 µm Particles/Aggregates in Biotherapeutics
Tuesday, April 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Direct Identification of Contaminant Particles on Lyophilization Cakes
Thursday, April 18, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Approaches to mAb Charge Variant Characterization using On-Line CEX-MS and Off-Line Analysis of CEX Purified Variants
Wednesday, April 17, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Meaningful Analytics Data for Quick Decision Making in Development of Viral Vector-Based Therapies
Wednesday, April 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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May 15–16, 2019
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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