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Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development ServicesOutsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development ServicesOutsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services Get more pharma outsourcing insight with our FREE newsletter sign me up Log In or Subscribe Find A Partner Bioanalytical Services Biologic API Biologic Drug Product Cell & Gene Clinical Supply Fill/Finish Small Molecule API Small Molecule Drug Product Development Contract Manufacturing Packaging Logistics Events Outsourced Pharma Capacity Update Outsourced Pharma Live CDMO Leadership Awards FEATURED EDITORIAL Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals BIOSECURE Act Passes House. How Will It Impact Your Outsourcing? How To Leverage Platform And Process Characterization Data To Accelerate Cell & Gene Therapies Warning To U.S.-Based CDMOs: Don't Get Complacent Wish SUS Cost Less? Survey Says Your Peers Do, Too Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR EMA Issues New Draft Guideline: Chemistry Of Active Substances The CDMO Chase Has Gone Digital. Is It Safe? August 2024 — CDMO Opportunities And Threats Report GUEST COLUMNISTS Wish SUS Cost Less? Survey Says Your Peers Do, Too BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area. Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR Content uniformity is one of the most important release criteria for solid dosage forms. In continuous manufacturing, what process analytical technologies (PAT) are available to measure and assure content uniformity as part of a real time release (RTR) strategy? EMA Issues New Draft Guideline: Chemistry Of Active Substances The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025. August 2024 — CDMO Opportunities And Threats Report Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections. Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake Disposable probes and sensors offer advantages over their reusable counterparts, especially as industry moves toward flexible, scalable production models. A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster. Great siRNA Science Or Savvy Business Acumen? You Need Both Silence Therapeutics has two wholly owned siRNA therapies now in clinical trials and one partnered program with AstraZeneca. Silence's CEO discusses the need for good science, making smart business decisions, and cultivating partnerships. Luxturna Maker Spark Therapeutics' Flexible Platform Approach The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss. More From Guest Columnists PHARMA OUTSOURCING WHITE PAPERS Validating The Efficacy Of A Compound With Spatial Imaging Discover how target and efficacy validation can translate into substantial savings and market advantages for sponsors as a result of shortened development and approval timelines. Sterile Filtration And Quality Risk Management Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies. Inspecting On The Edge — Understanding Punch Tip Wear Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear? Reducing ADC Timelines With Integrated Development And Manufacturing Services ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently. Establishing Commercial Manufacturing Services For ADCs Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities. Recommendations For Successful IND Approval Of RNA-LNP Drugs The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines. More Pharma Outsourcing White Papers PHARMA OUTSOURCING APP NOTES & CASE STUDIES A Synergy Of Excellence: Partnership During Unprecedented Times Industry-Leading Advanced Therapy Support Revolutionizing Transport Implementing A Disaster Recovery Plan Accurate Cell Culture Characterization Next Generation Sequencing For Adventitious Agent Detection In Cell Banks More Pharma Outsourcing App Notes & Case Studies NEWSLETTER ARCHIVE 09.13.24 -- All Eyes On Sustainability 09.13.24 -- BIOSECURE Act Passes House. How Will It Impact Your Outsourcing? 09.12.24 -- Development Approaches To Meet The Unique Needs Of Pediatric Populations 09.12.24 -- Get The Most Out Of Your Filtration Processes More Newsletters BIOSECURE Act Passes House. How Will It Impact Your Outsourcing? Warning To U.S.-Based CDMOs: Don't Get Complacent The CDMO Chase Has Gone Digital. Is It Safe? The High Life And Times Of A Qualified Person (QP) In Europe Clinical Trials In China Reboot BIOSECURE Act More From Chief Editor Louis Garguilo REPORTING: U.S. BIOSECURE ACT BIOSECURE Act Passes House. How Will It Impact Your Outsourcing? Warning To U.S.-Based CDMOs: Don't Get Complacent Clinical Trials In China Reboot BIOSECURE Act Breaking: BIOSECURE Act Out. Long Live Wuxi Apptec? Assassination By Implication? Interview With WuXi AppTec (Part 2) Exclusive Interview: WuXi AppTec Responds To BIOSECURE Act Nothing To See Here! Just Big Pharma Investments In China You Want To Rein In China? Then Actually Do It From Ally To Adversary: BIO's Swift Rebuke Of WuXi BIO Expels WuXi, Agrees With U.S. Government Newsletter Signup Get the latest articles from Outsourced Pharma delivered to your inbox. I agree to the Terms. I agree to the Privacy Statement. SIGN ME UP CONTENT COLLECTIONS   A great resource to help you find and evaluate the best CDMOs in the world. Included in this CDMO Leadership Awards issue are some insightful articles on development and manufacturing outsourcing. More Content Collections PRODUCTS & SERVICES Manufacturing, Science, And Technologies (MS&T): Translating Breakthrough Medicines From The Bench To The Clinic A Revolutionary Platform To Simplify Column Handling At All Scales Cell Line Development Packaging QP Services Process Development Product Labeling And Kitting Services Scale Your Vaccine With Path-To-PAD Comprehensive And Flexible Cell Therapy Manufacturing More Products & Services ON-DEMAND WEBINARS Advances In Oral GLP-1 Analogs For Obesity Navigating Challenges During Formulation Development Formulation Considerations For The Development Of High Concentration Biopharmaceuticals New Data: NanoImprove Bioavailability, Drug Loads, And Pill Burdens Of Your Solid Dispersions Intensifying Downstream Bioprocessing With Continuous Technologies More On-Demand Webinars INDUSTRY NEWS Lilly Expands Manufacturing Footprint In Ireland With $1.8B Investment Cellares And Sony Announce A Joint Development Collaboration To Integrate Flow Cytometry-Based Sorting And Online Analysis Into An Automated, High-Throughput Cell Therapy Manufacturing Platform Cellular Origins And 3P Innovation Collaborate To Accelerate Industrialisation Of CGT Manufacturing PharmAla To Supply Johns Hopkins Medicine For Clinical Trial AGC And MEDINET Sign Strategic Partnership Agreement For Cell Therapy CDMO Business Merck Launches Single-Use Reactor Designed To Accelerate Antibody Drug Conjugate Manufacturing Osivax And KM Biologics Enter Exclusive License Option Agreement For Broad-Spectrum 'Universal' Influenza Vaccine In Japan Evonik Starts Operation Of New Spray Drying Facility For Pharmaceutical Oral Excipients Serán More Than Doubles Clinical Manufacturing Capacity In Bend, Oregon Serán More Than Doubles Clinical Manufacturing Capacity In Bend, Oregon Hongene Biotech Corporation And ReciBioPharm Establish A Gene Editing Development Partnership Scantox Group Acquires Gentronix, A World Leader In Genetic Toxicology Somite Therapeutics And OmniaBio Inc. Announce Collaboration To Advance Somite's Cell Therapy Flagship Program Muscular Dystrophy Association And Forge Biologics Announce AAV Development And Manufacturing Partnership More Industry News This website uses cookies to ensure you get the best experience on our website. Learn more Got it! Partner With Us Request More Information Our Partners Subscribe Newsletter Follow Us on LinkedIn Life Science Connect Advancing RNA Bioprocess Online Biosimilar Development Cell & Gene Clinical Leader Clinical Supply Leader Clinical Tech Leader Drug Delivery Leader Drug Discovery Laboratory Network Life Science Leader Med Device Online Pharmaceutical Online Editorial Archived Newsletters Article Reprints Editorial Submission Guidelines Editorial Advisory Board The Expert Network Events CMO Leadership Awards CRO Leadership Awards Learn More About Us Contact Us Work For Us Copyright © 1996-2024 VertMarkets, Inc. All Rights Reserved. Terms of Use. Privacy Statement. Subscriber Request Form. 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