Records Management
PRODUCTS
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What is included in Forge's DMF?
DMFs come in all shapes and sizes, but Forge's DMF includes the following components:
- Information on our critical raw materials, including our Ignition Cells™ and pEMBR™ adenovirus helper plasmid
- An overview of our platform AAV manufacturing process
- Process controls
- Facility layout and engineering information
- And more!
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Getting a novel therapy through the clinical development process to approval is complicated. Unearth how to advance novel medical therapies from Phase I-III clinical development to market with confidence.
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Navigating the technical challenges of mAbs production and scalability
Monoclonal antibodies (mAbs) offer promising immunotherapy treatments, targeting antigens and diseases. Manufacturing these complex therapies presents challenges in scaling up, cost, and consistency. Germfree’s expertise in tailored cleanroom solutions addresses these obstacles, ensuring sterility and seamless equipment integration. By providing advanced facilities for both small-scale clinical trials and larger-scale production, Germfree contributes to the successful development and commercialization of mAbs, ultimately improving patient outcomes and transforming healthcare landscapes.
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AGC Biologics’ quality organization provides a comprehensive suite of Quality Assurance (QA) and Quality Control (QC) services. At each of our manufacturing facilities, highly trained Quality Units maintain strict quality systems to support our cGMP manufacturing efforts and to ensure compliance with all regulatory requirements.
WHITE PAPERS AND CASE STUDIES
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The City Of Fayetteville's Flood Resiliency In The Face Of Climate Change: Mapping 15 Watersheds
The city of Fayetteville, North Carolina has always had flooding issues, but it’s been getting worse as weather patterns have been changing. They were hit four years in a row by storms Matthew (2016), Irma (2017), Florence (2018), and Dorian (2019).
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The Latest Asset Management Software Helps Seattle Public Utilities Plan Ahead
SPU is forward thinking, with a desire to be more proactive in their pipe inspection rather than reactive with emergency response. Through a concerted effort, SPU developed a strategy for pipe inspection, condition evaluation, risk assessment, capital investment, and implementation planning.
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Risk Assessment As A Process Quality Assurance Tool
Discover how an effective approach to risk management can further ensure the delivery of a high-quality drug or medicine to the patient.
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PlantPAx Distributed Control System Reduces Downtime For Mallinckrodt
Learn how the nation's leading supplier in prescription pain medication completely upgraded their control system, resulting in greater diagnostic/troubleshooting information and reducing downtime.
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Successfully Creating Master & Working Cell Banks And Drug Product
Implementing Corning HYPERStack-36 vessels allowed Waisman Biomanufacturing to provide CMO services to biotech clients within difficult timelines and improve their COGS.
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Hillshire Brands Uses Manufacturing Intelligence
Explore solutions utilized by the Jimmy Dean brand, part of the Hillshire Brands portfolio, to address weight variance in one-pound sausage rolls that was driving up product giveaway and lost revenue.
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Go Digital, But Make It Effortless: Pharma Recipe Authoring
Explore some of the most commonly encountered challenges associated with recipe development and how going digital enables companies to turn molecules into medicine in a fraction of the time.
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Osmolality: A Powerful Tool In Bioprocessing
Learn more about the broad range of applications for osmolality testing and why it is crucial for process development, analytical development, and GMP testing.
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Clinical Supply Optimization: Process Improvement Accelerates Trials
A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.
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How Newark’s Lead Pipe Replacement Program Sparked The Creation Of leadCAST
Learn about how helping Newark digitize their lead pipe replacement program served as the foundation for leadCAST, a cloud-based management system for Lead & Copper Rule program management.
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Five Essentials For Accurate Oligonucleotide Chemistry
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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A High-Speed Look At Additive Manufacturing
In this case study, we look at how a Phantom high-speed camera enabled researchers to better understand the laser-matter interaction in additive manufacturing processes.
NEWS
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Meet 'Coscientist,' Your AI Lab Partner12/20/2023
In less time than it will take you to read this article, an artificial intelligence-driven system was able to autonomously learn about certain Nobel Prize-winning chemical reactions and design a successful laboratory procedure to make them. The AI did all that in just a few minutes — and nailed it on the first try.
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Unlocking Photonic Computing Power With Artificial 'Life'6/6/2023
The never-ending quest for faster, smaller computers that can do more has led manufacturers to design ever tinier transistors that are now packed into computer chips by the tens of billions.
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Carollo Engineers Honored With Three National Safety Council Awards For Exceptional Occupational Safety Practices8/1/2023
Carollo Engineers, the leading water engineering and consulting firm in North America, is proud to announce its receipt of three distinguished accolades from National Safety Council (NSC): the Perfect Record Award, the Occupational Excellence Achievement Award, and the Industry Leader Award.
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Study Unlocks Nanoscale Secrets For Designing Next-Generation Solar Cells2/28/2024
Perovskites, a broad class of compounds with a particular kind of crystal structure, have long been seen as a promising alternative or supplement to today’s silicon or cadmium telluride solar panels.
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A Motion Freezer For Particles2/28/2023
Tailor-made laser light fields can be used to slow down the movement of several particles and thus cool them down to extremely low temperatures - as shown by a team from TU Wien.