CLINICAL SUPPLY MANUFACTURING ARTICLES
Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs
This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process.
CLINICAL SUPPLY MANUFACTURING VIDEOS
See how a cutting-edge, multi-purpose isolator line delivers high-speed, precision fill/finish. This flexible technology supports a diverse range injectable therapies.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
Susan Dexter, Chief Technical Officer, Sonnet BioTherapeutics, describes the good choices she made, and one not-so-good choice, in trying to untie a knotted supply chain.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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![pharma-success-GettyImages-2217587867]( "Why Advanced cGMP Manufacturing Is Key to Pharma Success")
Advanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.
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![Microscope of cell, Embryonic stem cell]( "Optimizing Autologous Cell Therapy Clinical Trials")
Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.
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![Vaccine Manufacturing GettyImages-1384850913]( "GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm")
Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.
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![cdmo-drug-assembly-manual-GettyImages-1339603591]( "Practical Playbook For The Manual Assembly Of Combination Products")
Manual assembly plays a vital role in early‑phase combination product development. Learn how strong process design, collaboration, and quality controls help teams reduce risk, improve consistency, and move confidently toward later‑stage manufacturing.
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![BO 2 - GC_App_^CZ vial with stopper and seal stack up]( "Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization")
While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
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![iStock-1293772969-lab-microscope-scientist-research]( "Clinical Manufacturing: What It Is And How It Works")
Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?
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![GettyImages-1189150676-Medicinal_Marijuana_Cannabis_ControlledSubstance]( "Controlled Substances In Clinical Trials")
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
