CLINICAL SUPPLY MANUFACTURING ARTICLES
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.
CLINICAL SUPPLY MANUFACTURING VIDEOS
If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
CLINICAL SUPPLY MANUFACTURING RESOURCES
-
![Panademic Related Manufacturing Complications]( "Outsourcers Are Feeling Uneasy About Continuity Of Supply")
Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.
-
![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.
-
![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?
-
![GettyImages-1405217456 woman in lab]( "De-Risking Your Bioconjugate's Path To Clinical Manufacturing")
Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.
-
![iStock-136140244-lab-pharma-equipment-process]( "Speed To Market – API Large-Scale Commercial Manufacturing")
Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.
-
![WEST-ELAS LYO Lyotec-012 LREZ]( "Key Considerations For Selecting Fill/Finish Manufacturing Technologies")
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
-
![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
