CLINICAL SUPPLY MANUFACTURING ARTICLES
7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies
The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.
CLINICAL SUPPLY MANUFACTURING RESOURCES
-
Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.
-
Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
-
Handling development and manufacturing challenges for orphan drugs requires experience, expertise and scalable technologies, along with a flexible and agile supply chain.
-
As innovative, complex therapeutics advance toward clinical trials, properly handling, storing, and packaging temperature-sensitive critical materials is essential to maintain product integrity.
-
Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.
-
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.
-
Gain the knowledge and skills needed to effectively navigate the complex clinical supply distribution landscape within this important and rapidly growing region.