Commercially Successful Cell Therapies : Navigating the Ultra Cold Chain Distribution Minefield
If you have a cell-based therapy in development, then you need to consider such variables as packaging, storage, inventory management, monitoring systems, distribution, and even clinical site capabilities well before you begin to prepare the Investigational New Drug (IND) submission to the Food and Drug Administration (FDA). By sidestepping these issues until clinical trials begin, you may discover late in the game that you have inadvertently limited your product’s scalability and commercial viability, incurred unnecessary costs and complications downstream, and failed to meet FDA criteria for documentation of cold chain and chain of custody requirements.
Topic: Cold-Chain Logistics, Content: eBook
Defense in Depth: Off-Site Storage for Biological Specimens and Biopharmaceuticals Risk Mitigation
The management of risk is part of all business operations, but to biotech companies manufacturing cell-based therapies, risk mitigation is necessarily a critical element of day-to-day operations. The costly nature of irreplaceable samples/cell lines and high value products such as cell-based drugs, and biological active pharmaceutical ingredient (Bio-API) dictates planning for the full continuum of risk. The best solution is frequently offsite storage.
Content: eBook, Topic: Biobanking and Biorepositor..........
Biobank: Should You Build Your Own or Outsource?
Are you involved in continuing discussions about the need for finding biomarkers and improving translational research? At the core of biomarker development is the global healthcare movement towards personalized Companion Diagnostics (CDx), in which clinicians and doctors will be able to identify the patients most likely to benefit from a particular drug or biologic, and also help determine risk of an adverse drug reaction from a particular therapeutic agent. While biobanking sits at the heart of biomarker development, the key to quality and sound discoveries is quality management of the biospecimens from the very beginning. From my recent participation in biobanking discussions I’ve heard growing concern over the quality of the biospecimens available and the reliability of research into potential biomarkers.
Topic: Biobanking and Biorepository, Content: eBoo..........