Biobanking for Animal Health: Morris Animal Foundation is Taking Veterinary Research to a New Level

The Morris Animal Foundation is working with Fisher BioServices and several other partners to take veterinary research—specifically, research into canine cancer—beyond the laboratory. Called the Golden Retriever Lifetime Study, the project is the first study to go into operation under the administrative umbrella of the Foundation’s Canine Lifetime Health Project (CLHP). The Golden Retriever Lifetime Study will enroll 3,000 dogs before age two, and collect environmental and other data as well as biospecimens, throughout the dogs’ life.

Topic: Biobanking and Biorepository, Content: eBoo..........

Cold Chain Qualification : 5 Questions You Must Ask When Shipping Biologics

“Cold Chain” refers to the undisrupted series of logistical activities (packaging, shipping, storage, distribution, handling) of products that must be maintained within a given temperature range. And as those of us in the biopharmaceutical industry know well, maintaining cold chain is critical to the integrity of biologically derived therapeutic products.

Topic: Qualification / Validation, Content: eBook

QP Essentials : Your EU Gateway to Clinical and Commercial Distribution of Cell Therapeutics

QPs—Qualified Persons–serve as the eyes and ears of the UK Medicines and Healthcare product Regulatory Agency (MHRA). Their primary focus is to protect patients by ensuring that medicinal products have been manufactured and handled according to GMP and European Union regulations. By protecting the patient, QPs also serve to help and protect the manufacturer.

Content: eBook, Topic: GMP Biologics Management

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.

Topic: Biobanking and Biorepository, Content: eBoo..........

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..........