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The State of Industry Tierney PDF
The State of Industry Tierney PDF
of the Industry
What is a biopharmaceutical?
Microorganism
Plant cells
Animal cells
Biologics
Examples include:
Monoclonal antibodies
Vaccines/theraputic vaccines
Blood and blood products
Gene therapies
Cell therapies
Biologics
A question of resources.
Food
Medical device
Pharmaceutical
Biologics
FDA Office of Quality
50% of fruit
20% of vegetables
80% of seafood and spices
40% of drugs
80% of the APIs used to make drugs
Typical drug mfr. employs 35 contract mfrs
around the globe
No distinction between U.S. and foreign plant
Regulatory Conference Update
Drug Shortages
Between 150 and 200 drugs suffered from
acute shortages, a four-fold increase between
2005 and 2012.
2012FDA Safety and Innovation Act was
passed to help eliminate drug shortages
FDA helped prevent 681 drug shortages since
2012
In 2015, only 68 shortages thru end of June
Regulatory Conference Update
Sources
Pharmaceutical Research and Manufacturers of America
GxP Lifeline (A Master Control Publication)
Healthcare Packaging magazine
Pharmaceutical Manufacturing Magazine
Business Monitor International
PharmaManufacturing.com
Bio Industry Organization
Fisher BioServices
Bloomberg
Healthcare Packaging Magazine