PhRMA, the Pharmaceutical Research and Manufacturers Association, quoting a report by the Boston Consulting Group, notes that the drug development process in the United States takes, on average, 15 years for an experimental drug to go from laboratory to patient and costs, on average, $500 million!
The long road from initial research to final FDA approval and patient use includes the following stages and time periods.
Preclinical Testing: 6.5 years (including research)
Clinical Trials: 7 years (Phases I, II and III)
FDA Process Review and Approval: 1.5 years
Preclinical Testing involves laboratory and animal tests to show biological activity and safety for the disease for which its treatment is intended.
The IND, Investigational New Drug Application is filed with the FDA after successful Preclinical Testing.
Clinical Trials are conducted in three phases with volunteers to determine safety, dosage, effectiveness, side effects and adverse reactions from long-term use.
After this, a New Drug Application, NDA, is filed with the FDA. Upon approval by the FDA the physician many then prescribe for use.
The success rate is astonishingly low. Of 5000 compounds evaluated in early research and preclinical testing, only 1 will finally be approved.
In this justifiably complex discovery and approval process is it any wonder that pharmaceutical manufacturers scrutinize every detail of the process from the laboratory bench to the production and finishing process?
Is it not surprising that processing elements used successfully in the laboratory stages are carried through in all stages of scale-up to final product manufacture? If it works effectively in the early stages, the impetus is to carry on with success.
ErtelAlsop designs proprietary filter media and equipment to meet the specific needs for depth filtration in all stages of drug production. This expertise can be applied as well in the earliest stages of drug development by use of ErtelAlsop’s laboratory scale filter products at the laboratory bench level through scale-up to production volumes. For example, a new one-inch square sanitary filter press can be used to provide accurate, reliable scale-up data for full scale processing using only CCs of product. Other, larger lab scale filter units are also available.
Changing processing elements during scale-up is most often undesirable. It has been said that “The process is the product”. While changes may be unavoidable at times, maintaining the process elements throughout the process development to final production may help ease the final approval. ErtelAlsop offer filter products for all stages of the drug development and production process.
Our expertise lies in the manufacture of the equipment and highly effective depth filter media that can reduce bioburden, endotoxins and other particulates as well as color and odor. These include sanitary design, validated pharmaceutical grade lenticular format filter cartridges and filter pads and sanitary design filter housings.