1. 9.4 Product Quality Control
Noor Perez, Emily Muñoz, Victoria Perez
Period 4

2. A company must be certain that its manufacturing process is capable of synthesizing a product of high quality.
QA stands for quality assurance, a department that deals with quality objective and how they are met and reported internally and externally.
QC stands for quality control.
As a protein is scaled-up technicians must monitor its concentration purity and activity to ensure it meets certain standards.
QC:
Handles product quality and testing during product development before marketing.
QA:
Deals with quality objective, such as how certain objective are met and recorded internally and externally.
At pharmaceutical companies like Gene Technology Inc. QC receives samples from fermentation or manufacturing areas.

3. Functioning(determines):
Testing may be done on animals like rats, mice, monkeys, and chimpanzees. Animal testing is useful for human marketing.
Type of Assay:
Functioning(determines):
ELISA
Presence and concentration of the protein activity
Enzyme activity 
Degree of protein activity
Multispecies
 pharmaceuticals
Behavior of protein in nonhuman test animals
Toxicology
Quantities of the drug toxic to cells and organisms
Potency
Effect of dosages on drug activity 
Stability
Length of time the product remains active
If a protein is a pharmaceutical, an Investigational New Drug(IND) Application must be filled with the FDA. 
New Drugs must go through clinical testing(clinical trials) that may last from 2 to 5 years of testing.

4. The different trials are:
Types of people accepted into trials 
Schedule of trials
Procedures 
Medications
Dosages
Study duration
Many Products that enter these trials never make it to the marketing.

5. Clinical trials in four phases:
Phase 1: a small of high risk patient test a new drug therapy for safety dosage rage and side effects.
Phase 2: the group is expanded to several hundred subjects, and additional safety, dosage, efficacy testing.
Phase 3: the group is expanded to several thousand people, safety and efficacy continue to be monitored.
Phase 4: compared those in existing drugs and production.
Clinical trials are usually double blind, neither the researchers nor the study subjects know which treatment the subjects are receiving: the new test drug or a placebo.
A placebo seems to be just like the drug but, however, they contain only the inactive ingredients and not the actual drug.
Double bind may result in biased data.  *VIDEO*

6. I f a product has been in the market for longevity of time, the FDA requires the product to undergo Phase IV trials.
This provides a more safe and efficient data base on larger and diverse populations.
If the company passes the trial, a marketing application is composed which includes all of the product descriptions and clinical trial results.
The FDA must visit the site of the manufacturing company to check if the company has Good Manufacturing Practices(GMP). They also meet the main company administrators and researchers.
This approval from the FDA may take 1 to 2 years.
For every product, a large system of people ensure and undergo the responsibility of the requiring high quality of the product before it once it reaches the market place.

7. 9.5 Marketing and Sales

8. Bring a Product to Marketing
Many promising products may not reach the market for reasons that may, or may bot, be under a company's control.
Some Factors that may delay a product reaching the marketing include:
A product may be found to be ineffective during preclinical or clinical trials. 
During testing, a product may be shown to have harmful side effects. 
Production may turn out to be uneconomical.
A product may trail to receive necessary regulatory approvals, such as from the FDA.
Competing products may already control a large portion of the market.
Patent protection for the product may be unobtainable, or another company may hold proprietary rights

9. Marketing Product Sales
As soon as a product receives all of the necessary approvals, it can be sold. 
Depending on the product in question, size of the company, and its operating budget, a staff with diverse talents is responsible for marketing the product.
Product Sales
Factors that affect a company's product sales include:
Effectiveness of the marketing team
Pricing decisions made by the company
Degree of patent protection afforded a product
Use of alternative therapies or products for the product's target population

10. Propriety/Patent Rights,& Community and Government Relations
A company may invest hundreds of millions of dollars in the development of a product. 
Other individual or company could steal protocols or product information. This is illegal and is referred to as "intellectual theft"
To prevent this, companies require their employees to sign propriety-rights contracts. Employees agree to keep secret the R&D of the product.
Then a company will move to secure patent protection for a product under development. 
Product Applications
Once a product is being synthesized and has approved for use for one application, it makes sense for a company to look for other applications for the particular product. 
Sometimes a company changes a product on a molecular level, resulting in different versions and different applications. 

11. Video!
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