BIOTECHNOLOGY A Review

What is biotechnology?

Any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use. (UN Convention on Biological Diversity 1992,2003) A set of tools comprised of a series of techniques that can help solve a multitude of problems. These tools can be biological, chemical, instrumentation or software. (Biotechnology: laboratory skill course. K. Brown. 2011) An interdisciplinary field merging basic science, applied science, and engineering. Study genetic engineering, cell biology, molecular biology, and microbiology, analytical instrumentation, and bio processing. Learn about the latest research in immunology, virology, genomics, proteomics, and bioinformatics. (Learningin3D)

Life Science Research vs. Biotechnology Research  Basic life science research is driven by curiosity to understand more about life. Its goal is to understand how a system works.  The goal of biotechnology research is to develop something to help solve a problem; this type of research is called applied research.  Example: If a new virus that infects humans is discovered, basic research scientists would investigate the normal mode of action of the virus, its nucleic acid sequence, and the proteins that are important for its virulence. Applied scientists would take that information and develop drugs and a vaccine to combat the virus.

AREAS OF BIOTECHNOLOGY Biotechnology DiagnosticsEnvironmentGenetic EngineeringFormation Technology Crop Improvement Agriculture BioinformaticsBiofuelsGenomics/ProteomicsAnimal AgricultureMedical DevicesPharmaceuticals

Biotechnology Curriculum by Industry  Pharmaceuticals 20%  Medical Lab 15%  Biofuels 15%  Environmental 15%  Food Science 15%  Forensics 10%  Regulatory 10%

Regulation of Pharmaceuticals  FDA  The FDA Modernization Act (FDAMA) of 1997 affirmed the FDA’s public health protection role and defined the Agency’s mission:  To promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.  To protect public health by ensuring foods are safe, wholesome, sanitary, and properly labeled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labeled; and public health and safety are protected from electronic product radiation.

FDA’s mission continued…  To participate with representatives of other countries to reduce the burden of regulation, coordinate regulatory requirements and achieve appropriate equivalent arrangements.  As determined to be appropriate by the Secretary of Health and Human Services, to carry out the tasks above by consulting with experts in science, medicine, and public health, and by cooperating with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.

Pharmaceutical Culture  FDA is the regulatory authority.  Within the individual companies, the Quality Assurance Department is that authority.  Regulations  Current Good Manufacturing Practices (cGMPs)  Code of Federal Regulations, Title 21 Parts 210/211

What are cGMPs?  Current Good Manufacturing Practices for producing pharmaceuticals  Purpose: to make sure that drugs are manufactured to the same high standards that are required for their approval (

SUMMARY OF cGMPs  Every operation, analytical test and practice should have a written procedure  All personnel should be qualified and trained to do the job  All decision making personnel should be qualified to make the decision  All equipment and procedures should be validated to make certain the product can be safely and effectively manufactured  Product should meet quality standard  Quality unit approves everything

DRUG/BIOLOGICS  DRUGS  Articles intended for use in the diagnoses, cure, mitigation, treatment or prevention of disease in man or other animals  Articles (other than food) intended to affect the structure or any function of the body of man or other animals  Center for Drug Evaluation and Research (CDER)

DRUGS/BIOLOGICS  Biologics  Isolated from living systems (human, animal or microorganism)  Complex mixtures that are not easily identified, include:  Vaccines  Blood and Blood components  Allergenics  Gene Therapy  Recombinant Therapeutic Proteins  Tissue for Transplantation Center for Biologics Evaluation and Research (CBER)

QUALITY  The suitability of either a drug substance or drug product for its intended use. This term includes attributes such as the identity, strength and purity  The process of assuring, confirming, verifying that all aspects of the manufacturing operations are in conformance with:  Approved specifications  FDA requirements  Common Sense

Quality Control/Quality Assurance Quality Control  Product evaluation  Chemistry  Microbiology  Physical testing TESTING Quality Assurance  Documentation Review  Regulatory Issues  FDA/NDA Compliance confirmation PAPERWORK

DOCUMENTATION  All documents are to be prepared, reviewed, approved, and distributed according to written procedures, can be on paper or electronic  Document control procedures  Revision histories must be maintained  All documents must be retained for specified periods of time.

MORE DOCUMENTATION  Standard Operating Procedures  Batch Production Records  Laboratory Control Procedures  Documentation Control  All operations must be recorded in real time  Critical operations should be double-checked

SOP- Standard Operating Procedure  A document that describes how to complete a common task.  Necessary to ensure workers comply with company policy and industrial standards  Usually written on a template specific to the company  Should be written clearly so it can be understood and followed by anyone expected to perform the procedure  Once drafted the SOP is approved by a department manager.

SOP (Insert 1 here)

Master Production and Batch Records  To ensure consistency, Master Records for each product must be created and confirmed correct  The Master is a recipe and must include all forms and manufacturing instructions.  Master documentation identifies the product but does not include the batch number.  The Batch Production Record (BPR) is a copy of the Master record that is issued for a specific batch/lot  The BPR is assigned a unique batch/lot number  The BPR will have spaces for data entry and signatures.