1950s
Structure of DNA described, as well as its method of replication
1970s
Advent of recombinant DNA technology began with isolation of restriction enzymes
Bioethics
The study of decision making as it applies to moral decisions that must be made due to advances \n in biology and technology.
ethical concerns with GMOs
cross-pollination with non-genetically modified crops
may decrease genetic diversity
benefits of genetically engineered human insulin
(versus insulin from animals)
less chance of immune response
avoids ethical issues of animal use
more efficient process
ethical concerns with CRISPR/Cas9 gene editing
alterations in germline cells will be passed onto future generations
Genomics
investigates the whole genome, the full complement of DNA in a cell
Proteomics
studies to proteome, the entire protein complement of a cell or organism
Transcriptomics
is a study of the transcriptome, every RNA transcript expressed in a cell or organism
Metabolomics
investigates the metabolome, all metabolites in a cell or organism present at a specific time
Microbiomics
investigates a microbiome, all microorganisms living in a place at the same time
Bioinformatics
a database of each of the “-omics” vast amounts of data
Biopharmaceuticals (biological drugs)
protein-based drugs
are produced by a living system
cannot be terminally sterilized using heat
are more sensitive to how they are handled in the manufacturing process
Bringing a Biopharmaceutical Product to Market
Identifying a product
Research and Development
Clinical trials
Manufacturing. Sales and Marketing
Disadvantage to using prokaryotes in the production of biopharmaceuticals
Prokaryotes are unable to \n properly fold and assemble more complicated eukaryotic proteins
Clinical Trials
Phase I – Phase with healthy volunteers or people with the disease/condition. The primary focus is on studying \n safety parameters of the drug. \n Phase II – Phase with volunteers who have the disease or condition. The primary focus is efficacy and \n determining side effects. \n Phase III – Phase with volunteers who have the disease or condition. The primary focus is a broad-scale study \n of the drug’s efficacy, and monitoring side effects.
Limitations of using biotechnology for pollution monitoring and waste management
Microbial activity may change with seasonal changes in temperature
Degraded waste byproducts may still be a major problem
New technologies might be more costly and take more time
Concerns regarding long-term outcomes from using genetically modified organisms
Quality Assurance (QA)
Oversees and ensures that all products meet \n standards of quality prior to being released \n for sale
Responsible for document control
Quality Control (QC)
Conducts testing on raw materials, in-process \n samples, and finished products using test \n records
Standard operating Procedure (SOP)
controlled document that contains step-by-step instructions on how to perform a routine activity within a company
Batch Record
contains step-by-step instructions on how to manufacture a product, including spaces for capturing information specific to the task
Assay Validation
describes the process of providing documented evidence that a method does what it is intended to do
Test Record
contains step-by-step instructions on how to test a raw material or a product, including spaces for capturing information specific to the task
Informed Consent
process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention
STEPS IN PRODUCTION
Quality Control tests, and approves or rejects raw materials, following test records.
Manufacturing produces the product following a batch record.
Quality Control tests the final product following test records.
Quality Assurance approves or rejects the final product based on final product specifications
patents last for
20 years
The Food and Drug Administration (FDA)
ensures that food and beverages are safe for human consumption and that therapeutic drugs and devices are safe and effective. Also, responsible for regulating \n biopharmaceuticals for use in humans, regulate cGLPs and cGMPs
The Occupational Safety and Health Administration (OSHA)
responsible for regulations pertaining to worker \n safety
The Environmental Protection Agency (EPA)
protection of human health and the environment
The U.S. Department of Agriculture (USDA)
ensures that agriculture and livestock are protected
Food, Drug, and Cosmetic Act
tightened controls over drugs and food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government's ability to enforce the law
Genetic Information Nondiscrimination Act
prohibits bias that is based on information derived from DNA testing
Pure Food and Drugs Act
prohibited the sale of misbranded or adulterated food and drugs
21st Century Cures Act
designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently
Good Laboratory Practice (cGLP)
a quality system with a set of regulated practices used to collect safety data on a drug or product being developed (non-clinical/ pre-clinical) to ensure regulatory compliance in laboratory studies. (FDA oversight)
Good Clinical Practice (GCP)
a quality system used by governments to establish their own regulations for clinical trials involving human subjects (FDA oversight)
Good Manufacturing Practice (cGMP)
a quality system with a set of standardized practices that ensure steps are taken to produce consistently safe and effective products. (FDA oversight)
Good Documentation Practice (cGDP)
the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner (part of cGMP). (FDA oversight)