Biotech Basics
What does "GMP" stand for in the biotech industry?
Good Manufacturing Practice
What is the primary function of PCR (Polymerase Chain Reaction)?
To amplify specific DNA sequences.
What is the first phase in clinical trials called?
Phase 1
What is gene therapy?
A technique that uses genes to treat or prevent disease.
What therapeutic area is BIB specialized in?
Monoclonal antibodies and recombinant proteins
What is the primary use of CRISPR technology?
Gene editing
What is a bioreactor used for in biotechnology?
It's used to grow cells or tissues for the production of vaccines, antibodies, or other biologics.
What is an IND in drug development?
Investigational New Drug application, submitted to the FDA before human trials can begin.
What is the difference between small molecules and biologics?
Small molecules are chemically synthesized, while biologics are made from living organisms.
What kind of partnerships does BIB engage in?
Collaborations with biotech and pharmaceutical companies to develop therapeutic pipelines.
What is a plasmid?
A small, circular piece of DNA that is separate from the chromosomal DNA and can replicate independently, often used in genetic engineering.
What is the term for using living organisms to produce fuels, chemicals, or materials?
Industrial biotechnology or bio-manufacturing.
What does ADME stand for in drug development?
Absorption, Distribution, Metabolism, and Excretion
What are antibody-drug conjugates (ADCs), and how do they work in targeted therapy?
Antibody-drug conjugates are targeted cancer therapies that combine an antibody specific to cancer cells with a cytotoxic drug. The antibody delivers the drug directly to the cancer cells, minimizing damage to healthy cells.
How does BIB contribute to clinical trial development?
By providing expertise in the development and production of biologics like monoclonal antibodies.
What are recombinant proteins, and why are they important in biotechnology?
Recombinant proteins are proteins that are genetically engineered by inserting a gene encoding the desired protein into a host organism. They are important because they enable the production of therapeutic proteins, such as insulin and antibodies, at large scales for medical treatments.
What is the role of monoclonal antibodies in targeted therapies, and how do they improve patient outcomes?
Monoclonal antibodies are engineered to bind to specific antigens on cancer cells, enabling targeted therapy that can inhibit tumor growth and enhance the immune response. This precision reduces side effects compared to traditional treatments and improves patient outcomes in various cancers.
Which regulatory agency is responsible for drug approvals in Europe?
European Medicines Agency (EMA)
What is gene therapy, and how does it differ from RNA-based therapies?
Gene therapy involves inserting, altering, or removing genes within an individual’s cells to treat disease, whereas RNA-based therapies, like siRNA, modulate gene expression without altering the actual DNA.
What technological innovation is BIB most known for?
Cutting-edge development and scaling of monoclonal antibody production.
What was the first biotech product to receive FDA approval?
Human insulin produced by recombinant DNA technology (marketed as Humulin).
What is the significance of biosimilars in the biotechnology market, and how can they impact patient access to therapies?
Biosimilars are biologic medical products highly similar to already approved reference products. They increase competition in the biotechnology market, potentially lowering treatment costs and improving patient access to essential therapies, such as monoclonal antibodies and other biologics.
How long, on average, does it take for a drug to go from discovery to market approval?
10-15 years
What is the significance of fusion proteins in therapeutics, and how do they work?
Fusion proteins combine two or more proteins to enhance therapeutic efficacy, often designed to deliver a drug or boost immune responses by targeting specific cells or pathways, such as in cancer immunotherapy.
How does BIB support early-stage biotech companies?
Through partnerships and providing infrastructure for drug development and clinical trials.