Biotechnology Raj Mutharasan

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Applications II

History – Early Developments

  • 1953 Watson and Crick determined DNA structure

  • 1970 First restriction endonuclease isolated

  • 1973 Boyer and Cohen establish recombinant DNA methodology

  • 1975 Kohler and Milstein describe production of monoclonal antibodies

  • 1978 Genentech produced human insulin in E. Coli

  • 1978 John Baxter reported cloning the gene for human growth hormone

  • 1980 Kary Mullis(Cetus Corp.) conducted in vitro, the polymerase chain reaction (PCR).

  • 1981 Genentech, Inc. cloned interferon gamma. Bill Rutter and Pablo Valenzuela identify hepatitis B surface antigen. Scientists at Ohio University produced the first transgenic animal.

  • 1983 Syntex received FDA approval for a monoclonal antibody based diagnostic test for Chlamydia trachomatis.

  • 1984 Chiron Corp. announced the first cloning and sequencing of the entire human immunodeficiency virus (HIV) genome

History – Middle Developments

  • 1986 Orthoclone OKT3® (Muromonab CD3) approved for reversal of acute kidney transplant rejection. Automated DNA fluorescence sequencer invented. First recombinant vaccine (for hepatitis) to Chiron Corp approved. First genetically engineered crop, gene altered tobacco plant approved.

  • 1987 Genentech received FDA approval to market rtPA (genetically engineered tissue plasminogen activator) to treat heart attacks. Recombivax HB® (recombinant hepatitis B vaccine) approved.

  • 1989 Epogen® (Epoetin alfa) a genetically engineered protein introduced.

  • 1990 Approval for human somatic cell gene therapy trial. GenPharm International, Inc. created the first transgenic dairy cow. The Human Genome Project launched. Estimated cost: $13 billion.

  • 1993 Chiron's Betaseron is approved for multiple sclerosis. Researchers clone human embryos and successfully nurture them in a Petri dish for several days.

  • 1994 The BRCA1 gene reported to cause of non-inherited breast cancers. Vpr, a gene governing reproduction of the HIV virus.

History – Recent Developments

  • 1994 The enzyme telomerase reported as responsible for the unchecked growth of cells seen in human cancers.

  • 1995 Gene therapy, immune system modulation and genetically engineered antibodies enter clinical trials.

  • 1996 Biogen's recombinant interferon drug. Avonex® approved for multiple sclerosis.

  • 1997 Researchers at Roslin Institute report cloning a sheep named Dolly from the cell of an adult ewe. Polly the first sheep cloned by nuclear transfer technology bearing a human gene appears later. A new DNA technique combines PCR , DNA chips, and computer programming providing a a new tool in the search for disease causing genes.

  • 1998 Favorable results with a new antibody therapy against breast cancer, HER2neu (Herceptin), herald a new era of treatment based on molecular targeting of tumor cells.

  • 2000 A near complete draft of the human genome map is produced, showing the locations of more than 30,000 genes.

An Overview

Market Values

Early Success

Cloning Challenges

Regulatory Challenges

Business Challenges

Industry Summary - 1999

Jobs in Biotechnology

Structure of Bacteria

Bacteria – SEM view

Structure of an Animal Cell

Biochemicals of Life

Pairing of Nucleotides

Central Dogma

Genetic Code

Essential Cloning Steps

Essential Cloning Steps

Amino Acids – Back bone of Proteins

Amino Acids – II

Process Overview

What are cells made of?

Concept : Growth Reaction

Concept : Cell Yield

Cell Yield – Formal Definition

Cell Growth in Batch Culture

Cell Growth - Kinetics

Typical Growth Rates

Nature of Specific Growth

Metabolic Quotients

Metabolic Quotients - II

Factors Affecting Growth Rate - Temperature

Factors Affecting Growth Rate - pH

Factors Affecting Growth Rate - DO

Growth Associated Product Formation

Non-Growth Associated Product Formation

Oxygen Transfer in Bioreactors

Oxygen Transfer in Bioreactors-II

Oxygen Transfer Coefficient

A Design Example

Biotechnology – The next steps

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