Research Methodology and Project Management in Biotechnology

Nucleic acid absorbs UV light maximally at 260 nm owing to its bases. Thus, DNA or RNA yield can be quantified based on this principle. Restriction endonucleases (type II) are one of the most important groups of enzymes for the manipulation of DNA. They are bacterial enzymes that can cut/split DNA of any source at specific sites and were first discovered in bacteria E. coli restricting the replication of bacteriophages, by cutting the viral DNA. This led to differences in the size of restriction fragments obtained due to digestion with specific restriction enzymes. A restriction map is formulated by comparing the fragment size produced in every single digestion with those from double digests. In target amplification, the nucleic acid region around the area of interest is copied many times by in vitro methods. Polymerase Chain Reaction (PCR) is the best-known and the most widely applied of the target amplification methods. Original sample DNA is digested by a restricted endonuclease, separated by agarose electrophoresis, and transferred by agarose electrophoresis, and transferred to a solid support (Nylon or Nitrocellulose membrane) followed by selective visualization of fragments using labeled hybrid.

DNA sequence has now become a routine procedure. It is the process of determination of nucleotide or base sequence of a DNA molecule/fragment. A probe is a nucleic acid whose identity is known and is used to reveal the identity or abundance of a target or sample. They are simple to prepare and are labelled with nucleotides that are radioactive, or fluorescent or have attached affinity labels. Also, by using a biotinlabelled primer, single-stranded probes can be obtained. Microarrays represent highdensity miniaturized arrays of molecular samples. The technology involves a series of probes immobilized on a glass slide as microdots, which are then hybridized with a mixture of test DNA sequences labelled with a fluorochrome.ization probes.

Following the success of the human genome project with 99.99% sequence accuracy, with no gaps, biotechnology has been revolutionized. Recombinant DNA technology comprises a battery of experimental procedures to isolate (clone) pieces of DNA containing specific genes. The usage of restriction enzymes for manipulating DNA and producing recombinant DNA along with advances in gene editing technology has paved way for diagnosing the candidate disease genes and treating human genetic disorders by restoring functional genes through the modification of the mutant gene or by introduction of a functional gene by Gene therapy. Array technology helps in the validation of recognized sequences, proteins, other biomolecules, drugs, etc. on a miniaturized platform. Quality management in the lab along with lab safety plans for biomedical labs requires adherence to various governmental regulations for protecting health and safety of lab employees and for the maintenance of safe working environment.

Genome analysis is carried out by genome mapping. Genetic maps can be linkage, cytogenetic or physical maps. Gene expression can be analyzed by genomics and proteomics Microarrays are emerging as useful closed systems for genomic (DNA microarray) and proteome (protein chip) analysis.

Bioinformatics applications are effective in generating the vast quantity of inputs. Term simulation is the computation for developing algorithms and software, construction of database and curation, and analysis of gene sequence, functions, and structures. Understanding of genetic control of complex dynamic traits has fundamental importance in research fields of agriculture, evolution, and biomedical genetics. The advances in bioinformatics tools have changed research in both basic and applied biological sciences and these tools are enabling scientists to gain knowledge of complex biological systems. Also, they allow implementation of results towards novel developments in biomedical applications and contribute to promoting both individual and population welfare.

Writing a scientific paper, or research report or presenting research data for oral presentation is an art that comes with practice and experience. This chapter intends to make the reader aware of the basic features of scientific writing and digital technology platforms for documents available

Writing a scientific paper, research report, or presenting research data for oral presentation is an art that comes with practice and experience. This chapter intends to make readers aware of the basic features of scientific writing and digital technology platforms for documents available.

Biological resource centres (BRCs) are an essential part of the infrastructure underpinning life sciences and biotechnology. They consist of service providers and repositories of the living cells, genomes of organisms, and information related to heredity and the functions of biological systems. The growing worldwide demand for biological resources provides good reasons for greatly increasing the number and quality of BRCs. BRCs provide essential expertise for the formulation of government policies on biological resources and for information and assurance to the public.

The establishment of national BRCs can help identify and address existing gaps and take advantage of opportunities not currently met by existing ex-situ collections. They can then improve the quality of services offered and achieve efficiencies and cost savings.

A global BRC network would connect national BRCs and provide the framework within which co-ordination, harmonisation and quality assurance could be provided. BRCs need to provide greater quality assurance than is currently ensured by collections and databases.

Intellectual Property (IP) is the intangible creation arising from the application of human intellect and its legal characterization is intellectual property right (IPR). With the emergence of modern biotechnology, the era of patents, copyright, and IPR have come into being. One needs to be conversant about IPRs and patent systems to protect, license, trade, and market his research and inventions. This chapter aims to prepare oneself to face the legal and ethical challenges of research and trade. IPR appears to play an important role in facilitating production and exchange in certain input markets.

This chapter introduces patenting and fundamental research, copyrights, trademarks, biotechnological patents, current issues in patenting, Indian response to patent upheaval and bioprospecting along with the existing risk-analysis system for biotechnology products, surveying agency authorities. Regulations in biotechnology apply to the production, sale and use of biotech products and genetically modified organisms and regulatory agencies conduct their functions to protect public health, safety, and the environment.

Genomics is the science of mapping sequences and analysing genomes. This chapter gives an overview of techniques of genome sequencing, gene mapping, sequence analysis, DNA sequencing and microarrays. Genomics offers sequencing, mapping, and analysis of a genome. With the help of computer-based techniques, a human genome was sequenced. Now it is possible to identify the function of genes from protein databases. Since proteins cannot be amplified like nucleic acid, the analysis of protein expression is challenging 2 DGE; MS and protein chips are the most widely used technologies for proteome analysis.

Technical advances began with the advent of array comparative genomic hybridization and single nucleotide polymorphism arrays and are enabling researchers to identify disease-associated genetic variants by virtually scanning the entire genome. With the help of these technologies, it is now possible to screen for common genetic variants and even rare small deletions and duplications i.e., microdeletions and microduplications. This has led to a virtual explosion of gene identifications. This chapter aims to provide an overview of new technologies.

This chapter discusses conceptual issues in arguing for the ethics of science and technology. Since we live in a world where scientific knowledge and new technologies are continuously challenging our values, and we have to live our daily lives and make decisions based on the fundamental values of human dignity in our civilisation, scientists are no exception. Governments and private sectors have recognized the importance of ethics required to reconcile the human imperatives of development and sustainability. It is necessary to conduct both in-depth research on ethics and strengthen ethics education in science and technology to solve the problems brought about by rapid developments in the field. Stem cell research, genetic testing, and cloning are giving human beings new power to improve health and control development processes of all living species. Concerns about the social, cultural, legal and ethical implications of such progress are the most significant debates of the past century and a new word has been coined to encompass these concerns, i.e. bioethics.

Medical biotechnology incorporates many of the topics that have already been discussed in this book. Right from developing new drugs to prospects of stem cell use and cloning, the possibilities are enormous.