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Biotechnology in pharmaceutical sciences has brought about the production of monoclonal antibody, DNA, RNA probes for the diagnosis of various diseases; valuable drugs; edible vaccines like human hepatitis B; therapeutic drugs such as alkaloids, glycosides, steroids, flavonoids, tannins, proteins, enzymes, antibiotics, metabolites, etc.

Interference with the plant genotype leads to the expression of various recombinant proteins, which forms antibodies, vaccines, and several other proteins having various pharmaceutical applications. Development of hairy root culture by means of Agrobacterium infection makes plants less dependent on growth hormones for their future growth. This genetic transformation of tumor in plants also gives a better yield of secondary metabolites. Even today, a variety of pharmaceutical drugs and chemicals are being produced by genetic engineering with better quality and increased quantity.

Thus, plant biotechnology has provided us with a very efficient and economic technique for the production of a variety of biochemicals [—].

Much more than documents.

In industrial applications, plant biotechnology is used for the production of transgenic drugs. The major benefits are expected in medical, pharmaceutical, and health sciences. In medical sciences, it is used for the production of antibiotics, insulin, growth hormone, interferon, clotting factor VIII, vaccines, probes for infectious and gene therapy, etc. A major breakthrough in plant biotechnology was through rDNA technology, which led to the production of therapeutic recombinant proteins. The basis of the production of recombinant proteins is molecular pharming of therapeutic plants by rDNA technology, which is depicted in Fig 1.

This transfer is possible by using a suitable vector medium such as Agrobacterium sp.

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Successful transfer may lead to production of various transgenes. This transgenesis is followed by screening of plants. In this step, plants having the suitable gene expression for the desired recombinant protein are selected.

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Finally, recombinant proteins are purified to form various biopharmaceuticals and vaccines. Some important vaccines such as envelope surface protein hepatitis b virus humans , glycoprotein rabies virus , malarial B-cell epitope malaria , and Escherichia coli Lt-B toxin enterotoxigenic E. Figure 1. Production of recombinant proteins by rDNA technology. Colin G. Rousseaux, William M. Part of developmental pharmaceutics is the process of turning an active compound API into a form and strength suitable for human use — the drug product DP.

A pharmaceutical drug product can take any one of a number of dosage forms e. Excipients are added for many reasons.

The impact of each excipient on the human body must be evaluated. The API should be compatible with the excipients, and the effect of any variation in physical characteristics e. If there is a risk that any change in physical characteristics may produce changes in bioavailability, or any other actions of the formulation, controls should be put in place to monitor such changes.

The presence of any overage produced during manufacturing, and the role of all excipients, should be described. If an unusual excipient is used in order to produce a particular effect in the formulation, full information on the excipient must be given. The requirements vary according to the type of dosage form.

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For liquid dosage forms, the effect of changes in physical characteristics must be demonstrated — for example, the effect of changes in pH on the active ingredient. Other factors, such as ease of dissolution and changes in aggregation, must also be considered. The inclusion of other non-excipient additives, such as preservatives and antioxidants, must be justified.

Dissolution of a solid dosage form is critical, and the tests should be carried out for both non-modified release and modified release e. Correlation of in vitro with in vivo studies may be required for certain formulations. It is essential that the mixture of active ingredient and excipients in a solid dosage form is uniform: homogeneity must be ensured for all solid dosage forms.


The concept of process validation deals with the manufacturing process and its quality. Process validation is, however, more concerned with non-standard methods of manufacturing that might be used in the production process, and ensuring that they produce a final product of expected quality. Courtney V. Fletcher Pharm. Clive Wilson Ph. Education and practice of the pharmaceutical sciences is rapidly evolving in these modern times. The pace of such advancements creates an increasing need for updated and contemporary resources for students and faculty, and for practitioners in the fields of pharmaceutics.

I am pleased to see this book, which covers that gap by highlighting modern practices and recent advancements in the well-established field of pharmaceutical processing by wet granulation. This text features outstanding contributions from leading scientists across the globe from all practices of the profession—industry, regulatory, and academic.

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The topics cover the depth and breadth of the various facets of technology and practice. I am confident this book will enable a deeper understanding of the fundamental principles and provide a wider perspective of their practice to our next generations of students and scientists—while also fueling innovation in the evolving areas. We use cookies to help provide and enhance our service and tailor content and ads. By continuing you agree to the use of cookies. Sign In Help.

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Share full text access. Sambamurthy, K. Kar, Ashutosh. Pharmaceutical Chemistry, Volume I : Inorganic. Pharmaceutical Development Ser. Gad, Shayne Cox. Augsburger, Larry L. Pharmaceutical Drug Analysis. Pharmaceutical Production Facilities. Pharmacognosy and Pharmacobiotechnology. Principles of Organic Medicinal Chemistry. World Health Organization. Reviews in Pharmaceutical and Biomedical Analysis. Bentham Science Publishers.