Biosimilars

Biopharmaceuticals, 2018

Biotechnology Entrepreneurship, 2014

Promising Pharmaceuticals, 2012

Promising Pharmaceuticals 64 derivatives, allergenic patch tests and extracts, HIV and hepatitis tests, gene therapy products, cells and tissues for transplantation, and new treatments for cancers, arthritis, and other serious diseases. CBER reviewed the first vaccines to immunize persons against infectious diseases, such as polio, pertussis ("whooping cough"), and German measles. CBER research led to important discoveries to safely collect, prepare, and transfuse blood and blood plasma. 2. Biological products, industry history (1) Biological products were created with biotechnology, the scientific and engineering procedures involved in manipulating organisms or biological components at the cellular, subcellular, or molecular level. These manipulations were carried out to make or modify plants and animals or other biological substances with desired traits. Although examples of primitive biotech processes dated back to ancient times (such as the use of fermentation in brewing and leavening agents in baking), their use in medical and pharmaceutical applications was an innovation of the latter decades of the twentieth century. Some analysts compared the biotech industry's impact on global medical care with the computer industry's impact on communication. Biotech researchers produced products in essentially three ways: by developing ways to achieve commercial production of naturally occurring substances; by genetically altering naturally occurring substances; and by creating entirely new substances. Some of the tools used by biotech researchers included recombinant DNA and monoclonal antibodies. Recombinant DNA involved the ability to take the deoxyribonucleic acid (DNA) from one organism and combine it with the DNA from another organism thereby creating new products and processes. By using recombinant DNA techniques researchers were able to select specific genes and introduce them into other cells or living organisms to create products with specific attributes. Monoclonal antibodies were developed from cultures of single cells using cloning techniques. They were designed for use in attacking toxins, viruses, and cancer cells. Because the biological products presented for approval often involved new technologies or innovative therapies for diseases that had not been previously treated successfully, the approval process frequently proved to be long and costly. Many companies struggled financially through the 1980s waiting for an FDA determination.

BMC Proceedings, 2011

Cytotechnology, 1992

The Center for Biologics Evaluation and Research, whose regulatory authority includes monoclonal antibodies, cytokines, vaccines, toxins and somatic cellular therapies, communicates to sponsors issues for consideration in the development of biological products through the publication of "Points to Consider" and "Guideline" documents. This paper summarizes the available "Points to Consider" and "Guideline" documents and outlines recommendations from these documents for characterizing the ceils used to produce biological products. This is an NIH document which classifies the potential hazard levels associated with viruses and cell lines used to produce recombinant products. This "Guideline" also identifies the responsibilities of persons and organizations involved in

"There where is life, there is DNA, where there is DNA, there is "biotechnology". The discovery of insulin in 1922 marked the beginning of research and development to improve the means of delivering biotechnology products. From that period forward, investigators have contemplated every possible route of delivering biotechnology products. In recent years, the pharmaceutical industry has used different technologies to obtain new and promising biotechnology products as exemplified by the gene therapy, recombinant DNA technique, monoclonal antibodies, polymerase chain reaction, peptide technology, antisense technology and so on. The final aim of pharmacy and medicine is the delivery of biotech products at the right time in a safe and reproducible manner to a specific target at the required level. Gene therapy and RNAi technologies are considered the medical treatments of the future. Furthermore, novel, harmless viral vectors and non-viral gene therapy systems such as the 'gene gun', liposomes, microfabricated systems combine the principles of microtechnology and biology are also under investigation. In addition most of the biotechnology products are usually protein and enzyme based. So, the ability of proteins and enzymes to maintain a functionally active conformation under adverse environmental conditions is the most crucial factor. In our topic, we also tried to discuss bioinformatic-driven strategies that are used to predict structural changes that can be applied to wild type proteins in order to produce more stable variants. The most commonly employed techniques PEGylation, stochastic approaches, empirical or systematic rational design strategies. Finally, we want to say, overcoming the current obstacles, including government regulations, financial support, and large-scale production and manufacturing will lead us to a day where all biotechnology products are delivered in a targeted and safer manner.

Journal of Coastal Life Medicine

Brazilian Journal of Pharmaceutical Sciences, 2011

In recent years, the number of drugs of biotechnological origin available for many different diseases has increased exponentially, including different types of cancer, diabetes mellitus, infectious diseases (e.g. AIDS Virus / HIV) as well as cardiovascular, neurological, respiratory, and autoimmune diseases, among others. The pharmaceutical industry has used different technologies to obtain new and promising active ingredients, as exemplified by the fermentation technique, recombinant DNA technique and the hybridoma technique. The expiry of the patents of the first drugs of biotechnological origin and the consequent emergence of biosimilar products, have posed various questions to health authorities worldwide regarding the definition, framework, and requirements for authorization to market such products.