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Showing posts with the label Contract Manufacturing Mabs

Using Spectral Technology to Meet CGMP Guidelines in the Pharma Industry

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Using Spectral Technology to Meet CGMP Guidelines in the Pharma Industry  Just like most other industries, technology plays a major role in the pharmaceutical industry, and to fulfil the standards and regulations that are needed for pharmaceutical products, they often use spectral technology. Each nation has its own body such as America’s Food and Drug Administration (FDA) to ensure that over-the-counter medication and prescription drugs are safe and effective for use.  Organizations like the FDA have set standards to assess the quality of pharmaceuticals using Current Good Bio Pharmaceutical CGMP Manufacturing Practice (CGMP) guidelines. Even if the consumers may not be aware, CGMPs help assess the processes carried out in pharmaceutical industries by emphasizing on the use of the latest technology for maintaining effectiveness and safety. Purpose of Current Good Manufacturing Practice CGMPs scrutinize each and every aspect of pharmaceutical productio...

Upstream cell culture processes for the production of therapeutic proteins

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These days, the biopharmaceutical industry is rapidly growing with the introduction  of new technologies and advancements. The therapeutic proteins play an important role in the upstream cell culture procedures. These proteins are engineered in lab for the use in pharma industries and these affect covalent bonds, enzymes. These proteins are really effective in revolutionary treatment of various diseases and vivo. It can allow individual treatment with specific and targeted therapeutic procedure as it compensates the deficiency of protein body. These proteins have less potential with common biological procedures and can cause adverse results. It can be tolerated in good manner and there are lesser chances of immune responses which elicit. There is no need for gene therapy when the replacement treatment can be done with cell line development and it would be done with the help of therapeutic proteins. It is FDA approved and clinical development which is really fast. One c...

Use of different technologies in improving monoclonal antibodies production

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Monoclonal antibodies contract manufacturing, Due to a heightened increase in collaboration between CMOs and pharmaceutical industries, there is a growth seen in the capacity investments. This is necessary for the contract manufacturing companies in order to meet all the necessary requirements of the pharmaceutical industries . Monoclonal antibodies are ruling the biopharmaceutical market and companies struggle while securing the manufacturing capacity of the company in such a time. For every biopharmaceutical company, it is important to pay attention to clinical capacity along with the commercial business. Why there is a sudden increase in Monoclonal antibodies production? Due to an increase in infectious diseases all over the world, the need to monoclonal antibodies is increasing every day.  These are the glycoproteins which are identical to the immune cells of the human body and it can assume that they are clones of the parent cell. As the need for these medicines ...