Kemwell Biopharma

Biologics Biologics are medicine derived from living cells and constituents of human bodies like Ribo Nucleic Acid (RNA), Deoxyribo Nucleic Acid (DNA), or hormones. The first biologic developed for therapeutic use was insulin. Currently, biologics have become the fastest growing drugs in the Pharmaceutical Industry with around 300 biologics available for human consumption. Biologics are widely used to treat a vast number of diseases including cancer and rheumatoid arthritis. They are better in targeting cancer producing cells due to its efficient binding nature. The Pharma Companies estimate that by the year 2019, sales of biologics would generate a revenue of approximately USD220 billion annually. However, only a small fraction of biologics, especially the monoclonal antibodies (mAbs) is going to create most of this revenue. Entry of Biosimilar in Pharmaceutical Industry Biosimilar, as the name suggests, are “highly similar” to one of the FDA-approv...

Antibody or immunoglobulin is a protective protein which is produced by the immune system in response to a foreign body or antigen. These antibodies recognise the antigen and neutralise it by phagocytosis. A wide range of substances can act as antigens including the disease-causing pathogen and other toxic materials like insect venom. Currently, medicine has evolved into a new era of personalised therapy. It has led to  Monoclonal Antibody Development   (mAb) which can treat a wide range of diseases.                   Monoclonal antibodies develop  from identical immune cells which are all clones of a unique parent cell. They show monovalent affinity in recognising the antigen. Since the first licensing of the monoclonal antibodies 34 years ago, its market has seen exponential development in the last few years. Now they used to treat a wide range of diseases like cancer, arthritis, multiple sclerosis and heart d...

It was the mid-1990s, when pharmaceutical companies began developing their own versions of medical products. It was unregulated and unheard of at the time, but a steadily growing trend. Comprehensive guidelines were only laid down between 2005 – 2006 by the EU. Not long after, the WHO followed suit and finalised a more consistent set of guidelines for Biosimilars Manufacturing . And thus, began the mainstream prevalence of Biosimilars around the world. Biosimilars are basically ‘approved’ replicas of innovator biologic products, made by different companies. Biologic medical products are mostly made via DNA recombination technology and comprise of highly complex molecular structures as opposed to normal generic drugs. Normally, they are responsive and highly sensitive to changes in the manufacturing environment. Therefore, the Biopharmaceutical product development process must be able to fully replicate the properties of the innovator product, in order to be available in...

Monoclonal Antibody Development is the recent topic of debate in the medical scenario. Monoclonal Antibodies, often referred to as mAbs, are a proven effective therapeutic modality in human malignancy. Minute structures of Mabs doesn’t allow it to be seen by the naked eye. They are laboratory-produced antibodies derived from the millions of antibodies which the body makes every day to fight foreign invaders. Since their inception, Mabs have radically transformed understandings about the pathways of disease. Significance of Monoclonal Antibodies Fights Cancer Cells   Mabs specifically target cancer cells while retaining healthy ones. This medical method means fewer side effects than conventional chemotherapy or radiotherapy. In addition to this, Mabs provide an important tool to harness the body’s own immune system t fight cancer, called Immunotherapy. Treatment of chronic inflammatory and Autoimmune Diseases Mabs have not only been successful towards cancer ce...

One of the most crucial and vital aspects of biopharmaceutical development and manufacturing is Drug Stability. Millions of dollars and a whole lot is put on the line for the company involved with even the smallest mishaps. Owing to the importance of this critical facet, Stability Studies are conducted during various stages of development to ensure that the drug remains safe and potent after it exits the manufacturing facility. Listed below are a few common tests along with a brief explanation.  1. Real-time Stability Test Conditions Real-time stability tests are considered the best way to determine the shelf life of the drug. They often span for a time period of about two years. Pharmaceutical companies perform these tests at room temperature, under natural light and an expected level of humidity. These tests are performed periodically until the drug fails. 2. Accelerated Stability Test Condition In this type of stability study , the drugs are subject to stress...