Kemwell Biopharma

Despite the clinical trials of drugs, RWE has become one of the most important strategies which can help researchers to know about the performance of the product and the whole information outside the clinical trials. Whether it includes billing databases and disease registries or it includes electronic health records, Real-World Evidence can help to know the results of a medicine. There are some factors with which RWE can be helpful and here are some of these points which can provide that RWE is highly important in knowing the outcome of drugs and much more: ·          The effect of environmental factors on treatment ·          Knowing drug interactions which can be safely performed ·          Observed advantages of medicines ·          Performance of drug against medicines which were approved in past. · ...

Most of the CMOs around the world are planning to make an investment in the capacity so that the requirements of the pharmaceutical companies can be met. In single-use investment, both upstream and downstream procedures like Purification technology and bioreactors are used. The development of new expression systems with better capabilities are getting established by the CMOs. The companies are also making an investment in the microbioreactors as it can help in the improvisation of biopharmaceutical develm op ent and enhancement in the speed of production.   biopharmaceutical develm op ent   Since the monoclonal antibody products are introduced in the market, they are known to be one of the dominant components of the biopharmaceutical market. During the development of monoclonal antibodies, the greatest challenge faced by the company is securing the manufacturing capacity. It is necessary that both the commercial and clinical capacity is secured in a comp...

During the span of last three decades, CMOs have been playing a necessary role in the biopharmaceutical industries across the world. Around two-thirds of manufacturing activities of the pharmaceutical companies is carried on by the CMOS. Whether it is a well-established company or a small commercial drug company , Contract manufacturing organizations are helping in the manufacturing process to the most extent. The pharmaceutical company can easily enter into the new global markets with less financial risks. commercial drug company Improving Relationship with CMOs Each and every pharmaceutical company can be able to improve process efficiency by taking help of contract manufacturing organizations. The collaboration between pharmaceutical companies and CMOS can ensure high efficiency and maximal productivity of drugs and here are the main key points to maintain the nice relationship between both companies: ·         Enhanced Process...

With the increase in a number of diseases and illnesses spread in the world, it has become necessary to find out the best ailment. Drug manufacturing marketplace keeps changing and the main reason behind this change is to reduce costs and enhance quality and capacity. These days, pharmaceutical industries are relying on the CMO market and there are various reasons because of which this is happening. The only work left to Pharmaceutical industries is paying attention to the core production along with R&D because the secondary and tertiary production is taken care by the Contract Manufacturing Operations.  Drug manufacturing   What is the importance of Contract Manufacturing Organizations? ·         Better manufacturing skills The use of advanced technologies for the manufacturing process of drugs is common and when it comes to introducing a new drug into the market, then it needs huge investment for the manufacturing proc...

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...