Kemwell Biopharma

The Biosimilar council held a conference in which academic experts and number of government officials were present to discuss the landscape and future of Biosimilar industry.   The main focus of this conference was basically dedicated to the patients, public, and education of health professionals.   The effectiveness and safety of the Biosimilar should be known to the public and to spread this awareness,    the meeting was held in the year 2017. There are mainly five reasons due to which it is the right time to lead and focus on Biosimilar ·          Effective and safe The most important factor during the production of Biosimilar is that this can be helpful in the approval of the FDA.   It uses the same kind of mechanism for the particular biological brand and it can be used as a Biosimilar working. The FDA always requires the Biosimilar manufacturers to use safe methods and monitoring technique to check vario...

Drug formulation is the process to combine the chemical substances with the active drug for the production of the final medical product to use for human consumption. There is a very important role of drug formulation process in the success of any pharmaceutical company going to develop the product for the customers in the market. To design the effective and safe medical product for humans, interrupt formulation process is used from very early stages of research and studies to the final trials and testing of the manufactured product by any pharmaceutical company. In most of the cases, drug formulation is considered in the early stages of any development programme for the Pharmaceutical product however, many companies delay the process for the final stages of the development process. In this kind of situation, there is a risk of failure or expensive delay of any Pharmaceutical development program in the industry. When it comes to ensuring the effective and cost-saving appr...

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...

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...

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...