Kemwell Biopharma

In this modern technological world, India is getting ahead of many countries in terms of contract manufacturing and various developments.   Due to the high quality of international standards of the medicines available at low costs, India has chosen it with positive mode. It is an innovative and creative technique which can help in matching the changing trends in the field of medicines. It is a really dynamic and transitional field where one has to face lot of challenges and you also need to find out the growth options for it. It can be really possible for India to setup CMOs permanently up to the ground level in the near future. Due to increasing diseases,    the manufacture of drugs is also increasing and that’s why it has become important for the manufacturers to focus on the production of high-quality medicines. There are tight norms for the manufacturing of clinical trials, patents along with research in the medicinal field. The MNCs are really knowledge-based b...

As the APIs are becoming more and more complex, the demand for contract manufacturing is increasing. Most of the biopharmaceutical companies depend on CDMOs and contract development services in order to produce safe and high quality of sterile drugs. The demand for sterile fill finish is increasing and that’s why its manufacturing has become quite important. Specialized equipment and capabilities are necessary for completing complicated tasks. Due to various challenges in the production of these drugs, most of the companies depend on CDMOs in order to manage the proper manufacture of drugs. The smaller companies without any production capabilities depend on the outsourcing partners. Whenever the specialized capabilities are required, then the large companies take the help of contract manufacturing companies. One can definitely believe that CDMOs are a backup source for drug manufacturing companies. It is necessary for the drug pharmaceutical companies to choose the best pa...

Today, the role of CMO is increasing in biopharmaceutical industry as a large scale and this role is bigger than ever because of many good reasons. Almost every pharmaceutical company is getting the advantages of contract manufacturing with CMOs. As you know, the competition level is getting higher in the Pharmaceutical Industry and there is a requirement of focusing on proper planning and different kind of strategies to stand out from the crowd. Because of the increasing demand of quality for better results in the pharmaceutical industry, there is a big challenge to work on the strategies to stand out from the crowd of CMOs. When it comes to finding the best way to make the unique approach in the market as Biopharma CMO , there is a big need of innovative ideas for the strategic working with the pharmaceutical companies. Here are some of the best strategies to make your CMO unique for the pharmaceutical industry: Focusing on the partnerships and collaborations: ...

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...

Since the first use of biologics, it has grown to become a crucial tool in modern medicine. As the technology is getting better and there is a big advancement in biological research and production, the new life-saving treatment methods and drugs are available at the present time. Biologics are available as innovative treatment solutions for the patients who are affected by life-threatening and debilitating diseases and looking for proper treatment solution with the best medical products and tools. biologics are made with the use of living tissues or cells and it is very complex drug for serious health-related issues. As you know, biologics are available at expensive cost and there is a limited access of these medical products for the patients. Biosimilars are available as biologic medicine similar to the previously approved reference biologic that is available currently on the market. These drugs are made to use in the same way as biologics and available as a copy with the ...

When the need for drugs is increasing in the market, the important of CMOs is increasing in the market as they provide and supply necessary products to the customers with best perfectly engineered products. Irrespective of the growing collaboration between pharmaceutical companies and CMOs, people still want to know about the benefits of having a connection with contract manufacturing organizations . Here are some of the reasons due to which the importance of CMOs is increasing in the market today: Additional production capacity Every pharmaceutical industry can gain significant operational benefits by taking help of the CMOS because they can help in satisfying the demand of a particular drug. The pharma company won’t have to spend excess money and different resources to meet the particular demand of Contract Formulation Development because the CMOs will be always there to assist with the goals. The new pharma companies can be highly benefitted by taking help of the CMOS...

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...

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...

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...