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Showing posts with the label Biosimilars Manufacturing

Check out the five reasons due to which there is lead in biosimilars in the market

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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...

Find out the effect of improved speed to the clinic by increasing automation in cell line development

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Do you know the role of automation in cell line development? The enhanced speed provides better quality, efficiency, and speed to the drug market. For a biopharmaceutical production company, the automated cell line has become really important but with the manual procedures, it can take a lot of time and difficult working tasks. The process can speed up using automated development and then the technicians can focus on the other important tasks they need to do. The date and timing of the cell growth can be scheduled according to the cell types. This helps the researchers to know the time when cells can be available for research projects. The certain factors which can limit the productivity in the automated process are the time required for assays, sub-clone of cells, maintenance and automation of cell-based protocols. There are a lot of automated platforms which are useful for reducing costs during the production of biopharmaceutical production. In the automated system, the...

Check out the different between Biotech and Biopharma companies

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With the advancing technological world, the medical field is also developing at a fast pace. When a person is not from the medical field, then he/she can’t find the actual difference between biotech and biopharmaceutical companies . Both of the companies deal with medicines and drugs but there is a huge difference between both of them.  In biopharmaceutical companies, the best methods are used for the production and design of products but in biotech companies, whole research is done after which development takes place. Various tests are conducted before the manufacturing starts and then the work of selling drugs is done at the final stage. Know about biotechnology This technology is based on the subject biology and all the products which use living organisms are qualified in biotechnology. There are some people who think that it is a modern application which treats diseases and enhance the level of the environment while improves manufacturing processes also. There a...

What's the secret to successful drug formulation?

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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...

Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation.

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For pharmaceutical companies, improved R&D productivity is a big challenge at the present time. There is always pressure to increase the development speed for the drugs and making it better as well as cost effective for the customers. The Pharmaceutical organisations are trying to hit the markets with the most promising and cost-effective drug products to provide the benefits to the maximum number of patients. However, there is always a big requirement of speeding up the development process by completing all the stages of the drug development process. As you know, there will be different stages during the process of drug development. It is very important to characterize the properties of drug substances in the early stages so that it can be easy to optimise the formulation of a drug product in the market. During the early stages of drug substance development , the companies understand the requirement of efficiency as well as safety. The formulation development can be ...

Growing importance of CMOs in the pharmaceutical market

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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...

BIOSIMILARS – TAKING THE BIOPHARMA INDUSTRY BY STORM

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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...