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Showing posts with the label Stability Studies

Check out the challenges and opportunities in oral formulation development

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There are various challenges and opportunities which are faced by scientists during the development of oral formulation. The dose requirements in the development help the manufacturers to explore opportunities and formulations to better solubilization. There are a lot of factors which are included in the development are organic and aqueous solubility, stability, polymers, compatibility, surfactants, types of solubilizers and lot more. The development of safe oral formulation needs liquid dispersions instead of the solid ones. In order to get a particular dosage with high quality, efficacy, and safety, people use the best quality of oral formulation.   Challenges in Oral formation development Whenever a kind of drug is manufactured, then there are a number of challenges faced by the companies and the same happens during the oral Formulation Development procedure. The aging population will be looking for medications which can treat diseases caused at later stages of ...

What is the importance of collaboration between CMOs and Pharmaceutical Companies?

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Over the last two decades, the collaboration between contract manufacturing organisations and pharmaceutical companies has become prominent and the contract manufacturing companies are playing a big role in the development and production process for the pharmaceutical industries. It is true that the smaller pharma companies are getting help at a bigger level with contract manufacturing organisations as compared to the leading companies in the market. For the smaller companies, about 80% of the manufacturing process is completed by CMOs at the present time. According to the reports, two third of the manufacturing process is completed with the help of CMOs for many life science companies. It is true that contract manufacturing companies are looking to expand the role in pharmaceutical manufacturing projects and they are expanding the services for the clients in the market. Today, Medical and pharmaceutical companies rely on a big level on CMOs and these companies are avail...

Why Choose A Formulation Development Service Provider For Drug Formulation Development?

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In the pharmaceutical industry, formulation development services are required at a large scale and it is one of the priorities of the industries. In this service, several kinds of complex processes are included whether it is about the design of manufacturing root or proper dose of the several kinds of drugs manufactured by the company. Today, most of the pharmaceutical companies are getting the outsourcing services for formulation development with the companies. This service is required on priority to stay in the competition in the market. There are several companies available in the market to offer the services for formulation development for your Pharmaceutical organization. Here are some of the good reasons to go for the services of formulation development companies: Cost effective services: Cost-effectiveness in the manufacturing process is always one of the priorities for the business organizations. If you are going with services of and Outsourcing formulation de...

The CMO Advantage in Biologics Manufacturing

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If you want to know the CMO advantages in biologics manufacturing then you have to read this article. For understanding this concept you need to know what biologics manufacturing is. It is actually technologically complex and highly unique process. If you will compare this concept with small molecule manufacturing then you will find many different things. This biologics manufacturing really needs good planning and experienced. This process is very much risky. If any biotech company requires such amazing capabilities of manufacturing then partnering with biologics contract manufacturing organization can be a great solution. Although Biopharma CMO for biologics is not so well developed if these biologics industries do partnership then it can be profitable for both of them. There is no denying that there is a risk but this can be profitable for a long term. Acceptance of contract biologics manufacturing In the industries of biotech’s early years, there is not a good num...

The Growing Importance of Collaboration between Pharmaceutical companies and Contract Manufacturing Organizations

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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...

What Is the Difference Between Biologics And Biosimilars?

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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...

5 Easy Ways to Avoid Antibody Production Mistakes

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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...

5 Common Questions Related To Stability And Storage

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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...