Kemwell Biopharma

Using Spectral Technology to Meet CGMP Guidelines in the Pharma Industry  Just like most other industries, technology plays a major role in the pharmaceutical industry, and to fulfil the standards and regulations that are needed for pharmaceutical products, they often use spectral technology. Each nation has its own body such as America’s Food and Drug Administration (FDA) to ensure that over-the-counter medication and prescription drugs are safe and effective for use.  Organizations like the FDA have set standards to assess the quality of pharmaceuticals using Current Good Bio Pharmaceutical CGMP Manufacturing Practice (CGMP) guidelines. Even if the consumers may not be aware, CGMPs help assess the processes carried out in pharmaceutical industries by emphasizing on the use of the latest technology for maintaining effectiveness and safety. Purpose of Current Good Manufacturing Practice CGMPs scrutinize each and every aspect of pharmaceutical productio...

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 ...

Bioprocess characterization refers to the commercialization of drugs which are new. The manufacturers of the drug have to complete validation of drug manufacturing procedure. This is done so that the patient who will take medicine won’t face risk ever. It is basically collection of information and then its evaluation to deliver high-quality product in the end.   On every step, the data is checked which helps in the establishment of controlled stratagies and best planning. First of all, information is mined and then the risk is analyzed by making experiments in different ways.  What are the major goals of characterization studies? The main goals are identifying procedure parameter which impacts on the quality of product and then yield results. It helps in justifying manufacturing operations and identifying interactions become easier. With the help of this process, it becomes easier to deliver pure and reproductive products. Between the critical ...

As you know, contract manufacturing is getting popular all over the world, especially in the Pharmaceutical and Biotech industries. Contract manufacturing is considered as the process of outsourcing for the manufacturing of all the products of any Pharmaceutical organisation. There are lots of companies available to offer these contract manufacturing solutions for the pharmaceutical industry. With the services of these companies, any pharmaceutical organisation can reduce the manufacturing cost and can find the assurance of quality in the products with Outsourcing and contract manufacturing professionals . According to the reports, the need of contract manufacturing is growing in the global pharmaceutical industry and it will grow at CAGR of about 7% by the year 2020. Here comes the question that why pharmaceutical industry use depending on contract manufacturing and why the trend of contract manufacturing is getting popular in the Global Pharmaceutical sector.  F...

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...