Kemwell Biopharma

Producing biosimilars is quite challenging as drug manufacturers face multiple bottlenecks while ensuring product quality and patient safety. Analytical method development and validation provides the data needed to manufacture safe and valuable drugs. The validation and growth of analytical methods is key to drug development. The biopharma industry has managed to reduce risk by utilising analytical platform technologies for drug conjugates, monoclonal products, and new molecules. In the pharma industry, validation and analytical characterization are mandatory for quality assurance and quality control. Several drug authorities emphasize on the validation of the processes implemented in the industry. Validation is a systematic and formal way to show the appropriateness of the assay method to offer useful data to ensure the process provides consistent and satisfactory results.  The procedure for analytical method development is as follows: 1 . The objective of analyt...

The biopharmaceutical industry is complex and dynamic and each year it continues to grow at the rate of 14% to 15%. This year the industry is demanding new and enhanced technologies to lower costs, boost efficiencies, especially in developing economies. Enabling this upward trend is the gradual introduction of innovations in manufacturing productivity. Growth in products in the area of cellular/gene therapies will be so rapid that the industry is expecting a falling bioprocessing capacity crunch. One exception to the growth is in the biopharmaceutical sector as very few small CMOs are being founded or coming online recently. Here are some of the key drivers in the field of biopharmaceutical process development:   Biopharma industry and supplier growth continue to remain healthy: The biopharma sector and its suppliers, both services and equipment have grown steadily at close to 12–14% annually in terms of revenue over the past two decades. This year, suppliers ...

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...

The entry if new biosimilars in the market will not only reduce prices but also increase competition. This new development will help patients get access to innovative medication. However, regulatory burdens and high manufacturing costs make it difficult for biosimilar contract manufacturers to reduce prices to the same extent as generics. On the other hand, there is apprehension among biosimilar manufacturers that reducing prices significantly will eliminate the incentive for them to enter the biosimilar space. Addressing these difficulties presents an opportunity to lower drug costs and improve patient access. What’s the Current Practice? For outpatients, reimbursement for medicines administered by providers is based on the Average Sales Price. Medicare pays the provider Average Sales Price + 6% of the medicine. Due to the lag between published Average Sales Price data and product launch, payers depend on Wholesale Acquisition Cost until the Average Sales Pric...

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...

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...