Kemwell Biopharma

In the past few decades, biological therapeutics have performed a significant role in fighting against autoimmune disorders, cancers, and diseases that small molecule drugs have been unsuccessful in alleviating. The fast growth of therapeutic recombinant proteins is mainly because of technological advancement in cell line engineering, clone screening, and expression vector design. The primary goal in recombinant protein development is to produce a stable monoclonal cell line that consistently expresses the given recombinant protein at the desired quality through a cost-effective and efficient manufacturing process. Today  biosimilar development  has moved to a new phase guided by genomic insights and research, together with evolving technologies that are driving cell engineering into an uncharted future. People working in cell line development technology in the biopharma industry must cope with several contradictory priorities. They often must present their co-worker...

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 ...