biopharmatips

Biopharmaceutical is one of the most elegant and sophisticated achievements of modern science. The large, composite structures of these drugs look extraordinary in the 3-D modeling systems. Additionally, they also perform their tasks incredibly well, offering high value with fewer side effects. Today, various multinational pharmaceutical firms are slowly moving to biopharma on a large scale. However, with this comes several challenges. Considering the growth the industry has seen and the intricacies of biopharma, it is not surprising that major changes are needed to equip laboratories and operations in biopharma. Here are some of the major challenges that the biopharmaceutical Process Development industry is facing right now: Some of the leading nations that produce biopharmaceutical drugs lack research components and best manufacturing practices. Pharma firms must be built in a way that they are equipped with the best operational facilities. Cost pressure is expected t

A few years back, US drug authority Food and Drug Administration (FDA) published a guidance work that introduced the concept of Process Analytical Technology (PAT) and redefined quality assurance and pharmaceutical manufacturing for the future. In the same guidance a concept known as "real-time release," was introduced, which is defined as "the ability to assess and certify the suitable quality of final and/or in-process product based on process data". PAT enables the introduction of innovative technologies into manufacturing in the pharmaceutical industry. In today's competitive environment, firms must strive to enhance pharmaceutical quality control while lowering production costs. PAT’s goal is to improve understanding and regulate the manufacturing process, which is as per the FDA's existing drug quality system. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities, and

The shift toward evidence-based drugs and increasing cost burden is putting pressure on biopharma firms to market drugs through low-cost and highly efficient production methods.       Cost-effective and efficient paths to candidate drugs are established during the drug development lifecycle. It examines the influence of various parameters on product quality and process performance. Access to precise analytical information at the right time is essential to complete process development projects efficiently and effectively.  Consequently, different methods are evaluated frequently and optimized through different phases of the drug development lifecycle for product characterization.    With robust and well-designed analytical process Development and devetesting strategies, it is easy to confidently ensure product quality. This is a significant responsibility and represents a substantial amount of work that must be documented and communicated clearly to ensure effective and effici

In today’s competitive pharmaceutical market, a good product strategy and careful planning are vital to succeed. Pharma companies are competing on all fronts to develop innovative products to gain an upper hand in the market. Often these products fail to secure an advantage and end up being just another high cost centre for the company.  Thousands of clinical studie are being carried out as we speak, but only a few drugs get approval. In other words, the success rate of drugs under experiment making it to the shelves of a drug store or your medicine cabinet is quite low. This low success rate puts a lot of pressure on firms to keep a large set of products in the pipeline, thus increasing demands on process development groups to lower time-to-market and time-to-clinic. Additionally, the recently approved proteins are monoclonal antibodies that will need lifetime doses 10-100 times bigger than various recombinant protein drugs.  Drug process development is not quite tra