biopharmatips

The commercial and scientific success of a pharma product can only be ensured with the knowledge of the drug development process and the innumerable milestones and tasks that are essential to a complete development plan. To determine the potency, purity, and identity of these pharma products, stability testing is essential. The stability of pharma products is the capability of a formulation in a specific environment and remain within its physical, therapeutic, microbiological, chemical, and toxicological specification. The stability studies of pharma products ensure the upkeep of product efficacy, safety, and quality throughout their life. Stability Testing is a complex process because of the involvement of several factors such as the interaction between active ingredients and excipients, type of dosage form, the stability of active ingredients, and container used for packaging. Types of Stability Testing  There are three major types of stability testing carried

The biopharma industry depends on change to grow in an environment that instantaneously demands higher quality, lower costs, and higher productivity. In upstream process development , biological materials are either acquired from outside or injected and bred in culture, under regulated conditions, to produce products. On the other hand, in downstream process development , the products are collected, purified, tested, and packaged. Different forms of biopharmaceutical process development involve technicians to wisely control the environment in which the cells grow.  If the product is to be used as a drug, biomanufacturing experts must work in places where current Good Manufacturing Practices (cGMP) are followed strictly. The progress witnessed in the industry has been remarkable, but the refined exterior of bioprocessing hides an interior of despair that cries under the burden of current demands. The rise in production achieved previously have been a result of enha