Regulatory bodies and stakeholder organizations in drug and device manufacturing and distribution have long been working toward creating standards for temperature monitoring that ensure the shelf life, quality and safety of products. In the last 15 years of these ongoing efforts, mean kinetic temperature (MKT) has been identified as one of the potential tools available for evaluating the impact of temperature on product quality.
Continuous monitoring of an environment with a sensor during bio-decontamination allows you to decrease the number of indicators used in routine processes because there is accurate inline measurement data available. Chemical indicators (CI), biological indicators (BI) and enzyme indicators (EI) are used as part of bio-decontamination cycle development studies. These…
During 2021, the impact of COVID-19 pandemic on the life science industry moved on from initial chock to acceptance and finding a way forward. Throughout the year, COVID has been ever present, but the industry has managed the situation well. Now the sector will have to deal with the after-effects,…
ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and gene and cell therapy industries. From research through product commercialization, we provide the most advanced, integrated, and Quality system driven analytic capabilities and packages for biologic therapeutics as well as gene and cell therapy platforms. Our deep history of…
Developing and optimizing pharmaceutical manufacturing processes can be a complex process. In order to streamline these processes and bring drugs to market faster, it is important for pharmaceutical companies to focus on creating efficient processes. The creation of Active Pharmaceutical Ingredients (APIs) is a critical part of pharmaceutical production. API…
