From diverse populations to supportive regulatory frameworks, Israel and Turkey are increasingly attracting multinational trials. We explore the range of factors that are making both countries appealing destinations to trial new medicinal products.
For clinical trials operating across different counties, challenges with regulatory requirements must be overcome to avoid delays, while text translations need to be precise to ensure consistency globally while maintaining country-specific demands. We speak with experts at BAP Pharma to learn more about managing these fundamental issues, alongside the importance of flexibility in secondary packaging and the company’s patient-centric approach.
There are many opportunities for nontuberculous mycobacteria to spread in water distribution systems. This can lead to serious lung infections in anyone, and people with weakened immune systems are particularly susceptible. We look at some of the potential transmission points of NTM in water systems, identify areas at highest risk, and explain how Pall’s suite of water filtration products can ensure safety in health facilities.
Process intensification has long been viewed in biopharma production as a means to increase production efficiency and reduce costs. Yet the pathway there is not always straightforward, there are a number of approaches that can be taken. New technologies are pivotal in delivering advances in process intensification, and we learn more about how the 3M™ Harvest RC Chromatographic Clarifier can achieve this.
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Africa remains a largely untapped market for clinical trials, with data showing that the continent has a history of running significantly fewer clinical trials than other regions globally. But Africa has much to offer pharmaceutical companies in trialling new drugs. And the key to opening up the market lies in expertise in managing the supply chain and overcoming the varying regulations across 54 countries. We talk to clinical trial supply chain experts, Oximio, to learn more.
Production of monoclonal antibodies (mAbs) therapies has traditionally been expensive and complicated. Scaling up from discovery to lab scale and then to commercial manufacturing can be streamlined by using a consistent approach. We speak to Dr Hani El-Sabbahy, Advanced Application Engineering Specialist from 3M, to understand more about overcoming problems with scalability and reliability of clarification solutions.
Bottlenecks in harvest clarification caused by intensified upstream processes create challenges in the production of monoclonal antibody (mAb) therapeutics. However, new technologies are enabling an increased yield while reducing the number of steps and resources required in biopharma production. We speak to 3M’s Dr Hani El-Sabbahy to learn more.
The number and complexity of clinical trials is increasing dramatically. While trials tend to enroll fewer patients, those patients are often in remote locations and increasingly prefer to be treated in the home rather than at an investigator site. In addition, the drugs being evaluated often have complicated storage, handling and transportation requirements. Sponsor companies can ensure the success of their clinical studies by partnering with a clinical logistics partner that has comprehensive and demonstrated capabilities in customs clearance, transportation and comparator sourcing.
Risks of water stagnation have increased in the last two years due to buildings being vacated during the global pandemic. Microbial growth has been made more likely in many installations, increasing the potential presence of Legionella and other waterborne pathogens harmful to human health. Dangers are not limited to hospitals, with sites such as office buildings and gyms also susceptible. We speak to experts at Pall International to learn more about the risks from water stagnation and ways to provide immediate protection from harmful bacteria.