Observations from the European Federation of Pharmaceutical Sciences (EUFEPS) conference in 2021

The conference was divided into three days; the first day included research presentations and panel discussions, the second day poster presentations and the third day research presentations and summary. EUFEPS is a large conference, thus, covers a broad range of topics. New innovations and research include inhalation, pharmacogenomics, process technology, process design, regulatory science, veterinary medicine, just to mention some of the themes. Two topics parallelly presented governed the possibility of choice, where one could jump between lectures without disturbance, and listen to preferred speaker and/or topic. Lectures of interest include and are summarized below:

“Design of Experiment (DOE) based optimization and in-vitro cell culture studies of piroxcam loaded hybrid nanoparticles for prostate cancer” Ceyda Tuba Sengel-Turk, Ankara University, Turkey

The seminar was about their research of entrapment of Piroxcam into core-shell lipid polymer hybrid nanocarriers and evaluation of its anticancer efficacy on PC3 prostate cancer cells. They used the Box Behnken design to evaluate critical formulation factors for quality like encapsulation efficiency and mean particle size. The Designed experiments found an optimized formulation of Piroxcam loaded hybrid nanoparticles, which was very effective in cell culture studies compared to the pure drug regarding cytotoxic and apoptotic effects. They will conduct further studies to understand the potency of the optimized formulation for prostate cancer treatment.

“Particle-based products: measurements for product development, upscale manufacturing quality control, and regulatory approval.” Dr Caterina Minelli, National Physical Laboratory, UK.

This seminar highlighted the lack of validated methods and standards for product development, upscaling, QC, and regulatory approval. The talk was mainly about some of the work National Physical Laboratory has done in the area. One case study was done together with Malvern Panalytical, where they collaborated on validating the DLS instrument for measuring nanoparticle number concentration. They also work with method development and can help companies with methods for particles measurements. One example mentioned was OxSonic Therapeutics, which required particle concentration and size to assess variability between batches. NPL delivered a method based on analytical photo-centrifugation (DCS) to measure particle size and concentration. Another example of their work was with Astra Zeneca for method selection and batch comparison. They assess methods for measuring particle size and find methods for scaling up manufacturing and methods suitable for QC for manufacturing.

“Global Health- Improving Pharmaceutical Economics for All” Dr Miya Bowers, Bill & Melinda Gates Foundation, USA

This seminar was about projects within Global Health where they have projects working on making drugs and vaccines more accessible and affordable for low-income countries. They mentioned several projects. One of the projects works with a novel drug delivery system for long-acting oral delivery technologies. Another project is to establish the contraceptive Sayana press. It has benefits such as three months of contraceptive protection with an easy administration format that the user could do. There is lower shipping and storage, no need for injection supplies, and it is accessible outside health clinics. In that project, they have introduced novel pricing agreements a 1 dollar/dose and are working with the acceptance for self-injection by users. They are also looking into the global health supply chain, where they collect data to see how humidity and temperature vary during international shipments to the hospitals. They have installed sensors on air and sea shipments from Asia and Europe to East and West Africa to collect the data. Some initial results showed that on an air shipment from Belgium to Mozambique, the temperature range was between 5 and 45 °C. For shipments in-country with trucks, they tracked temperatures up to 60 °C with 100 % humidity. These are important results for global health and the continued development of drugs to ensure quality when many drugs are sensitive to temperature and humidity.

“Continuous Manufacturing of a Pharmaceutical Coated Tablet by Direct Compression: Experiences from Commercial Operations” Stephen Conway, MSD

This seminar focused on MSD’s approach to continuous manufacturing for oral solid drugs. By implementing continuous manufacturing (CM) in the manufacturing attractive benefits include high assurance on drug quality, agility to meet changing patient demands, lower cost and lower production time. Important factors that govern CM include fully functional sites with necessary resources, clear risk-based process models, standard operating procedures (SOP) up to date, monitoring of critical process variables. In summary, MSD managed to fully integrate CM line alongside existing batch operations.  Novel control strategy elements such as predictive real time dispatch (RTD), in-line monitoring by NIR and tablet attribute measurements permitted real time release of coated tablets by direct compression.