[en] The complexity of biotherapeutics in development continues to increase as our capability in discovery and recombinant technology improves. While safety and efficacy remain the two critical aspects of all therapeutics, ensuring adequate stability is a challenge. Freeze-drying is a commonly-used processing technique to enhance the stability of biotherapeutic products, although the lengthy process time and low energy efficiency have led to the search for, and evaluation of, next-generation drying technologies, including spray freeze-drying and vaccum-foam drying. Both processes result in dosage forms that vary considerably from those produced by lyophilization and possess physical properties that may be deemed superior for their intended applications. (Author)

[en] The pore scale progression of the sublimation front during primary freeze drying depends on the local vapor transport and the local heat transfer as well. If the pore space is size distributed, vapor and heat transfer may spatially vary. Beyond that, the pore size distribution can substantially affect the physics of the transport mechanisms if they occur in a transitional regime. Exemplarily, if the critical mean free path is locally exceeded, the vapor transport regime passes from viscous flow to Knudsen diffusion. At the same time, the heat transfer is affected by the local ratio of pore space to the solid skeleton. The impact of the pore size distribution on the transitional vapor and heat transfer can be studied by pore scale models such as the pore network model. As a first approach, we present a pore network model with vapor transport in the transitional regime between Knudsen diffusion and viscous flow at constant temperature in the dry region. We demonstrate the impact of pore size distribution, temperature and pressure on the vapor transport regimes. Then we study on the example of a 2D square lattice, how the presence of micro and macro pores affects the macroscopic progression of the sublimation front. (Author)

[en] Widespread use of advanced process control allows reduction of costs, by reducing drying time and energy consumption. The “control of the freezing stage” (by forced nucleation) also appears to be beneficial to process intensification, as it can impact the product structure and modify the product resistance to mass transfer. An alternative way to increase the drying rate is the use of organic solvents as they can lead to larger solvent crystals, hence lower product resistance to vapor flow. Atmospheric freeze-drying may be a good alternative to vacuum freeze-drying, as a way of increasing process efficiency. A further improvement can be obtained by combining atmospheric or vacuum freeze-drying with new technologies. A further step towards process intensification is given by continuous plants, as this allows a dramatic increase in throughput and product quality uniformity product. (Author)

[en] Highlights: • Pharmaceutical grade HYNIC-TATE kits compliant with quality control criteria were formulated. • ^99mTc-HYNIC-TATE was successfully prepared with > 95% RCP using the formulated kits. • Radiopharmaceutical was successfully utilized for detection of NETs in patients. - Abstract: AimTo formulate freeze dried cold kits for preparation of ^99mTc-HYNIC-TATE suitable for use at hospital radiopharmacy and establish clinical utility of ^99mTc-HYNIC-TATE prepared using kits for detection of neuroendocrine tumors (NETs).

[en] Model systems for boundary structures and cellular systems, particularly when they are a result of natural simulation experiments, are always valuable for the study of the ''Origins of Life''. Lyophilization of chromoproteinoids - peptide like molecules containing prosthetic groups - leads to the formation of boundary structures

No abstract available

[en] The utilisation of vascularised and free bone autografts remain the goal standard in maxillofacial reconstructive surgery in Malaysia, but the use of freeze dried bone allograft is still widely practiced in many centres with variable results. This study evaluate the effectiveness and clinical efficacy of using radiation sterilised freeze dried bone allografts in oral and maxillofacial reconstructive surgery. The bone grafts were prepared at the Malaysian National Tissue Bank. Seventy eight patients who had undergone oral and Maxillofacial surgical procedures with reconstruction using bone allografts were included in this study. 50 patients were male and 28 patients were female and their age ranged from 14 to 75 years. Forty two patients underwent enucleation of benign cystic lesions in the jaws, 15 patients underwent repair of orbital floor fractures, 6 patients of jaw fractures with partial loss of bone while 8 patients underwent augmentation of depressed cheek bone. Another 4 patients had partial resection of the mandible because of cancer and 3 patients had facial osteotomies. A follow up period of 12 months up to 4 years was carried out. The patients were assessed both clinically and radiologically throughout their follow up visits. Clinical assessment showed no evidence of rejection of the implanted freeze dried allografts. Bone allografts implanted as inlay grafts demonstrated a better clinical performance than onlay grafts and the poorest results were obtained following bridging bony defects in the jaws. Radiation sterilised freeze dried bone allografts produced at the Malaysian National Tissue Bank are bio-compatible, functional, and provide predictable results when applied to selected areas of the facial skeleton

[en] This work includes a series of tests carried out to our Agents of radiodiagnosis use to determine the parameters to follow in order to obtain an adequate lyophilization of them

[en] This study aimed to assess the effects of fresh, thermal drying method (vacuum oven drying), and nonthermal drying method (freeze drying) on the antioxidant activities of leaves and berries of Cayratia trifolia using ferric reducing antioxidant power (FRAP) and 1,1-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH) assays. The total phenolic content (TPC) and flavonoid content (TFC) of the leaves and berries of C. trifolia were also measured. Based on the results obtained, the TPC, TFC, and antioxidant activities of the leaves and berries were arranged in the following order: freeze-dried sample with methanol extraction > vacuum-dried sample with methanol extraction > freeze-dried sample with water extraction > vacuum-dried sample with water extraction > fresh sample with methanol extraction > fresh sample with water extraction. The results showed a significant difference (p<0.05) between the fresh and dried samples. In conclusion, freeze drying was found to be a good method for maintaining TPC, TFC, and antioxidant activities by FRAP and DPPH methods in the leaves and berries of C. trifolia. (author)

[en] There is an increasing demand for a powder soups and sauces composed with lyophylizated meat. Technology of lyophylization is not always accompanied by thermal treatment of raw materials. That is the reason the meat lyophylization process does not ensure as good microbiological quality as is required. Degree of microbiological decontamination and organoleptic properties of lyophilized meat were investigated after radiation treatment