Resnik M.,University of Ljubljana |
Kerc J.,Lek Farmacevtska Druzba D.d
Farmacevtski Vestnik | Year: 2010
Pharmaceutical industry is known to be one of the most regulated production environments because of its direct effect on human health. Microbiological quality control of pharmaceutical products contributes a huge part to this whether it is the production environment that mostly affects them or the substances which are used in the products. With quality assurance as the first approach of performing good manufacturing practice in today's production the aim is to prevent microbial contamination in every product. Nowadays pharmaceutical companies are dealing with pretentious implementation of harmonised regulations which would offer even better basis for product's quality. Besides microorganisms found in pharmaceutical industry, factors affecting microbial contamination, microbiological control and different tests are reviewed in the article.
Cegnar M.,Lek Farmacevtska Druzba d.d. |
Kerc J.,Lek Farmacevtska Druzba d.d.
Farmacevtski Vestnik | Year: 2012
Nanotechnology is changing the way of traditional treatment, since the first nanotechnology products already entered the common clinical use. More than thirty nanomedicines are found on the EU and/or USA market. These include liposomes, nanoparticles, nanocrystals and polymer therapeutics mainly related to anti-infectives, anti-neoplastic and immuno-modulating agents. Beside benefits nanomedicines bring also treats due to their inherent properties adversely affecting the safety and quality of these drugs. Currently, there are no regulatory guidelines specifically tailored to nanomedices. The need for implementing specific guidelines has prompted regulatory authorities to establish groups of experts to gain an adequate knowledge in this filed. Clear regulatory status is one of the key parameters hindering investments in nanotechnology in pharmaceutical industry. Most knowledge comes from academia. The pharmaceutical industry is more conservative and tracks the progress before investing. Despite the initial scepticism nanotechnology is paving the way to enter industry mainly through the emergence of specialized small and "spin-off" companies, or through licensing agreements and cooperation with smaller nanotechnology partners. The global nanotechnology healthcare market is forecasted to grow exponentially. Academic and research institutions, regulatory authorities, pharmaceutical industry and other stakeholders will have to work closely to reap the benefits that are offered by nanotechnology and bypass all the threats.
Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: NMP.2011.1.2-2 | Award Amount: 11.03M | Year: 2012
The objective of the ALEXANDER project is the identification of novel strategies (e.g., proteolytic enzyme strategy, thiomer strategy, zeta potential changing systems, SNEDDS strategy) and the optimization of existing strategies (e.g., disulfide breaking strategy and slippery surface strategy) for the efficient transport of nanocarriers through the mucus gel layer (e.g., intestinal, nasal, ocular, vaginal, buccal, pulmonary). In particular, R&D activities will be focused on the synthesis of functionalized nanocarriers capable of permeating the mucus gel layer and delivering their therapeutic payload to the epithelium. The nanocarriers will be characterized with respect to their physicochemical properties, ability to cross the mucus gel layer, in vitro and in vivo cytotoxicity. The potential of the developed nanocarriers as delivery systems for mucosal administration of macromolecules will be demonstrated via the oral delivery of peptides, oligosaccharides and oligonucleotides and the nasal delivery of a plasmid encoding for an antigen.
Agency: European Commission | Branch: H2020 | Program: IA | Phase: BIOTEC-4-2014 | Award Amount: 10.57M | Year: 2015
The scope of the project is the optimization of downstream process (DSP) for the production of Biopharmaceuticals. Biopharmaceuticals have been successfully used as efficient therapeutic drugs for many pathophysiological conditions since the first recombinant product, insulin, was approved in 1982. Despite its efficacy, accessibility is still limited due to extremely high costs. In the production chain, capturing and purifying still represents a major bottleneck. Consequently, improvements in this area produce substantial cost reductions and expand patients accessibility to highly efficient drugs. Another aim of this action is to cope with the changing manufacturing demands, by lowering its environmental footprint and moving to more sustainable technologies. This proposals main objective is to implement a fully integrated manufacturing platform based on continuous chromatography in combination with disposable techniques for all unit operations of the DSP sequence for biosimilar monoclonal antibodies and derivatives thereof. The action encompasses the entire DSP sequence. We will implement alternative technologies for primary separation, such as flocculation or tangential flow filtration. The expected outcome is a reduction in the size and number of downstream unit operations and the elimination of centrifugation. Alternative approaches to the batch process for the capture step, such as continuous chromatography, will be evaluated in order to improve the efficiency and lower the need for expensive resin volume. Additionally precipitation utilization will be evaluated as an approach to replace protein A chromatography as capture step. A disposable continuous chromatography system will be developed together with novel analytical tools and sensors. Since single-use disposable systems can substitute the extensive use of resources (water) and significantly reduce the overall utility needs, the whole DSP sequence will be carried out on disposable technology (PAT).