Agency: Cordis | Branch: FP7 | Program: BSG-SME | Phase: SME-2013-1 | Award Amount: 1.35M | Year: 2013
Therapeutic antibodies have transformed cancer therapy during the last decade, due to their high selectivity of targeting cancer cells in comparison to standard small molecule chemotherapy. Most recently, the coupling of cellular toxins to therapeutic antibodies has demonstrated an even greater efficacy in the therapy of cancer and the first, highly potent antibody drug conjugate (ADC), Adcetris, was FDA approved in August 2011. All ADCs currently in clinical development are generated by chemical conjugation of small molecule toxins to antibodies. This is an inefficient process, as site and ratio of toxin coupling cannot be controlled. In addition, the chemical conjugation involves chemical modification of potentially functional parts of the antibody. This can have negative effects on stability, specificity, CMC properties and the overall structure of the antibody. All this renders ADC manufacturing highly challenging, complicates regulatory procedures, and adds to development time and costs. The SME consortium has complementary proprietary technologies and proposes to leverage this complementary expertise and know-how for defining novel processes of enzymatically conjugating small molecule toxins to antibodies that allow full control about toxin coupling site and ratio. Due to the high selectivity of enzymatic conjugation and physiologic conjugation conditions, it is expected that more homogeneous ADCs are generated with better CMC properties, higher potency, and at lower cost-of-goods in manufacturing. The consortium members believe that this represents a disruptive technology that will be highly competitive to traditional chemical conjugation, currently dominated by U.S.-based ADC technology companies Seattle Genetics and Immunogen. In addition to novel composition-of-matter IP, important novel know-how for ADC development will be created. Most importantly, better quality and potency of these next-generation ADCs will eventually benefit cancer patients.
Agency: Cordis | Branch: FP7 | Program: CP-TP | Phase: KBBE.2012.3.3-03 | Award Amount: 7.11M | Year: 2012
The European Life science and chemical industries increasingly depend on effi-cient, sustainable, and cost-effective bioprocessing platforms to remain competi-tive. A critical assessment of current bottlenecks during (bio) manufacturing clearly indicates that the recovery and purification of biologicals in large scale in responsible for many inefficiencies. INTENSO proposes an evaluation of the current situation of the downstream processing scenario with the aim of identifying inefficiencies and concomitantly introduce a debottlenecking overarching strategy. The later will be build up on the basis of a multidisciplinary approach, which considers opportunities to im-prove the process technology and underlying chemistry / biology and materials science at the same time. INTENSO will work alongside 4 technological axes, targeting promising and up-coming technologies and tailoring such technologies to the manufacturing of various classes of (bio) products. Intensification of individual unit operations and global process integration, as well as, dovetailing with fermentation / cell cultivation will be employed to the mentioned end. INTENSO will target new classes of (bio) products like Monoclonal Antibodies (Mabs), pDNA (e.g. for genetic vaccination), Virus Like Particles (VLP) or nano-plexes. All the mentioned new products are part of most industrial R&D pipelines and offer an excellent opportunity to introduce innovative bioprocessing. The results of the project are expected to contribute to the understanding of current industrial downstream processing practice, to the definition and alleviation of current inefficiencies, to the development and / or implementation of novel technologies, and to more efficient / sustainable and cost effective (bio) manufacturing. Various technologies will be studied utilizing a nano-to-process strategy so as to introduce integration / intensification during bioprocessing.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.2.3.1-1 | Award Amount: 7.72M | Year: 2012
Background. Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrugresistant gram-negative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial treatment is associated with increased mortality. In this context, the empirical treatment of choice for VAP is unknown. Colistin, and old drug, is now the antimicrobial with greatest in vitro activity against MDR-GNB. However, no randomized clinical trial with colistin has been carried out. Additional aspects of colistin are also not well known, such as the appearance of resistant strains or alterations in the intestinal microbiome during treatment. Furthermore, conventional microbiological techniques take 48 to 72 hours to identify pathogens and determine their susceptibility. This is too long if empiric treatment is inappropriate. Objetives. The overall goal is the optimisation of the treatment of VAP caused by MDR-GNB, by defining a gold standard empiric therapy and reducing the period of time needed for the determination of the etiology and susceptibility of pathogens. Methods. MagicBullet proposes a randomized, open label, multicenter, clinical trial to compare the safety and efficacy of colistin vs. meropenem, both combined with levofloxacin, for empirical treatment of VAP. The pharmacokinetic and pharmacodynamic characteristics of colistin will be determined. Evaluation of the impact of the both treatments in the intestinal microbiome of patients and in the Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrug-resistant gramnegative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial treatment is associated with increased mortality. In this context, the empirical treatment of choice for VAP is unknown. Colistin, and old drug, is now the antimicrobial with greatest in vitro activity against MDR-GNB. However, no randomized clinical trial with colistin has been carried out. Additional aspects of colistin are also not well known, such as the appearance of resistant strains or alterations in the intestinal microbiome during treatment. Furthermore, conventional microbiological techniques take 48 to 72 hours to identify pathogens and determine their susceptibility. This is too long if empiric treatment is inappropriate.
Agency: Cordis | Branch: FP7 | Program: BSG-SME | Phase: SME-1 | Award Amount: 1.32M | Year: 2008
This project proposes a new -highly efficient- method for intracellular protein recovery form yeast electroextraction. Moreover, a novel bio processing strategy will be developed based on its combination with subsequent direct product capture onto a suitable solid phase. Selective recovery of the yeast intracellular soluble proteome will be attempted by permeabilization of cell envelope with high intensity electric field pulses. This treatment as already shown in laboratory experiments leads to a selective release of soluble cytoplasmic proteins, without cell disintegration and with high product yields. The electropermeabilization will be performed in continuous mode under conditions allowing greater selectivity for the targeted species, and limited protease release to avoid product damage. The method will be tested employing several types of commercially relevant yeasts. Sorption is a proven method for efficient product recovery from fermentation liquors or disrupted biomass. The compatibility of the electrically treated feedstock with commercial beaded adsorbents for direct product capture will be assessed, under real process conditions. Operational windows will be defined to allow for product sorption in stirred tank or fluidized bed contactors. Mass transfer properties of the whole system will be explored. Better utilization of total adsorbent ligand sites is expected since less potential interfering substances (nucleic acids, organelles, cell debris) will be liberated. Therefore, a powerful technology for intracellular protein recovery and purification can be envisioned by coupling electroextraction and immediate soluble product sequestration onto a suitable solid phase. Electroextraction will provide a route for more facile, efficient, and economical processing of intracellular bioproducts from yeast fermentations that are valuable for the chemical, food, and pharmaceutical industries.
Biomedal S.L. | Date: 2009-04-17
Pharmaceutical products, namely, products for clinical and alimentary diagnosis specifically for detecting and quantifying the allergens in foodstuff and beverage; Pharmaceutical products for detecting and quantifying gluten in foodstuff and beverage; Products for analytic immunological techniques, namely, medical diagnostic preparations, reagents, assays and test strips for detecting and quantifying gluten and allergens in organic and biological substances.