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Quality Standards for 14C API for use in human clinical studies
I Shaw, G Johnston, K Dare, D Dams

The Good Manufacturing Practice (GMP) state that the active pharmaceutical ingredient (API) intended for use in early stage clinical trials should be of "suitable" quality. The Clinic Ready quality standard ensures that the API is synthesised with all the appropriate documentation to facilitate QP release of the final IMP for guman clinical dosing.

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Microwave chemistry in SiC Reaction Vials
D. Obermayer, B. Gutmann, B. Reichart, C. O. Kappe

Using novel SiC-technology to mimic conventional heated autoclave experiments.

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Organic azide synthesis in microreactors: from optimization to lab scale production
Pieter J. Nieuwland, Bo Hanssen, Kaspar Koch, Paul Janssen, Marielle M.E. Delville, Anton Lunshof and Floris P.J.T. Rutjes

The formation of benzyl azide by diazotransfer to benzyl amine was screened and subsequently scaled up using continuous flow chemistry.

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Automated Sample Pretreatment of Environmental
Bernard Sheldon,1 Rosanne Slingsby,1 and Rida Al-Horr2

Matrix elimination is a method of sample preparation that removes certain matrix species from a sample, typically by specifically binding matrix species to a solid phase. Interfering compounds can be removed before the analyte determination, thus improving the quality of results as well as lengthening the lifetime of consumables such as columns.

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Five noncovalent peptidic ligands show different affinity rankings in solution and gas phase
Andrey Dyachenko , Michael Goldflam , Marta Vilaseca , Ernest Giralt

Stability of noncovalent complexes of VEGF protein with 5 peptidic ligands is studied. Experiments were conducted in solution (NMR CSP, ITC) and in gas phase (CID TOF MS). Each ligand differs from others in chirality of one amino acid. It was shown, that trend of stability of the studied noncovalent complexes is reversed in the gas phase relatively to the solution. An explanation of this behavior is presented.

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Study of volumetric oxygen transfer coefficient in a Taylor vortex flow bioreactor
Patrícia Ap. Santiago, Cláudio A. T. Suazo, Roberto C. Giordano

An inadequate transfer of oxygen can lead to rapid changes in cell physiology, metabolism, and cell death. In this work, the KLa is evaluated in a Taylor vortex flow bioreactor and a mass transfer correlation is proposed. The experimental conditions employed were: rotational Reynolds number between 244 and 2928, airflow rates varying from 80 mL.min-1 to 550 mL.min-1 and used culture medium DMEM.

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Hyperbaric Bioreactors use with Yarrowia Lipolytica Cultures: Cellular Adaptation to Hyperbaric Conditions
Marlene Lopes, Nelma Gomes, Manuel Mota, Isabel Belo

In this work, a pressurized bioreactor was used for Y. lipolytica batch cultivation under increased air pressure from 1 bar to 6 bar. Cell growth was strongly enhanced by the pressure rise. The increase of oxygen availability caused the induction of the antioxidant enzyme SOD. The pre-growth of Y. lipolytica under increased pressure conditions did not affect the lipase production ability of the cells.

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Adaptive control of glycerol & methanol feeding in recombinant Pichia pastoris cultures: Impact on antibody titre
Filipe Ataíde, Ana Raquel Ferreira, João J. Clemente, António E. Cunha, Rui Oliveira

Pichia pastoris processes for heterolougous protein expression are typically run in three phases: a batch phase, an exponential feeding fed-batch phase and a long oxygen transfer limitation (OTL) phase. The final protein titre is often limited by the oxygen availability in the OTL phase. Here a direct adaptive controller is designed for the OTL phase. The controller was validated in pilot P. pastoris cultivations expressing a single chain antibody fragment (ScFv). This work shows that the propos

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Scalability of heterogeneous MW-heated processes
Mark H.C.L. Dressen, Bastiaan H. P. van de Kruijs, Jan Meuldijk, Jef A. J. M. Vekemans, Lumbertus A. Hulshof

The combination of flow chemistry and microwave heating offers a unique opportunity to scale out heterogeneous microwave-assisted organic reactions. The feasibility of this setup is depending on the presence of a microwave effect, safety issues and energy efficiency.

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