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Raleigh, NC, United States

Patheon Inc. is a pharmaceutical company, incorporated in Canada with its corporate head offices in Durham, North Carolina, that provides contract development and manufacturing services of prescription and over-the-counter pharmaceutical products for approximately 300 pharmaceutical and biotechnology companies.Patheon's competitors in the contract manufacturing marketplace include Baxter and Cardinal Health, both based in the USA.In 2008, the company won the European Outsourcing Award in the category of Most Effective Scale-Up and Technical Transfer award. Wikipedia.


Carr G.,Patheon
Cleanroom Technology | Year: 2013

Contract manufacturer Patheon provides the highest quality products and services to around 300 leading pharmaceutical and biotechnology companies. At Pantheon, the preferred method is to take and test swabs rather than rinsates as the latter tend to be more dilute whereas the swabs give higher concentrations. The analytical procedures generally employed are high performance liquid chromatography (HPLC), ultra performance liquid chromatography (UPLC), or liquid chromatography mass spectrometry (LC-MS). At Patheon, LC-MS is used most of the times. LC-MS is capable of detecting compounds in trace amounts it has the advantage of showing up certain impurities and degradation products. For example, it enables techniques to be developed for dealing with categories of impurities with limits that are below the detection capabilities of HPLC, such as genotoxic impurities. In addition, it provides a tool for ID of new impurities that may turn up during stability studies. Source


Huynh H.T.,University of Queensland | Tran T.T.B.,University of Queensland | Chan L.C.L.,University of Queensland | Chan L.C.L.,Patheon | And 2 more authors.
Applied Microbiology and Biotechnology | Year: 2014

The phenomenon of the cell density effect is not readily explained by an obvious nutrient limitation, and a recent study has suggested that for recombinant Autographa californica multiple nucleopolyhedrovirus (rAcMNPV)-infected Sf9 cells, a drop in messenger RNA (mRNA) levels may be sufficient to explain the cell density effect for this system. The current study aims to investigate the response in cell-specific yields (viral DNA (vDNA), LacZ mRNA and β-galactosidase (β-Gal) protein) with increasing infection cell density (ICD) for rAcMNPV-infected Hi5 cells, where the rAcMNPV expresses the β-Gal gene under control of the polyhedral promoter. Hi5 cells in suspension culture of Express Five® medium were synchronously infected with a rAcMNPV at multiple ICDs between 0.5 and 6 × 106 cells/mL and a multiplicity of infection of 10 plaque-forming units (PFU)/cell either in the original or fresh medium conditions. There were negative correlations between the three key virus infection indicators (vDNA, mRNA and β-Gal) and the peak cell density (PCD). However, unlike infected Sf9 cells, the yield decline started at the lowest PCD investigated (0.6 × 106 cells/mL). Generally, the yield decline with increasing PCD was most pronounced for β-Gal followed by mRNA and was more moderate for vDNA. The decline was significantly reduced but not totally arrested when fresh medium replacement was used. The results suggest that the reduction in recombinant protein-specific yields at high PCDs is associated with limitations during the up-stream processes of replication and transcription rather than entirely caused by limitations during translation. In addition, low production rates at late infection stages of moderate to high ICDs are a probable cause of the cell density effect. © 2014, Springer-Verlag Berlin Heidelberg. Source


Qiao M.,University of Western Ontario | Zhang L.,University of Western Ontario | Ma Y.,University of Western Ontario | Zhu J.,University of Western Ontario | Chow K.,Patheon
European Journal of Pharmaceutics and Biopharmaceutics | Year: 2010

An electrostatic dry powder coating process for pharmaceutical solid dosage forms was developed for the first time by electrostatic dry powder coating in a pan coater system. Two immediate release coating compositions with Opadry® AMB and Eudragit® EPO were successfully applied using this process. A liquid plasticizer was sprayed onto the surface of the tablet cores to increase the conductivity of tablet cores to enhance particle deposition, electrical resistivity reduced from greater than 1×10 13Ωm to less than 1×10 9Ωm, and to lower the glass transition temperature (T g) of the coating polymer for film forming in the pan coater. The application of liquid plasticizer was followed by spraying charged coating particles using an electrostatic charging gun to enhance the uniform deposition on tablet surface. The coating particles were coalesced into a thin film by curing at an acceptable processing temperature as formation was confirmed by SEM micrographs. The results also show that the optimized dry powder coating process produces tablets with smooth surface, good coating uniformity and release profile that are comparable to that of the tablet cores. The data also suggest that this novel electrostatic dry powder coating technique is an alternative to aqueous- or solvent-based coating process for pharmaceutical products. © 2010. Source


Park R.M.,U.S. National Institute for Occupational Safety and Health | Stayner L.T.,U.S. National Institute for Occupational Safety and Health | Stayner L.T.,University of Illinois at Chicago | Petersen M.R.,U.S. National Institute for Occupational Safety and Health | And 4 more authors.
Occupational and Environmental Medicine | Year: 2012

Objectives: Prior investigations identified an association between airborne cadmium and lung cancer but questions remain regarding confounding by arsenic, a well-established lung carcinogen. Methods: A cadmium smelter population exhibiting excess lung cancer was re-analysed using a retrospective exposure assessment for arsenic (As), updated mortality (1940-2002), a revised cadmium (Cd) exposure matrix and improved work history information. Results: Cumulative exposure metrics for both cadmium and arsenic were strongly associated making estimation of their independent effects difficult. Standardised mortality ratios (SMRs) were modelled with Poisson regression with the contribution of arsenic to lung cancer risk constrained by exposure-response estimates previously reported. The results demonstrate (1) a statistically significant effect of Cd independent of As (SMR=3.2 for 10 mg-year/m 3 Cd, p=0.012), (2) a substantial healthy worker effect for lung cancer (for unexposed workers, SMR=0.69) and (3) a large deficit in lung cancer mortality among Hispanic workers (SMR=0.27, p=0.009), known to have low lung cancer rates. A supralinear dose-rate effect was observed (contribution to risk with increasing exposure intensity has declining positive slope). Lung cancer mortality was somewhat better predicted using a cadmium burden metric with a half-life of about 20-25 years. Conclusions: These findings support an independent effect for cadmium in risk of lung cancer mortality. 1/1000 excess lifetime risk of lung cancer death is predicted from an airborne exposure of about 2.4 μg/m 3 Cd. Source


Winkler G.C.,Novartis | Barle E.L.,Novartis | Galati G.,Patheon | Kluwe W.M.,Novartis
Regulatory Toxicology and Pharmacology | Year: 2014

There is no nationally or internationally binding definition of the term "cytotoxic drug" although this term is used in a variety of regulations for pharmaceutical development and manufacturing of drugs as well as in regulations for protecting medical personnel from occupational exposure in pharmacy, hospital, and other healthcare settings. The term "cytotoxic drug" is frequently used as a synonym for any and all oncology or antineoplastic drugs. Pharmaceutical companies generate and receive requests for assessments of the potential hazards of drugs regularly - including cytotoxicity. This publication is intended to provide functional definitions that help to differentiate between generically-cytotoxic cancer drugs of significant risk to normal human tissues, and targeted cancer therapeutics that pose much lesser risks. Together with specific assessments, it provides comprehensible guidance on how to assess the relevant properties of cancer drugs, and how targeted therapeutics discriminate between cancer and normal cells. The position of several regulatory agencies in the long-term is clearly to regulate all drugs regardless of classification, according to scientific risk based data. Despite ongoing discussions on how to replace the term "cytotoxic drugs" in current regulations, it is expected that its use will continue for the near future. © 2014 Elsevier Inc. Source

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