The Design, Development and Scale-Up of Safe Chemical Processes and Operations

2 - 4 October 2013 • Chilworth Global, Princeton, NJ, USA

Dr Vahid Ebadat, Chilworth Technology Inc.

Dr. Swati Umbrajkar

Dr Will Watson, Scientific Update

http://ecampaign.scientificupdate.co.uk/index.php?action=social&c=17c276c8e723eb46aef576537e9d56d0.882

Developing safe processes is of paramount importance to any chemical company. Exothermic chemical reactions in batch and semi- batch processes can result in serious injury to people and plant if they get out of control. Results of thermal runaways include violent loss of containment, possibly explosion and the release of flammable or toxic materials to the environment.
Employers are bound by Health & Safety legislation to ensure the safety of their employees and those outside their employment who might be affected by their activities. Chemical manufacturers must therefore be aware of all potential dangers in their processes and take steps to eliminate them. The best approach is to design safety into the process from the start.
This seminar is designed to enhance the awareness of chemists and engineers regarding hazard issues. Utilizing the expertise of the chemists and chemical engineers at Chilworth Global and Scientific Update, it will consider hazard control of new chemical processes throughout their development cycle: from early development through to full-scale production. Hazards can often be eliminated by appropriate choice of reagent or synthetic route at the R&D stage. Where this is not possible, techniques exist to quantify the hazards so that robust engineering solutions can he applied in production.

Who Should Attend?

• R&D and Process Development Chemists, Chemical Engineers, Managers and anyone whose responsibilities include safety or risk assessment of chemical processes or building safety into chemical process scale-up.

Visit SCIENTIFIC UPDATE website for complete course information.

http://ecampaign.scientificupdate.co.uk/index.php?action=social&c=17c276c8e723eb46aef576537e9d56d0.882

SciClone Gains China Rights to Zensun’s Heart Failure Drug

may19, 2013

SciClone Pharma in-licensed China rights to a heart failure drug from Zensun (Shanghai) Science & Technology Co. SciClone, which is headquartered in the US, usually markets western drugs in China. This time, the company has acquired a China-developed drug for China.

 

The deal gives SciClone exclusive rights to market Neucardin™, a novel treatment for chronic heart failure, in China, Hong Kong and Macau. Zensun filed for approval of Neucardin with the CFDA last year

NEUCARDIN^TM is a genetically engineered recombinant peptide fragment of neuregulin-1 (β2a isoform). It is expressed in E.coli , lyophilized for storage and used for the treatment of moderate to severe heart failure.

Mechanisms : It has been shown that neuregulin-1 is importantly involved in development, differentiation and function of myocardial cells. Based on research on molecular and cellular level, Zensun found that NEUCARDINTM couldattenuate myofibrillar disarray in impaired myocardial cells and strengthen the intercalated disc connections between them. In addition, in vivo administration of NEUCARDINTM greatly reduced myocardial cell damage induced by ischemia, hypoxia or viral infection, allowing repair of sarcomere structure, with improvement in cardiac performance, hemodynamics and survival.

Indications : NEUCARDIN^TM is indicated for the treatment of patients with intermediate to advanced heart failure and dilated cardiomyopathy.

Pharmacological Action : Using various animal models, including (1) rat sub-acute and chronic heart failure, (2) mouse viral myocarditis, (3) rat toxic myocarditis induced by adriamycin, and (4) dog congestive heart failure caused by constriction of inferior venue cava, it has been demonstrated that NEUCARDIN^TM improves impaired myocardial structure, decreases the extent of ischemia injury, and improves heart function and hemodynamics. This results in enhanced survival in these animal models.

Safety : Safety pharmacology studies indicate that NEUCARDIN^TM has no adverse effects on cardiovascular or respiratory system function in normal monkeys. Acute toxicity studies in mice showed that the minimum fatal dose was 3000 times the clinical equivalent dose. Safety evaluations in monkeys after administration of multiple doses of NEUCARDIN^TM revealed that a high dosage (above the therapeutic dose) could cause some local microcapillary vessel leakage, but no significant side effects had been found with doses in low to moderate ranges, indicating a safe therapeutic dosage range.