Alexander de Simone

Senior Validation Specialist at LTS - Lohmann Therapy Systems

Alexander De Simone is a Senior Validation Specialist at LTS - Lohmann Therapy Systems, with experience dating back to July 2019. As an Independent Consultant since February 2016, Alexander has provided guidance and support for biopharmaceutical validation and manufacturing facility campaigns. Prior roles include Quality Control Manager and Method and Process Validation Manager at Hemispherx Biopharma, Inc., where responsibilities encompassed developing protocols for process validation in alignment with FDA guidelines. In earlier positions, Alexander served as Quality Control Supervisor Biochemistry and Quality Control Biochemist, overseeing stability and release assays. Alexander began a career as a Legal Assistant at Miller, Platt, De Simone and Galarce, conducting research and interfacing with clients. Alexander holds a Bachelor of Arts in Biochemistry from Cornell University (2004-2008).

Location

Caldwell, United States

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LTS - Lohmann Therapy Systems

LTS Corp is the US-based subsidiary of Lohmann Therapie Systeme whose headquarters are in Andernach, Germany. LTS’s research and development focuses on two new technologies to complement and expand the potential of alternative drug delivery systems. In addition to the development of LTS Transdermal and LTS Oral Thin Film technologies, the company also develops innovative microneedle and the ‘active LTS Transdermal’ technology. LTS Microneedles that are long enough to penetrate the outer layer of skin but too short to irritate nerves and blood vessels. They can be used to inject active substances with larger molecules into the skin, an application that is largely pain-free. Microneedles create tiny holes in the outermost layer of skin, which significantly increases the rate at which the active substance is absorbed. LTS is currently researching a number of different microneedles made from different materials and with different gauges, designs and sizes for a wide range of applications.