In 2015, a $1.1 million grant from Golden LEAF Foundation was awarded to East Carolina University (ECU) to develop a laboratory-based education and training network for the pharmaceutical industry. Our team is excited to work with the regional pharmaceutical industry to prepare even more of our graduating students for careers at these companies, collaborate on projects large and small, and to supplement existing workers' knowledge with useful short courses, as well as complement the activities of our community college partners.

During our grant period, we have expanded our laboratory operations footprint, hired two dedicated scientists, quadrupled the number of students enrolled in pharmaceutical skills training courses offered in ECU Chemistry, supported the submission of proposals totaling nearly $7M in external funding requests by ECU researchers, and welcomed over 130 employees for professional development courses.

 

GMP/GLP Courses

The Department of Chemistry offers two GMP-related courses. CHEM 7522 is designed for the graduate student in the chemical, biological, or biomedical sciences, and CHEM 4522 is targeted to the advanced undergraduate student who has excelled in Quantitative and Instrumental Analysis (CHEM 2250, 2251). The courses cover regulations, laws, and skills involved in good laboratory (GLP) and current good manufacturing practices (cGMP).

Course content includes:

  • Development of cGMP for Drug Products and Active Pharmaceutical Ingredients
  • Reading and understanding Code of Federal Regulations for Drugs (Part 210) and Finished Pharmaceuticals (Part 211)
  • Validation (DQ, IQ, OQ, PQ) for different areas of pharmaceutical development, production, and automation/documentation (CFR 211 Part 11)
  • Stability testing for drug products and critical areas in the drug development process (Investigational New Drug (IND) through New Drug Application(NDA))
  • Application of statistical methods to compliantly accept/reject data
  • Performing and compliantly documenting basic laboratory techniques, including appropriate calibrations pH determinations, balance determinations, and tablet die size and gauge
  • Researching and performing current USP procedures and determining adherence to specifications for compendial raw materials
  • Performing and documenting Stability HPLC Assay, Head Space GC analysis for organic volatile impurities, Dissolution Analyses, and an HPLC ‘mini-validation’ for a cough-cold product
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Short Courses

We offer a variety of half- and full-day short courses on topics relevant to the pharmaceutical industry and beyond. These can be tailored to your company's needs, and offered on or off site. Contact Jack Pender with your custom training needs.  

Recent short course topics include:

  • HPLC: System Suitability, Quantitation, and Data Reliability
  • HPLC: Back to Basics
  • Applying Building Block Innovations to Ensure Drug Product Quality (Chromatography)
  • Particle Size, Shape, and Chemical Identification
  • OOS: Don't Shoot the Messenger
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Analytical Services

Our laboratories are well-equipped with modern analytical instrumentation. Services are available on an as-needed basis, or can be set up more routinely. We are responsive to requests from government, academia and industry.

Equipment includes:

  • Waters Acquity H-Class Ultrahigh Performance Liquid Chromatography (UPLC)
  • Thermo Fisher Scientific Charged Aerosol Detector
  • Waters UPLC / Micromass Quadrupole-ToF MS
  • Agilent 7900 ICP-MS
  • Bruker Autoflex Speed ToF MS
  • Sciex 3200 Triple Quadrupole MS
  • Thermo Fisher Scientific Nicolet is50 FTIR/Raman/NIR Spectrometer
  • TA Instruments TAM IV Microcalorimeter
  • TA Instruments Nano Differential Scanning Calorimeter
  • Karl Fischer moisture titration (volumetric and coulometric)
  • Headspace GC/FID
  • DryLab 4 Chromatography Modeling software
  • Dissolution Apparatus 2

Fees
Our center typically charges for consumables, instrument time, and data analysis time. Depending on the size of the project, these prices may change based on the number of samples or complexity of the method. Savings may be realized if measurements are routinely made or, if appropriate, users are trained.  Please contact Dr. Kimberly Kew (LC/MS, MALDI/MS) or Dr. Jack Pender (Spectroscopy, Chromatography, ICP/MS) to discuss a scope of work and to have a custom quote created.  

Recruitment and Networking
The Department of Chemistry and the Pharmaceutical Development and Manufacturing Center of Excellence are committed to connecting regional employers with excellent candidates for internships and permanent jobs. Students nearing graduation are eager to network with potential employers. The university's Career Center coordinates career fairs several times per year. Additionally, we are happy to host employers in Chemistry for presentations, panel interviews, informal gatherings, or any other capacity that helps companies identify their next great employees.