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Pharmaceutical Development and Manufacturing Center of Excellence

Contact Us

Jack E. Pender, PhD
Principal Research Scholar
Director, Pharmaceutical Training and Services
(252)328-9711

Kim A. Kew, PhD
Senior Research Scholar
Director, Mass Spectrometry Services
(252)328-9791

Allison S. Danell, PhD
Associate Professor
Lead Principal Investigator
(252)328-9766

Ted Morris, PhD
Associate Vice Chancellor, Innovation and Economic Development
Principal Investigator
(252)737-1341

PDM CoE Small


In 2015, a $1.1M grant from Golden LEAF Foundation was awarded to 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.

We invite you to navigate via the links below to learn more about how we can work together!

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). This course is taught by Drs. Keith Holmes and Jack Pender, with significant contributions from regional industry partners. The importance of documentation and data integrity is stressed in these courses. Typical laboratory notebooks require from 130 – 160 pages of documentation (all figures/data tables properly identified and all data taped in and initialed/dated per GMP requirements).

CHEM 4522 can count towards the BS Chemistry and BS Biochemistry majors. CHEM 7522 may be used towards the MS Chemistry, including the Professional Science Masters, the MS Biomedical Engineering, and the Interdisciplinary Doctoral Program in the Biological Sciences. We also welcome qualified students from other programs wishing to take these courses as electives.

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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

Email Dr. Holmes with any questions regarding registration.

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.  

Upcoming Events

TBA

Recent Events

A Scientific Discussion Around Patheon Opportunities, the Pharmaceutical Industry, and An Overview of the Lyophilization Development Process
February 10, 2017, ECU Science and Technology Building

Recent Advances in Capillary Electrophoresis, followed by Targeted and Unknown Lipid Analysis
February 15, 2017, ECU Science and Technology Building

HPLC: System Suitability, Quantitation, and Data Reliability
January 6, 2017, ECU Science and Technology Building

HPLC: Back to Basics
December 16, 2016, ECU Science and Technology Building

Applying Building Block Innovations to Ensure Drug Product Quality (Chromatography)
August 9 (Greenville) and August 10 (Wilmington), 2016

Particle Size, Shape, and Chemical Identification
July 13, 2016, ECU Science and Technology Building

OOS: Don't Shoot the Messenger
March 3, 2016, ECU Heart Institute

Our laboratories are well-equipped with modern analytical instrumentation. Services are available on an as-needed basis, or can be set up more routinely. Drs. Kew and Pender are here to learn more about the questions you are asking so experiments can be designed to offer you answers, whether you need test results or a new method. For example, our UPLC is set-up for method development with 9 mobile phase lines and a 4-column switching station. We can also provide additional help with data interpretation or statistical analysis. 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

Feel free to ask about other instrumentation which may be available at ECU! Please see our Fees section to learn more about costs and methods of payment. If you are interested in submitting an external proposal for funding, please review the section on Proposal Submission Support to read about how we can assist.

 

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.  

For internal users, invoices can be generated and easily processed by Interdepartmental Transfer (IDT). For external users, an analytical services agreement can be executed at ECU and invoices sent to your company.

Representative Mass Spectrometry Services Pricing List

Personnel are available to support you as you construct proposals to submit for external funding. Drs. Danell, Kew or Pender can meet with you to discuss specific aims and collection of preliminary data. Collaborator roles and appropriate salaries/fees, as well as F&A, also can be discussed at these meetings so you can draft a thorough and accurate budget. A Facilities Description is linked below for your convenience, as are examples of a letter of support and biosketches. Please contact us regarding how we can help you craft a strong and competitive proposal.

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.  

  • Current students may complete an internship during the regular academic year or over the summer. Students may earn ECU CHEM course credit by working with their internship supervisor to complete an internship agreement. ECU faculty Allison Danell is available to arrange for undergraduate intern placement, and Yu "Frank" Yang serves to coordinate graduate student interns.
  • 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.

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