Pharmaceutical Development and Manufacturing Center of Excellence
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.
Course Content Includes
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.
Scientific Discussion Around Patheon Opportunities, the Pharmaceutical
Industry, and An Overview of the Lyophilization Development Process
February 10, 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 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.
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.
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.