Partnership with Eastern Region Pharma Center
Overview
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.
Golden LEAF Foundation awarded another $1.9M to ECU in 2020 to further build on this success through creation of the Eastern Region Pharma Center.
We invite you to navigate via the links below to learn more about how we can work together!
The Greenville NC MSA is the Active Site for Pharmaceutical Manufacturing. We are proud of our 50 year history of manufacturing pharmaceuticals, and that is not by chance. We have abundant water, concierge permitting, a trained workforce, and pharma-specific training at Pitt Community College and ECU that was designed and enhanced over the years by and for our pharmaceutical companies. In eastern NC, there are over 9000 employees working directly in pharma manufacturing, and there has been over $3 billion in investment. Our largest pharma manufacturers, Thermo Fisher Scientific and Mayne Pharma, both expanded in the past 4 years, creating over 500 jobs and investing over $250 million. Come be a part of our Active Site!
GMP 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 3250, 3251). 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 6622 may be used towards the MS Chemistry, including the Professional Science Masters, the MS Biomedical Engineering, and the Interdisciplinary Doctoral Program in Biology, Biomedicine, and Chemistry. We also welcome qualified students from other programs wishing to take these courses as electives.
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.
Short Courses and Training
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 Events
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- 2nd Annual ECU Spring Break 2020 Pharma Conference
March 10th and 11th, 2020, ECU Science and Technology Building - Quantitative High Performance Liquid Chromatography (HPLC) for Beginners with Lab
July 30th and 31st, 2019, ECU Science and Technology Building - Quantitative High Performance Liquid Chromatography (HPLC) for Beginners with Lab
January 3rd and 4th, 2019, ECU Science and Technology Building - Quantitative High Performance Liquid Chromatography (HPLC) for Beginners with Lab
March 6th and 7th, 2018, ECU Science and Technology Building - High Performance Liquid Chromatography Laboratory: Principles and Practice
July 25th and 26th, 2017, ECU Science and Technology Building - 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 BuildingHPLC: 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
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. Dr. Pender and Nicholas Schaaf 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.
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 Nicholas Schaaf or Dr. Jack Pender(Spectroscopy, Chromatography, ICP/MS) to discuss a scope of work and to have a custom quote created.
Elemental Analysis Request (PDF)
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.
Proposal Submission Support
Personnel are available to support you as you construct proposals to submit for external funding. Mr. Schaaf or Dr. 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.
Recruitment and Networking
The Department of Chemistry and the Eastern Region Pharma Center 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. Students should contact the undergraduate or graduate program directors in Chemistry.
- 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.
- 2nd Annual ECU Spring Break 2020 Pharma Conference