Analytical characterization laboratory specializing in small molecule active pharmaceutical ingredients. Employs a wide range of testing services to support your projects over their life cycle (FTIM – Phase III). They offer a unique customer service experience where they are an extension of your program. They amplify your program to the next level by tapping into available technology and innovative ideas while standing on an excellent quality foundation.
Portrett Pharmaceuticals was founded in June 2021. Founder, Kimberly Lupo, had the vision to own her own laboratory while in undergrad. The experience and insight gained from time in the pharmaceutical industry solidified that there was a need for a different type of testing laboratory. Wilmington, NC, and its ecosystem and talent was the perfect place for Portrett to call home.
Kimberly Lupo has over 15 years of experience in the pharmaceutical industry. Serving clients at Metrics Contract Services (Mayne Pharma) for 13 years solidified Kimberly’s desire to work closely with clients to meet their custom contract research needs. Additional experience with IRIX Pharmaceuticals (Thermo Fisher Scientific) and Quality Chemical Laboratories has assisted Kimberly in becoming highly experienced and knowledgeable with the pharmaceutical research industry.
Kimberly earned a Bachelor of Science in Chemistry from UNC Pembroke and a Master of Science in Analytical Chemistry from UNC Charlotte. She completed her Master of Business Administration at Eastern Carolina University. She also obtained her regulatory affairs certification (RAC US) in 2015.
They provide customized analytical testing for their client’s programs at all phases of the process. From method, development to phase-appropriate method validation.
- Routine Testing: Performing quick turnaround on routine testing with the highest quality. Your priorities are their priorities.
- Reference Standard Qualification and Requalification
- Release testing of starting materials, intermediates, and final drug substances
- Complete data packets provided
- Stability storage and testing
- Method Development: Phase-appropriate method development for any tests that their instrumentation supports. Troubleshooting or optimizing a method is a specialty of theirs!
- Develops methods with the final use in mind.
- Method development report and summaries provided.
- Improves and optimizes methods to ensure you are submission-ready
- Validation & Transfers: ICH Q2 phase appropriate validations and method transfers to suit the needs of each project.
- Method Qualifications, Validations, and Transfers for all phases of the program. FTIM (First Time in Man) to Phase III
- Quality oversight from protocol generation to report approvals
- Compendial Testing: Supports compendial testing for USP and EP.
- Excipients, Raw Materials, Ingredients, Drug Substances
- Method verification was performed and documented
- High volume samples
- Instrumentation & Equipment: All instrumentation and equipment are qualified and maintained per cGMPs.
- Agilent 1260 HPLC w/ DAD
- Waters Aquity Arc HPLC w/ DAD
- Agilent 7890 GC w/ Headspace & Direct Inject Capabilities
- Mettler Toledo T9 Karl Fischer
- Waters LC/MS (non-GMP)
- Bruker 600 MHz NMR (non-GMP)
Their mission is to continue to grow by adding additional instrumentation and continue to provide excellent quality to their clients. They hope they will be able to add stability services and ICP/MS to their offerings and establish relationships with the many clients that would benefit from their excellent service and flexibility.
Their team has a lot of experience in this industry, and they are extremely focused on quality. They have regulatory affairs certification which gives them access to a lot of FDA resources that other contract labs may not have. Their quick turnaround time without compromising the quality of their work is another good reason to choose Portrett Pharmaceuticals.