Q4 2012 Company News
FDA Inspection for Compliance with GLP Regulations
Q4 2012 – On September 20, 2012, an investigator from the FDA visited MicroConstants’ San Diego facility for a routine inspection to assess our overall compliance with Good Laboratory Practice (GLP) regulations. The five-day inspection took place across the entire facility. Several method validations, three sample analysis projects, and a pharmacokinetic analysis report were selected to be investigated in more detail, with the inspector carrying out detailed inspections of the equipment used in each. Following the extensive evaluation, the investigator reported zero findings, observations, or recommendations.
Read the news release.
Client Survey Results
2012 Client Surveys Reveal 100% Satisfaction
Every year, we send surveys to all our clients to measure their level of satisfaction and request feedback on ways we can improve. Our latest survey wrapped up in November and here are the results…
- 100% of respondents said they are confident or very confident in the quality of data and results provided.
- 100% are satisfied with the overall quality of work produced.
- 100% would or already have recommended MicroConstants to a peer or industry colleague. Their top reasons for doing so included excellent communication, satisfaction with deliverables, and high quality data and results.
Below are some comments from a few of the survey respondents…
- “MicroConstants has been a preferred provider of bioanalytical services for us for several years. Their level of technical expertise, commitment to our needs and requirements, and pricing for projects are some of the key reasons we enjoy our relationship with MicroConstants.”
- “MicroConstants’ representatives are always available to discuss your projects in depth and offer unique ways to help in solving your issues. Plus protocols, results and reports always arrive clean, making review times a breeze. It’s clear that they take their partnerships seriously.”
- “We are happy with MicroConstants high quality bioanalytical services, reasonable prices, and easy to reach location.”
We are extremely pleased with these results and will continue to do everything we can to consistently meet our customers’ needs and exceed their expectations.
AAPS Annual Meeting & Exposition
In October, our lead Pharmacokineticist, Ahmed Kousba, M.D., Ph.D., presented three posters on toxicokinetics at the AAPS Annual Meeting. PDFs of these posters are available on our website using the links below:
- Toxicokinetics of ETI-385 and its Components ETI-382 and ETI-383-A Serotonin 5 HT1A Receptor Agonist for Potential Treatment of Nausea and Vomiting, following Subcutaneous Injection of ETI-385 to CD-1 Mice and Beagle Dogs (PDF)
- Toxicokinetics of CBX129801-A Bio-active C-peptide for Potential Replacement Therapy in Type 1 Diabetic Peripheral Neuropathy, following Subcutaneous Injection of CBX129801 in Rats in a 6 Month Study with a 7-week Recovery Period (PDF)
- Toxicokinetics of CBX129801-A Bio-active C-peptide for Potential Replacement Therapy in Type 1 Diabetic Peripheral Neuropathy, following Subcutaneous Injection of CBX129801 in Monkeys in a 9 Month Study with a 7-week Recovery Period (PDF)
North American Regional ISSX Meeting
Our Director of DMPK, David Johnson, Ph.D., presented a poster at the North American Regional ISSX Meeting in October. View a PDF of the poster on our website using the link below:
- Use of Cold Compounds and High Resolution Mass Spectrometry to Quickly Characterize Drug Uptake in Cryopreserved Human Hepatocytes (PDF)
Bioanalysis (GLP and non-GLP)
MicroConstants is one of the largest bioanalytical LC/MS/MS service providers on the West Coast of the United States, housing 15 LC/MS/MS systems and occupying 34,000 square feet of office and laboratory space in San Diego, California.
Our Bioanalytical Chemistry Department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using LC/MS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and fluorescence detection. We have experience analyzing API and metabolites in more than 25 different biological matrices and can provide bioanalytical support throughout all the stages of drug development.