Applied Biosystems Real-Time PCR System
Late last year, we purchased and qualified an Applied Biosystems Real-Time PCR System to measure relative mRNA levels for cytochrome P450 (CYP450) induction assays. Using this instrument, we can report relative induction caused by incubation of a test article with plated hepatocytes using both enzyme activity and mRNA endpoints per the FDA’s Draft Guidance for Industry for Drug Interaction Studies (view guidance). Depending on your project needs, we can perform CYP induction assays for regulatory submission or for screening. The PCR instrument can also be used to support a variety of research projects involving the quantitation of DNA and RNA, such as potency assays and mRNA quantitation.
Waters NuGenesis ELN
After months of evaluating electronic laboratory notebook (ELN) vendors, we decided to purchase the Waters NuGenesis ELN in January. The analytical chemistry electronic laboratory notebook will integrate with our existing LIMS to better streamline our laboratory processes and increase overall efficiency. It will automate the majority of our QA and QC processes, significantly reducing the time between sample analysis and reporting audited data to our clients. Once implemented, we will utilize the system to automate routine calculations, organize day-to-day work more efficiently in the laboratory, and track, assign, and manage samples, tests and results. Implementation will be complete by the end of this year.
New Case Study
Simultaneous Determination of Free and Covalently Bound Drug Concentrations
Our latest case study details how we helped advance our client’s development program by developing a novel extraction and derivatization scheme to simultaneously determine free and covalently bound drug concentrations using a single assay.
Read this case study.
MicroConstants has always been committed to providing our pharmaceutical and biotech partners with the highest quality data, exceptional client services, and solutions to their challenging scientific problems. But don’t just take our word for it… read what some of our clients had to say.
7th Workshop on Recent Issues in Bioanalysis (WRIB)
On April 9th & 10th, several MicroConstants employees will be in Long Beach, CA for the WRIB workshop focusing on the latest challenges the bioanalytical community is facing. The event will include a panel discussion session with regulators from all over the world addressing ways the bioanalytical community can interpret and implement the new FDA BMV guidance in a global context. Participating regulatory agencies include US FDA, Europe EMA, Brazil ANVISA, Heath Canada, Japan MHLW, and UK MHRA. If you plan to attend, be sure to stop by our table (#7) and say hello.
AAPS National Biotechnology Conference
MicroConstants will be exhibiting at the 2013 AAPS National Biotechnology Conference in San Diego, CA on May 20th & 21st.
In addition to an exhibit table, we will be presenting the following posters:
- Comparison of Encapsulated and Non-encapsulated Doxorubicin Pharmacokinetics Following Single Intravenous Administration of ATI-0918—An Encapsulated Liposomal Formulation, and DOXIL®
- Pharmacokinetics of Subcutaneously-administered CBX129801—A Long-acting Synthetic C Peptide in Patients with Type 1 Diabetes Mellitus
Immediately following the conference, PDFs of these posters will be available on our website at www.microconstants.com/posters.
For our clients needing bioanalytical support for large clinical studies, we have 15 LC/MS/MS systems and the following automated sample preparation technologies that allow us to analyze more samples, faster, and with better results:
- 3 Spark Holland Symbiosis on-line SPE systems capable of processing samples with little to no sample preparation by our scientists. Samples are processed during the previous injection’s chromatographic run time. Typical methods will allow automated analysis of 1,000 samples per day or more depending on how quickly the analytes can be chromatographed.
- 6 Waters ACQUITY UPLC systems capable of increasing sample throughput, reducing solvent use, and performing complex separations more quickly than traditional HPLC systems. Their sample organizers are capable of shuttling up to 22 well plates into the sample manager for analysis, increasing the level of automation and sample processing throughput. Samples processing can be streamlined through 96 well plate SPE or SLE followed by analysis by UPLC coupled with MS/MS detection. The UPLC systems are capable of unattended sample analysis for days allowing night and weekend instrument time to be utilized more effectively.
Contact us for more information on our high-throughput bioanalysis capabilities, or to request a quote.