What challenges has MPI Research faced in offering bioanalysis of small molecules and how has the company overcome these challenges?
The complexity of new chemical entities that our Sponsors are bringing forward continues to challenge our scientists’ expertise in developing and validating bioanalytical methods. We have developed novel methods for oligonucleotides, peptides, and chiral molecules from both conventional and unconventional biomatrices (e.g., ocular, toenail, and muscle). Our approach to developing these methods incorporates a structured and systematic approach using orthogonal assay designs to ensure that robust methods are available in a timely fashion. Indeed, we pride ourselves on taking on projects that other contract research organizations (CROs) may not consider.
LC-MS/MS is the standard platform for conventional small molecules, but on occasion it is not the best platform for certain classes of molecules. MPI Research has invested in GC-MS/MS and ICP-MS to ensure that multiple detection platforms are available to meet the needs of our Sponsors.
Last month, MPI Research secured a second Gyrolab xP workstation, a nanoliter-scale immunoassay platform. What major advantages has the company experienced with the installation of these workstations?
The Gyrolab™ workstation and the Gyrolab CD format have enabled MPI Research to perform immunoassays using only nanoliters of sample. The automation and unique flow-through design reduces “hands-on” time and significantly speeds up throughput. Moreover, the system offers an unprecedented four-log dynamic range thus reducing the need for repeat sample analysis with additional sample dilution. Results can be generated within one hour from a single CD or the system can be left unattended to run multiple CDs for up to five hours. Compared to conventional ELISA, the Gyros platform has shown equal or better overall performance, while exhibiting a wider analytical range and a reduction in matrix-interference effects. Methods developed to date demonstrate accuracy and precision well within acceptable limits over the dynamic ranges for a number of assays.
MPI Research has successfully applied the Gyrolab™ workstation to the development of fit-for-purpose assays for safety-predictive biomarkers, including two inflammation biomarkers, neutrophil gelatinase-associated lipocalin (NGAL), and tissue inhibitor of metalloproteinase 1 (TIMP-1). In rodent studies, NGAL and TIMP-1 were employed as safety biomarkers to assess toxicological risk.
How else will MPI Research expand its portfolio in terms of products and services over the next year?
MPI Research will continue to increase capacity for high-throughput bioanalysis through a strategic investment in automation. The goal is to sustain high levels of productivity and support our Sponsors’ demand for rapid data release. In response to demand, we will continue to expand our inventory of assays for biosimilars and predictive biomarkers. MPI Research is well positioned to produce the critical reagents for biosimilar ELISA methods. The company also is uniquely positioned to provide a center of excellence for metal analysis using ICP-MS. Demand for bioequivalence studies of therapeutic metals (e.g., potassium) has increased, and MPI Research recently expanded and renovated space for metals analysis at its State College facility. MPI Research will continue to develop and validate GC-MS/MS assays for neurotransmitters, steroids, and metabolites of Vitamin D to meet Sponsor demand for these unique assays.
How has MPI Research confronted bioanalytical regulatory initiatives?
The reliable reporting of data from the quantitative analysis of drugs and their metabolites is at the core of what the bioanalytical laboratories, at MPI Research, provide its Sponsors. MPI Research is routinely inspected by regulatory authorities and the prior two inspections of bioequivalence studies by the FDA resulted in no Form 483 observations.
The regulatory agencies of different countries each have their respective guidance documents describing the requirements for bioanalytical method validation and the application of these methods to routine drug analysis. Given this backdrop, MPI Research actively participates in the Global Bioanalysis Consortium (GBC) whose stated mission is to “merge existing or emerging bioanalytical guidances to create one, unified consensus document that can be presented to the regulatory bodies/health authorities in various countries.” MPI Research is an active member of the Global CRO Council (GCC) that regularly meets to address scientific and regulatory issues in the bioanalysis field. The GCC provides a platform for member companies to discuss day-today common issues in bioanalysis, voice opinions, generate whitepapers, and communicate with global regulatory agencies.
MPI Research will continue to stay well-informed of regulatory authority initiatives through active participation in the GBC-, GCC-, and APAsponsored workshops and industry conferences on regulated bioanalysis. Through this participation we will ensure that our standard operating procedures are updated to remain in full compliance with regulatory authority expectations.
What is the general scope of services offered by MPI Research?
From target identification and validation through lead optimization, candidate selection, preclinical development, and early clinical development, MPI Research provides innovative solutions to meet the development needs of its drug, device, and chemical Sponsors. A comprehensive array of research services is provided within three divisions that collaborate closely: Discovery Sciences (In Vitro Services, In Vivo Models, Imaging, Medical Device Evaluation, and Surgical Studies); Drug Safety and Preclinical Sciences (General Toxicology, Developmental and Reproductive Toxicology, Infusion Toxicology, Safety Pharmacology, Neurobehavioral Sciences, and Anatomic as well as Clinical Pathology); and Laboratory Sciences (Antibiotic Potency Testing, Dose Formulation Analysis and Method Development, Immunology, Bioanalytical Analysis, Environmental & Food Safety Testing, and Reference Standard Management) in meeting Sponsor needs.
What sets MPI Research apart from competitors?
MPI Research is the world’s largest single-site preclinical contract research organization with more than one million square feet, and is committed to maintain cutting-edge technology in direct response to the strong demand from our Sponsors.
MPI Research is focused on driving efficiency and scientific integrity within drug development. Through leveraging an increasing scale of resources, breadth of experience, and investment in technology, we partner with global biopharma organizations to develop new therapeutics faster and more effectively in compliance with multiple regulatory agencies and global market requirements. MPI Research provides Sponsors with drug development resources as a variable cost in place of internal fixed cost resources at significant advantage to cost, time and technology hurdles. We deliver the expertise, best-in-practice science and execution that enable our Sponsors to meet the demands of tomorrow’s medicines.
What can we expect from MPI Research at the BIO International Convention this month?
Visit MPI Research at exhibit #2757 at the 2012 BIO International Convention to learn more about our world-class scientific talent and how the company can cost-effectively meet the needs of Sponsors who are facing development delays due to recent reductions by other CROs.