Accelerō® Bioanalytics - Good Laboratory Practice (GLP) Compliant

 

MicroRNA - The Therapeutics of Tomorrow

Welcome to the world of Accelerō® Bioanalytics. For more than ten years, we have provided Good Laboratory Practice (GLP) compliant bioanalytical services with a wide range of applications, including microRNA (miRNA) therapeutics based on recent advances in nucleic acid chemistry.

MicroRNA Therapeutics.

The breakthrough discovery of small interfering ribonucleic acid – siRNA – in the late 1990s led to an exciting new field of biotechnology based on non-specific, in vivo microRNA (miRNA) therapeutics, still in the investigative stage, for the treatment of endemic diseases such as cancer and diabetes. MicroRNA (miRNA) is the hub of a new class of therapeutics, still in the investigative stage, based on nucleic acid chemistry. Ride the wave of innovation as a worldwide swell of top R&D institutes and biotech firms navigate the uncharted waters of the microRNA (miRNA) biosphere.

MicroRNA (miRNA)is one of the latest discoveries in the investigational new drug -- IND -- arena, a logical advancement from target-specific siRNA. Unlike siRNA, microRNA (miRNA) can take on up to 100 target genes simultaneously, offering a significantly more effective result. The proliferation of targets also makes it much easier for clinicians to develop surrogate markers for microRNA (miRNA) efficacy monitoring in human clinical trials, because the chances of a measurable therapeutic effect are multiplied by 100.

However, as with any investigative therapy, microRNA (miRNA) does present preclinical and clinical drug development challenges, microRNA (miRNA) intracellular delivery topping the list. A second difficulty in microRNA (miRNA) drug development is evaluating the efficacy in human clinical trials. The creation of surrogate markers to monitor microRNA (miRNA) efficacy can provide some indications of the drug's effects, and the RACE technique in evaluating tissue samples can be effective, as well.

Services.

Accelerō® Bioanalytics provides microRNA (miRNA) assay services ranging from hybridization assays to Real-Time RT-qPCR. We also perform immunology assays to investigate immune response to microRNA (miRNA) and other nucleic acids therapeutics. Accelerō has built a reputation for excellence, with all of our work in full compliance with Good Laboratory Practice (GLP).

Accurate, Unbiased Results.

Accelerō® Bioanalytics does not manufacture or market the assay kits or supporting materials used in our microRNA (miRNA) analyses at the moment, so our clients can depend upon unbiased, accurate results. We focus on selecting the best methods to suit each individual client's specific program, whether that involves the development of microRNA (miRNA)-based therapeutics or the development of other drugs, within the parameters of Good Laboratory Practice (GLP).

We do the bioanalytical groundwork to accelerate your development of specific microRNA (miRNA) therapeutic applications, saving your organization not only money but precious time in developing critical new pharmaceuticals. Our reliable accuracy results from our Good Laboratory Practice (GLP) compliance.

MicroRNA (miRNA) and Other Assay Specialties.

From microRNA (miRNA) to siRNA, our solid phase hybridization assays accelerate the development of novel therapeutic applications. We perform Liquid phase Real-Time RT-qPCR hybridization assays for pharmacokinetics of RNA or DNA therapies, including microRNA (miRNA), of any type. Our immunology assays support pharmacodynamics in antibiotics research. To see complete details regarding our fully-GLP-(Good Laboratory Practices)compliant complement of bioanalytical assay services, including the latest in microRNA (miRNA) therapeutics, click here.

The Accelerō® Advantage.

What distinguishes Accelerō® Bioanalytics from other microRNA (miRNA) therapeutics service providers is not only our flawless record of Good Laboratory Practice (GLP) compliance, but our tenacity in following each microRNA (miRNA) project from outset to conclusion, including data management and final analysis, based on each client's preferred software or methodology.

Experience the Accelerō® Advantage today!

FDA and Good Laboratory Practice (GLP) Compliance Accelerō® Bioanalytics conducts all microRNA (miRNA) solid phase and liquid phase hybridization assays in accordance with the FDA's Guidance for Industry: Bioanalytic Method Validation. Our Good Laboratory Practice (GLP) environment is provided by a partner firm.

To learn more about how Accelerō® Bioanalytics can accelerate your microRNA (miRNA) and other therapeutics development projects in our Good Laboratory Practice (GLP) certified facilities, please explore our website. You are welcome to contact us at any time with questions or to arrange a consultation.

 

Accelerō® Bioanalytics - Good Laboratory Practice (GLP) Compliant.

 

Background.

In the 1990s, medical researchers laid the foundation for microRNA (miRNA) nucleic acids therapeutics with their discovery of the ability of small single strands of non-coding RNA or DNA aptamers to bind to target molecules. Late in the same decade, David Baulcombe led a group of British researches in the discovery of small interfering RNA, or siRNA, that alters the expression of a specific gene, as well as acting as an antiviral mechanism in RNAi-related paths.

In 2002, the work of Nobel laureates Sydney Brenner, H. Robert Horvitz, and John E. Sulston investigating "the genetic regulation of organ development and programmed cell death" facilitated the discovery of the RNA interference (RNAi) mechanism, with two primary molecule types -- microRNA (miRNA) and small interfering RNA (siRNA). Their work inspired new, targeted research into directing these molecules to bind with messenger-type, protein encoding RNA molecules to naturally regulate gene expression (1).

Different types of microRNA (miRNA) or siRNA molecules, when properly targeted, can defend a cell against viruses and other parasitic genes that cause cancer, metabolic disease, and cardiovascular disease. For example, when tumor-suppressive microRNAs (miRNA) no longer function in cancer patients, microRNA (miRNA) therapy can introduce new microRNAs (miRNA) into the diseased tissues that will take up the fight, reactivating systemic microRNA (miRNA) pathways that interfere with tumor production and block proliferation of the diseased cells. This represents only one of the multitude of ways in which new microRNA (miRNA) therapies are revolutionizing medicine.

MicroRNA (miRNA) medical breakthroughs have launched a maelstrom of nucleic acids therapeutics research that is creating an entirely new class of microRNA -(miRNA) based pharmaceuticals, with much of the research still in the developmental stages. The importance of bioanalytical services that are fully compliant with Good Laboratory Practice (GLP) guidelines cannot be understated in accelerating the development of critical microRNA (miRNA) therapies.

Accelerō® Bioanalytics recognizes the critical role our services play in accelerating the development of microRNA (miRNA) and other nucleic acid-based therapies that could positively affect large segments of the world's population. We do not take that responsibility lightly. Our services come with the FDA's Good Laboratory Practice (GLP) certification, plus a wealth of experience producing reliable, accurate, and reproducible results.

MicroRNA (miRNA) Research.

Scientists have identified several hundred human microRNA (miRNA) during the last decade. As of March 2011, the MIR2Disease microRNA (miRNA) database documented more than 1900 research-verified links between 299 types of microRNA (miRNA) and 94 human diseases. Researchers speculate that each microRNA (miRNA) molecule has the ability to regulate dozens of genes, with an individual microRNA (miRNA) acting as one circuit in a breaker box that controls entire groups of genes in a metabolic chain, including those facilitating such processes as cell growth and differentiation, and embryo growth (2).

MicroRNA (miRNA) Knowledge.

Nucleic acid therapeutics studies have identified links between several microRNAs (miRNA) and specific forms of cancer. Ongoing research aims to pinpoint new therapeutic connections between microRNA (miRNA) and disease, with the ultimate goal of developing microRNA (miRNA) - based drugs for a multitude of applications.

Accelerō® Bioanalytics Can Help.

Accelerō® Bioanalytics is a contract research organization offering microRNA (miRNA) assay services that are fully compliant with Good Laboratory Practices (GLP), expressly designed to support preclinical bioanalysis of critical new microRNA (miRNA) therapies. We manage the microRNA (miRNA) data throughout the process, as well as perform final analysis of results, in order to provide our clients with the most reliable, Good Laboratory Practice (GLP) compliant bioanalytic services available, industry-wide. For further information into how we can accelerate your microRNA (miRNA) drug development, contact us today. Experience the Accelerō® advantage!

References:
1. http://nobelprize.org/nobel_prizes/medicine/laureates/2002/press.html
2. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2686559/

 

Accelerō® Bioanalytics - Good Laboratory Practice (GLP) Compliant.

 

Types of MicroRNA (miRNA) Quantitative Assays.

During the development of any new microRNA (miRNA) or nucleic acid drug, ligand binding assays performed under Good Laboratory Practice (GLP) guidelines provide critical data to support PK/PD modeling in studies to determine dosage ranges for a particular microRNA (miRNA) therapy. Capillary gel electrophoresis (CGE) or liquid chromatography/mass spectrometry LC/MS may provide sufficient data for microRNA (miRNA) systemic dosage determination, but these methods of analysis may not produce the optimal level of precision.

Without adequately quantified results, the microRNA (miRNA) research team may need to re-extract the analyte from biological samples, at a prohibitive expense. Alternatively, microRNA (miRNA) drug development firms utilizing results from CGE or LC/MS/MS assays may compensate for imprecision by downsizing the dosage of the microRNA (miRNA) therapeutic drug. They may further endorse local rather than systemic microRNA (miRNA) drug delivery with the intent to minimize systemic exposure, to ensure a "No Observed Adverse Effect Level" result.

Accelerō® Bioanalytics Hybridization Assays.

The sandwich hybridization assay -- also called a dual probe, or capture assay -- is one of the most commonly-utilized ligand binding assays in nucleic acid therapeutics drug development, especially for siRNA and microRNA (miRNA) drugs. Performance of these assays in a Good Laboratory Practice (GLP) compliant environment is of utmost importance in obtaining accurate, reliable, reproducible results.

Many leading biotechnology firms developing microRNA (miRNA) drugs rely on the results of ligand binding assays, and sandwich hybridization assays in particular, to support microRNA (miRNA) pharmacokinetic characterization, primarily due to the following advantages:

• Applicable to virtually any biological sample

• Endorsed by legal authorities throughout the world

• Applicable to pharmacokinetics on aptamers, CpG oligos, ribozymes, siRNA, microRNA (miRNA), antisense, and many more

• Excellent limit of detection, in combination with outstanding selectivity for microRNA (miRNA) and siRNA drugs

• Superior accuracy and precision

• Eliminates the need for maintaining expensive lab equipment such as LC-MS/MS devices

The only potential disadvantage to sandwich hybridization assays is the shortage of excellent, experienced, Good Laboratory Practices (GLP) compliant contract research institutes that perform ligand binding assays for microRNA (miRNA) drug development with reliable precision.

Accelerō® Bioanalytics is the Solution.

Accelerō® Bioanalytics provides the optimized precision of hybridization-based, solid phase microplate assays, delivering an excellent limit of detection at a lower limit of quantification. Accelerō® assays extract the data so critical to dosage determination for newly-developed microRNA (miRNA) therapeutics, facilitating the furtherance of the development process in a cost-effective, time-conserving, and quintessentially professional manner.

Our Good Laboratory Practice (GLP) compliant facilities mean that our assay results are dependably accurate and reliable. Our comprehensive microRNA (miRNA) bioanalytical services provide sandwich hybridization ligand binding assays of any kind, including:

• Hybridization ligand binding assays for aptamers (1)

• Hybridization ligand binding assays for CpG oligonucleotides (2)

• Hybridization ligand binding assays for antisense therapeutics (3)

• Hybridization-ligation assays (4)

• Competitive hybridization ligand binding assays for antisense therapeutics (5)

• Ligation assay/qPCR combinations to detect viral point mutations (6)

• Branched DNA probe ligand binding assays for transcript quantification (7)

• And many more

Experienced Accelerō® Bioanalytics professionals complete customized microRNA (miRNA) hybridization-based, solid phase microplate assays in a Good Laboratory Practice (GLP) compliant environment to ensure that each client receives the most accurate results possible.

References:
1. Drolet DW et al, Pharm Res 2000, Sept;17(12): 1503-10
2. Efler SM et al, Oligonucleotides 2005 May;15: 119-31
3. Dai G et al, Clin Cancer Res 2005 April;11(8): 2998-3008
4. Yu RZ et al, Anal Biochem 2002 April;304: 19-25
5. Deverre JR et al, Nucleic Acids Res 1997, July;25(18): 3584-9
6. Edelstein RE et al, J Clin Microbiol 1998, Nov;36(2): 569-72
7. Canales RD et al, Nature Biotech 2006 Sept;24(9): 1115-22

 

Accelerō® Bioanalytics - Good Laboratory Practice (GLP) Compliant.

 

Pharmacokinetics and Statistics

Pharmacokinetics -- the way in which the body interacts with a drug -- provides useful data in the early stages of microRNA (miRNA) drug development. By measuring how a microRNA (miRNA) drug affects target molecules or adversely affects the body, and for what period of time, developers can determine optimum dosages of the microRNA (miRNA) drug in development. Further study into the effects of repeat dosages helps developers fine-tune microRNA (miRNA) therapies for ultimate efficacy.

Our senior scientists at Accelerō® Bioanalytics exclusively oversee each phase of your microRNA (miRNA) therapeutics assay validation and analysis program to ensure superior results in compliance with Good Laboratory Practice (GLP). Accelerō® Bioanalytics provides comprehensive full service to each and every client. We work one-on-one with you to ensure your organization's unique requirements are adequately addressed every step of the way. Our senior scientists preside over each aspect of our comprehensive microRNA (miRNA) bioanalytics services, including:

• Ligand binding assay selection from the portfolio

• Ligand binding assay setup and development

• ligand binding assay validation for the matrix of choice

• ligand binding assay of biological samples from preclinical studies

• PK/PD data analysis

Our senior scientists direct complete pharmacokinetic analysis of your microRNA (miRNA) data, using the latest technological tools available, such as WinNonlin software support. We explore statistical significance using the technology of various software platforms. Our facilities are Good Laboratory Practice (GLP) compliant. Contact Accelerō Bioanalytics today to accelerate your microRNA (miRNA) drug development.

Experience the Accelerō® advantage! All services are fully compliant to Good Laboratory Practice (GLP) regulations (21 CFR part 53).

History.

Good Laboratory Practice (GLP) in the microRNA (miRNA) therapeutics research arena involves a system of quality controls that ensure consistently reliable, reproducible results. First established by the FDA (U.S. Food and Drug Administration), Good Laboratory Practice (GLP) has been adopted by other agencies as well, including EPA, which have incorporated Good Laboratory Practice (GLP) into their own regulatory literature.

FDA originally instituted GLP (Good Laboratory Practice) in response to fraudulent pharmaceutical and industrial manufacturing testing. Good Laboratory Practice (GLP) delineated standards that ensured the integrity and reliability of safety-related test results.

Good Laboratory Practice (GLP), as applied to the non-clinical microRNA (miRNA) research setting, outlines the principles of a platform upon which laboratory research should be planned, carried out, and reported. Good Laboratory Practice (GLP) provides guidelines for the monitoring, recording and archiving of laboratory research.

Good Laboratory Practices (GLP) Compliance.

At Accelerō® Bioanalytics, our work generates the critical data our clients need to assess the efficacy of microRNA (miRNA) and other drugs in development. Our microRNA (miRNA) analysis, executed in strict compliance with Good Laboratory Practice (GLP), aims to identify any human hazards and risks inherent in nascent microRNA (miRNA) therapies at the preclinical stage, and provide reliable data that reflect true, reproducible microRNA (miRNA) therapeutics results. Regulatory authorities depend on the accuracy of our assays when determining the safety of a newly-emerged microRNA (miRNA) therapy.

Our Pledge to You.

Accelerō® Bioanalytics guarantees full compliance with FDA Good Laboratory Practice (GLP) regulations, providing comprehensive microRNA (miRNA) drug development support for our clientele from the beginning of the process to the conclusion. We develop and validate both our solid phase and liquid phase microRNA (miRNA) assays in accordance with current FDA guidelines (1). We actively update our ligand binding assay Good Laboratory Practices (GLP) in accordance with the latest FDA guideline revisions.

Good Laboratory Practice (GLP) Partnerships.

Accelerō® Bioanalytics is aspired to become an active member since 2010 of a global alliance to standardize the field of microRNA (miRNA) and other drug bioanalysis among contract research organizations and the pharmaceutical industry (2, 3). As a member of this alliance, we have the ability to provide state-of-the-art microRNA (miRNA) assay validation to our valued customers. Accelerō® Bioanalytics relies on our friendly partner AZ Biopharm GmbH, Berlin, Germany, to provide our Good Laboratory Practice (GLP) environment.

References:
1. FDA Guidance for Industry: Bioanalytical Method Validation. May 2001
2. Premkumar N et al, Bioanalysis 2010 Nov;2(11): 1797-1800
3. van Amsterdam P et al, Bioanalysis 2010 Nov;2(11): 1801-3

 

Accelerō® is a registered trademark of Accelero Bioanalytics, Berlin.

More details on microRNA (miRNA) bioanalytics in drug development are kindly presented in our microRNA blog.