Accelero Bioanalytics provides a comprehensive test method portfolio. From early-stage project setup (target identification, cloning, cell culture ... etc. ) up to in vivo drug product characterization (toxicokinetic profiling, pharmacodynamics, blood cell characterization ... etc. ) - Accelero covers nearly all stages of the typical drug substance / drug product development.
ELISA & Hybridization
Assay setup and validation, PK/PD bioanalysis for GLP and GCP (GCLP) studies
Real Time qPCR & RTqPCR
Fluorescence-based PK/PD assay development and validation for GLP and GCP (GCLP) studies
Flow Cytometry (FACS)
Bacterial or mammalian cell isolation, culture, characterization - multiplex assay setup and validation for GLP and GCP (GCLP) studies
RNA and Protein biomarker identification utilizing microarray glass slide technology - binding partner identfication
Pharmacokinetic / Toxicokinetic / Statistical Analysis
Data analysis for PK profiling e.g. for different routes of administration, GCP Phase 1 dose escalation studies
Supply Chain: Sample Collection / Clinical Kits and GxP Shipment Organisation
We provide clinical kits and organize the complete sample collection and shipment for your GxP studies.
Last update of this site: 20-OCT-2016 by Christian Lange
Accelerō® Bioanalytics is a leading international contract research organization (CRO) specializing in bioanalytical support assays for new nucleic acid drug development. Accelerō® Bioanalytics works closely with your firm to save you the time and expense of conducting sandwich hybridization and Real-Time RT-qPCR assays that are critical to furthering the development of your nascent siRNA/microRNA (miRNA) therapies into the clinic.
Accelerō® Bioanalytics also has a strong expertise in bioanalytical DMPK support of your monoclonal antibody/peptide hormone therapies by applying immunology assays and innovative real-time immunoassays.
As a CRO that is Good Laboratory Practice (GLP) compliant, Accelerō® Bioanalytics assures you of reliable, reproducible results from every assay, every time. Accelerō® Bioanalytics has invested the necessary resources to establish and maintain a unique GLP-compliant laboratory environment so that your company can focus on moving your nucleic acid or monoclonal antibody therapies towards FDA approval sooner and without the expense of maintaining up your own in-house, GLP-compliant lab.
When you reach the point in the development of a new nucleic acid drug when further progress requires quantitative hybridization assays to support DMPK modeling and determine dosage ranges, turn the hybridization assays over to Accelerō® Bioanalytics, your CRO of choice for all of your assay requirements.
With more than ten years of experience as a bioanalytical assay development and validation research team, Accelerō® Bioanalytics is well-equipped to carry out any type of hybridization assays needed to further your drug development process. Our expertise means that your sandwich ligand binding hybridization assays will infallibly deliver accurate quantification data that reveals how effectively your proposed therapy performs under laboratory conditions.
With a multimode microplate reader supporting all formats up to 384well plates, our clients can count on receiving infallibly dependable, reproducible and verifiable results from hybridization assays in record time. Because the time frame for developing critical new nucleic acid drugs is inevitably tight, trust Accelerō® Bioanalytics’ cutting edge, high-tech equipment and the expertise of our staff to perform hybridization assays that speed your project on its way faster than ever before.
When your drug development process requires a hyper-sensitive immunoassay format for detecting and quantifying siRNA or microRNA (miRNA) therapeutics, Accelerō® Bioanalytics stands ready to carry out the required Real-Time RT-qPCR -- reverse transcriptase-polymerase chain reaction -- assay.
Real-Time RT-qPCR is a two-step assay in which a camera monitor or other detection device quantifies the DNA amplification in progress (in real time) with the help of fluorescent probes, or DNA intercalating dyes. During Real-Time RT-qPCR, a polymerase enzyme activates the chain reaction that synthesizes complementary base sequences to each separated, single-strand DNA molecule. Precise temperature and timing intervals are critical to the accuracy of the Real-Time RT-qPCR.
Real-Time RT-qPCR can also be performed in an single tube, one-step reaction by introducing molecular biology enzymes capable of both the reverse transcription and polymerase chain reaction.
Whether you require quantitative analysis of therapeutic peptides and antibodies or another targeted analyte present in biological samples, immunology assays carried out in Accelerō® Bioanalytics’ Good Laboratory Practice (GLP) environment deliver precise data that will speed your therapy toward FDA approval.
Immunology assays depend on the predilection of particular antibodies to bind to antigens in groups of limited numbers of molecules. Peptide and antibody therapies are only effective if these therapeutics are successful in binding to target molecules, and thus, immunology assays are the most effective way to assess and quantify the occurrence of this phenomenon.
Immunology assays can detect analytes in concentrations too low for less sensitive testing to identify, such as hormones and proteins indicative of tumorous growth. Immunology assays can identify markers that point to heart injury in human patients and can detect antibodies that the body produces when such diseases as viral hepatitis, HIV, or Lyme disease are in their preliminary stages. When developing drugs that effectively combat life-threatening diseases, immunology assays are a critical component of the process, and pharmaceutical firms can get the most reliable data from a CRO with the expertise and equipment to carry out immunological assays with impeccable precision.
Accelerō® Bioanalytics is well-equipped with the experienced technical staff, the GLP-compliant facilities, and the latest assay technology to help you move your therapies from the drawing board to the marketplace more quickly and with more accuracy than ever before.
The effective completion of real-time immunoassays depends on skilled technicians, a GLP laboratory environment, and the very best equipment and software available. Because real-time immunoassays require quantification as the amplification is occurring, the CRO must be equipped with the tools and protocols that facilitate accuracy and precision of real-time immunoassays within a time-limited window.
Real-time immunoassays, such as the immuno qPCR or the proximity ligation assay, are considerably more sensitive than more commonly used formats such as the enzyme-linked immunosorbent assay (ELISA). This sensitivity of real-time immunoassays in detecting ultra-low concentrations of such substances as peptides, monoclonal antibodies and other proteins makes them the test of choice for such applications as athlete blood screening to identify any illegal substances prior to athletic competitions.
Accelero® Bioanalytics - Your Bioanalytical DMPK Assay Development & Validation Partner
Accelerō® Bioanalytics is a GLP-compliant bioanalytical CRO with the right equipment and the experienced team to deliver the accurate, reproducible data to optimize your firm’s development of critical nucleic acid drug therapies. For more than a decade, Accelerō® Bioanalytics has been providing fast, accurate data and interpretive results to clients in need of hybridization assays, Real-Time RT-qPCR, immunology assays, and Real-Time immunoassays. Now, Accelerō® Bioanalytics is positioned to keep step with the ever-accelerating pace of the nucleic acid or antibody drug development industry.