Accelero Bioanalytics

Schulzestrasse 20
Berlin, 13187
Germany

Phone: ++49 30 43 73 77 48
Fax: ++49 30 48 47 63 28
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Description:

Welcome to Accelerō Bioanalytics

Accelerō Bioanalytics is a preferred partner in bioanalytical services for the nucleic acids biotechnology and pharmaceutical industry. Accelerō Bioanalytics is located right in the heart of Germany. Participate in an environment that is unique in Europe, research and development is taking place at five universities, three universities of applied sciences and more than 20 research institutes.

Benefit from Our 10 Years Aniversary

Don´t waste time to develop your bioanalytical methods which we already might provide. Experience the advantages. In 2010 we have been dealing with quantitative bioanalytics for more than 10 years. Our services range from hybridisation assays to Real-Time qPCR to detect your investigational new drug based on nucleic acids chemistry (RNA/DNA). We also offer immunology assays to investigate immune response to nucleic acids therapeutics. Certainly all of these are fully compliant to GLP regulations.

GLP Compliant Sandwich Hybridisation Portfolio

Solid phase hybridisation-based microplate assays have been uncovered to combine an excellent limit of detection (LOD) with outstanding assay performance at lower limit of quantification (LLOQ). Accelerō Bioanalytics comprehensive service portfolio provides sandwich hybridisation assays of any kind: hybridisation assays for aptamers, CpG oligonucleotides, or antisense therapeutics, hybridisation-ligation assays, competitive hybridisation assays for antisense therapeutics, ligation assay/qPCR combinations to detect viral point mutations, branched DNA probe assays for transcript quantification, and many more. Simply select from our assay portfolio.

GLP Compliant Real-Time-RT-qPCR

Accelerō Bioanalytics is now proud to be one of the first to provide Real-Time RT-qPCR services fully compliant to Good Laboratory Practice (GLP) regulations. We provide custom-made Real-Time RT-qPCR e.g. for both mRNA and micro RNA quantification, or for single nucleotide polymorphism (SNP) genotyping.

Another recently developed application of Real-Time qPCR uncovers an appealing area of increasing interest: the quantification of nucleic acid therapeutics in preclinical development. Hot off the press publications demonstrate the ability to quantify short interfering RNA (siRNA) drugs in biological samples even at the sub-femtomolar range. This is particularly important if the systemic exposure to your RNA drug is expected to be quite low. If applied to plasma samples for pharmacokinetics (PK), the Real-Time RT-qPCR limit of detection (LOD) can be approx. 20fold more sensitive than for conventional sandwich hybridisation assays.

Accelerō Bioanalytics offers custom-made quantitative Real-Time RT-qPCR assays for your investigational new nucleic acid drug like siRNA, micro RNA, or RNA aptamers. Such nucleic acid drugs can also comprise RNA transcripts or DNA plasmids for immune system modulation. The MIQE guidelines are obligatory.

GLP Compliant Immunology Assays

The typical drug development cycle of novel biotherapeutics as well as nucleic acid drugs comprises not only the PK behaviour among the species, but also PD aspects like complement activation or any other immunogenicity triggering. Especially if you apply liposome vehicles to shuttle your siRNA drug into the cells, you may reckon with immune response either to the liposome or the drug itself, or both.

Accelerō Bioanalytics offers nearly any kind of imunological assays which can be performed in 96well or 384well microplates. All assays are validated according to appropriate guidelines). Additional publications with regards to immunoassay validation are mandatory. Customers can choose from polyclonal and monoclonal antibody technology for sandwich assays, competitive assays, immunoprecipitation assays, or unspecific ELISAs for total immune response detection to specific antigens. Other typical applications are: inflammation response monitoring (total and subclass IgG, IgE, IgA, IgM, cytokines, etc), assays for immunogenicity detection to your nucleic acid drugs or therapeutic monoclonal antibodies), complement activation monitoring, pathogen pharmacodynamics in antibiotics research (detection by ELISA or Real-Time qPCR), biomarker quantification as surrogate markers in preclinical or clinical drug developmen. Simply select from our assay portfolio.

GLP Compliant Pharmacokinetics & Statistics

Accelerō Bioanalytics offers an all-in-one-hand service to its customers. In plain language, customer projects are supervised right from the beginning: assay selection from the portfolio, assay setup and development, assay validation for the matrix of choice, assay of biological samples from preclinical studies, and finally PK/PD analysis of the data.

Certainly we also offer comprehensive pharmacokinetic data analysis including WinNonlin software support. Statistical significance is explored using various software packages. Both services are exclusively brought to you by partnered senior scientists superior in this field.

GLP Compliance

Both solid phase and liquid phase hybridisation assays will be developed and validated in accordance to current FDA guidelines. Accelerō Bioanalytics is aware of a recently published whitepaper which indicates a guideline update in the near future. Additional publications with regards to ligand binding assay validation are mandatory.

In 2010 a global alliance was formed to harmonize bioanalysis among contract research organizations as well as pharmaceutical industries. Accelerō Bioanalytics is aspired to join the alliance to provide state-of-the-art assay validation to its customers.

We guarantee fully compliance to Good Laboratory Practice (GLP) regulations. Accelerō Bioanalytics customers will experience a comprehensive service and support from the beginning.

Last update of this entry: March 25, 2011