BianoGMP GmbH
Dr. Tobias Pöhlmann
Ronneburger Straße 74
07546 Gera

Phone: +49 365 77347180


Even if oligonucleotides are equal regarding their general structure, the specific sequence, modifications, length and other structural properties make each oligonucleotide project to a unique analytical experience. During the last years the Biano staff developed and tuned many sequence- and structure specific analytical methods and found solutions for specific customer- and oligonucleotide related requests.

During the drug development process, the analytical development can be done stepwise depending on the stage of development. Based on a risk-based approach of the manufacturing process, standards and side products/impurities can be synthesized, analytical methods can be optimized and validated. Beside drug substance analytics, there is also special knowledge in drug product analytics.

In general the scope of analytics includes:

·       Appearance

·       Identity by UPLC / HPLC (IP, RP, IEX and SEC)

·       Purity by UPLC / HPLC (IP, RP, IEX and SEC)

·       Identity by Mass Spectrometry (ESI-MS, MALDI-TOF-MS)

·       Impurity profiling by LC-MS

·       Sequencing

·       Heavy metals

·       Bioburden

·       Endotoxin

·       Structural characterization (e.g. NMR)

·       UV Spectrum

·       Melting Point

·       Extinction coefficient

·       pH

·       Conductivity

·       Salt content

·       Water content

·       Residual Solvents

Stability studies

Another aspect of analytical services comprise stability analyses. To some aspects, such as radiation, temperature, water- and salt content as well as pH, oligonucleotides show a special sensitivity. Since stability of oligonucleotide is one of the key aspects of drug safety as well as efficacy, Biano supports customers in design and offers long-term storage in controlled environments and implementation of stability studies. Also controlled degradation studies are available.


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Lab in Gera

BianoGMP GmbH
Ronneburger Straße 74
07546 Gera | Germany

Phone: +49 365 77347180
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