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Articles

Quality Control Analysis of Oligonucleotide Therapeutics: One Platform Method for Determining Identity, Purity, and Quantity

https://www.biopharminternational.com/bp_w/QC

Oligonucleotide development continues to be a growing area of interest in the pharmaceutical industry. A&M STABTEST is a CRO known for its proactive approach to customers’ projects. When challenged to develop a QC method for identification and impurity analysis of oligonucleotides, the CRO utilized new technology to respond to their sponsor’s needs.

Use of compliant-ready instrumentation and software to enable oligonucleotide analysis in a GMP environment

Evaluation of various ion-pairing reagents when developing oligonucleotide QC methods

Identification of analytical conditions that impact quality of oligonucleotide data


Pharmaceutical Industry and Contract Organization Directors, Lab Manager’s and Scientists

For any questions please contact Jorge de la Bandera: JdelaBandera@mjhlifesciences.com

Thomas Franz finished his PhD 1992 at Würzburg University (Germany) in organic chemistry. Afterwards he went for post-doctoral work to Thailand and did his research at the Chulabhorn Research Institute in Bangkok, followed by a more than 3 years proteomics research at Nagoya University, Japan. Then he became Head of Proteomic Core Facility at EMBL Heidelberg, Germany and after his tenure he went to Cologne/Germany to build-up the Bio-MS facility in the newly founded MPI for Biology of Ageing. In 2015 he joined A&M Stabtest GmbH, Bergheim, Germany as Study Director for biopharmaceutical mass spectrometry.

Webcasts

Thursday, June 23, 2022 at 10am ET | 3pm BST | 4pm CEST

Join us on June 23 to learn about QC Analysis of Oligonucleotide Therapeutics. One Platform Method for Determining Identity, Purity, and Quantity. 

  QC Analysis of Oligonucleotide Therapeutics: One Platform Method for Determining Identity, Purity, and Quantity

Medical Devices: Minimizing the Risk of Non-Compliance Through Enhanced Chemical Testing

Podcasts

Understand challenges posed by updated E&L guidance for medical devices (ISO 10990-18)
Insight into considerations for analytical setup that impact regulatory compliance
Overview of materials E&L risk profiles and testing requirements