Cerbios-Pharma introduces new NMR capability for HPAPI analysis and kinetic studies

Lugano, Switzerland: – Pharmaceutical ingredient specialist Cerbios-Pharma SA (Cerbios) has significantly expanded its already outstanding analytical chemistry capabilities with the commissioning of a new state-of-the art Nuclear Magnetic Resonance (NMR) spectrometer.

The Jeol YH 400 now installed at the Cerbios’ Lugano facility is a 400 MHz NMR that complements the HR-Q-TOF mass spectrometer, Differential scanning calorimetry (DSC), Ultra-performance liquid chromatography (UPLC) and other analytical chemistry equipment.

The installation became operational from April 1.

HPAPI Characterization

The new instrument is equipped with a multi-nucleus probe and autosampler, thus allowing completely automated acquisition of mono- and bi-dimensional NMR spectra. With these new capabilities, Cerbios researchers will be able to perform complete characterization of highly potent active pharmaceutical ingredients (HPAPIs), identification of impurities, and carry out critical kinetic studies in house.

Streamlined R&D

“This is a major step in streamlining our R&D activities,” commented Cerbios R&D Director Alberto Terraneo.

“We have also created an NMR team, which will improve the analytical department’s response time and self-sufficiency. The NMR team will perform and interpret the more complex spectrometry experiments to support the needs of our R&D and QC departments,” said Mr. Terraneo.

About Cerbios-Pharma

Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacturing of both chemical and biological APIs for its partners world-wide.

Exclusive CDMO services are offered for the development and manufacturing of high potency active ingredients (HPAIs) as well as for biological products including monoclonal antibodies, recombinant proteins and antibody drug conjugates (ADCs).

Cerbios provides full CMC support, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs, with paramount ability to support a successful registration. Cerbios is a worldwide presence with partners in Europe, USA and Japan.

Cerbios, along with AGC Biologics and Oncotec, is a member of PROVEO™, an integrated ADC manufacturing solution.

PROVEO can offer a ADCs end-to-end service from drug substance development till sterile fill & finish.