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Time Domain Nuclear Magnetic Resonance

New Benchtop TD-NMR Solutions for Pharma and BioPharma

This webinar took place on January 26, 2021

Bruker introduces ‘over the counter’ solutions for different pharmaceutical unmet needs such as phase purity, including quantification of low levels of amorphous, 100% fill check of vials and syringes and aggregation determination.

Overview

The minispec Form Check is reliable and affordable TD-NMR (Time-Domain Nuclear Magnetic Resonance) solution to monitor phase purity and quantify physical API forms with an LOQ as low as 1% even when quantifying amorphous forms. The minispec Form Check uses 1H relaxometry data as easy-to-obtain fingerprints for expected components in solid mixtures, replacing excessive calibration, delicate sample preparation and expert know-how. The new minispec Form Check combines the reliable minispec mq20 benchtop spectrometer with the well-established IconNMR interface for simple experiments submission and the newly developed Mestrelab software for Polymorphism/Amorphous automatic data analysis. The workflow is 21 CFR part 11 compliant to ensure data integrity and comes with a GxP readiness kit that includes instrument qualification and computer systems validation.

The established One Step Contactless Check Weighing is now back to the spotlight with the rise of bio-therapeutics and potent drugs. High accuracy, 100% fill check of vials and syringes is now possible in a matter of seconds. The method is non-invasive, preserving the sterility of the samples, and it comes in an affordable benchtop format! The results from a study performed in collaboration with one of the major pharmaceutical companies will be presented, showing the accuracy of non-destructive measurements directly in its own sealed container.

Finally, the use of TD-NMR to measure protein aggregates will be discussed. Protein therapeutics have a propensity for aggregation during manufacturing, shipping, and storage. This is of concern to both manufactures and regulatory agencies because it can induce adverse immune responses in patients that may affect safety and efficacy. The challenge in analysing protein aggregates lies in the unknown nature of the formed aggregates as well as its wide size range. It is often necessary the use of a combination of techniques. Most of these techniques require opening the vial to test the content, an undesirable feature when analysing sterile finished products (vials or filled syringes). Assessment at the point-of-care is mostly done by visual inspection with a large associated error. We offer a simple, effective and affordable method to analyse protein aggregates with a benchtop TD-NMR spectrometer, based on the measurement of T2 relaxation of water.

TUESDAY, January 26, 2021
07:00PM AEST | 09:00AM CET

What to expect

After a short outline to TD-NMR, the webinar will focus on the ease of use of the minispec Form Check method, illustrating how to quantify solid forms and giving details about the latest GxP Readiness Kit for minispec.

The unique features of Contactless Check Weighing (e.g. sealed container as vials and syringes) with real case examples from the Pharmaceutical Industry will be described. Moreover, an effective and affordable method to analyse protein aggregates with a benchtop TD-NMR spectrometer, based on the T2 measurement relaxation of water will be described.

Key Points

  • An Overview of TD-NMR Solutions
  • Solid Form Quantification
  • Contactless Check Weighing
  • Protein Aggregates Analysis

Who should attend?

The webinar is aimed for those working in the pharmaceutical industry, especially in drug development and production of pharmaceuticals and biopharmaceuticals. Laboratory managers, heads of R&D, analytical development, quality control and manufacturing.

Additionally, the webinar is also of interest to those academics collaborating with pharmaceutical industry and to other industries who face challenges in formulating both solid and liquid mixtures.

Speakers

Dr. Matteo Pennestri

Product Manager, Pharmaceutical Business Unit, Bruker

Matteo Pennestri obtained his Ph.D. in Biophysical methods at the University of Tor Vergata Rome (collaboration with Merck Sharp and Dohme). Then he moved as NMR spectroscopist in the pharmaceutical industry (MSD and EISAI). After experiencing the pharma sector, he joined as application scientist Agilent Technologies first (ex. Varian) and Bruker afterwards. Recently he joined the Bruker Pharma unit as NMR specialist and product manager.

Dr. Anna Codina

Director Pharmaceutical Business Unit, Bruker BioSpin

Anna has a degree in Chemistry and a PhD in Protein NMR from the University of Barcelona, Spain. During this time she did several industrial placements at pharmaceutical industries (Pharmhispania, Spain, and Genentech, SF, USA) and she worked for the NMR service of the University. She then moved to Cambridge, UK, to do a post-doc in protein NMR at the MRC Laboratory of Molecular Biology.

After her post-doc she worked in the Analytical R&D department of Pfizer, UK, for 8 years, becoming proficient in low level impurity structure elucidation, reaction monitoring, qNMR and the preparation of regulatory documentation.

She joined Bruker in 2011 as Material Characterisation Laboratory Manager. Since then her role has evolved. She started looking after the pharmaceutical market in 2015 as Product Portfolio Manager. Anna and team launched several products: InsightMR, InsightXpress and InsighCell for process understanding and monitoring; Fragment Based Screening analysis tools, PotencyMR for potency determination of drugs by qNMR; the minispec Form Check for solid form quantification and NMR Instrument Qualification packages to facilitate compliance. She is now director of the pharmaceutical business Unit at Bruker BioSpin.