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.
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
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.
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.
Dr. Matteo Pennestri
Product Manager, Pharmaceutical Business Unit, Bruker
Dr. Anna Codina
Director Pharmaceutical Business Unit, Bruker BioSpin