Exploring Feature Selection and Classification Techniques to Improve the Performance of an Electroencephalography-Based Motor Imagery Brain-Computer Interface System.

The accuracy of classifying motor imagery (MI) activities is a significant challenge when using brain-computer interfaces (BCIs). BCIs allow people with motor impairments to control external devices directly with their brains using electroencephalogram (EEG) patterns that translate brain activity into control signals. Many researchers have been working to develop MI-based BCI recognition systems using various time-frequency feature extraction and classification approaches.

In depth characterization of physicochemical critical quality attributes of a clinical drug-dendrimer conjugate.

A deep and detailed understanding of drug-dendrimer conjugates key properties is needed to define the critical quality attributes that affect drug product performance. The characterization must be executed both in the formulation media and in biological matrices. This, nevertheless, is challenging on account of a very limited number of suitable, established methods for characterizing the physicochemical properties, stability, and interaction with biological environment of complex drug-dendrimer conjugates.

Considerations for the Terminal Sterilization of Oligonucleotide Drug Products.

A primary function of the parenteral drug product manufacturing process is to ensure sterility of the final product. The two most common methods for sterilizing parenteral drug products are terminal sterilization (TS), whereby the drug product is sterilized in the final container following filling and finish, and membrane sterilization, whereby the product stream is sterilized by membrane filtration and filled into presterilized containers in an aseptic processing environment. Although TS provides greater sterility assurance than membrane sterilization and aseptic processing, not all drug products are amenable to TS processes, which typically involve heat treatment or exposure to ionizing radiation.

The Global Characterisation of a Drug-Dendrimer Conjugate - PEGylated poly-lysine Dendrimer.

The recent emergence of drug-dendrimer conjugates within pharmaceutical industry research and development introduces a range of challenges for analytical and measurement science. These molecules are very high molecular weight (100-200kDa) with a significant degree of structural complexity. The characteristics and quality attributes that require understanding and definition, and impact efficacy and safety, are diverse.

Strategies for Identity Testing of Therapeutic Oligonucleotide Drug Substances and Drug Products.

A risk-based approach for routine identity testing of therapeutic oligonucleotide drug substances and drug products is described. Risk analysis of solid-phase oligonucleotide synthesis indicates that intact mass measurement is a powerful technique for confirming synthesis of the intended oligonucleotide. Further risk assessment suggests that the addition of a second, sequence-sensitive identity test, which relies on a comparison of some property of the sample to a reference standard of proven identity, results in a sufficient test of identity for most oligonucleotide drug substances and products.

Evaluation of Particle Size Techniques to Support the Development of Manufacturing Scale Nanoparticles for Application in Pharmaceuticals.

The measurement of nanoparticle size, and size distribution, is important to the development of pharmaceutical nanoparticle products and their manufacturing processes. In this work we report on the use of 4 widely-used liquid-phase techniques, dynamic light scattering, differential centrifugal sedimentation, particle tracking analysis, and tuneable resistive pulse sensing to measure 4 different batches of AZD2811NPs. The techniques rely on different physical principles to measure nanoparticle size.

European Pharma Oligonucleotide Consortium: A Move to Consolidate Oligonucleotide Knowledge and Share Experience Within the Community.

A consortium of seven pharma companies has been formed with the aim of sharing knowledge on and harmonizing approaches to oligonucleotide development. This letter aims to raise awareness of this new group and to set expectations for future publications.

Impurities in Oligonucleotide Drug Substances and Drug Products.

This white paper, which is the 10th in a series intended to address issues associated with the development of therapeutic oligonucleotides, examines the subject of product-related impurities. The authors consider chemistry and safety aspects and advance arguments in favor of platform approaches to impurity identification and qualification. Reporting, identification, and qualification thresholds suitable for product-related impurities of therapeutic oligonucleotides are proposed.